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Archive for the ‘Eye Medical Treatment’ Category

How does MS affect vision? Eye symptoms and treatment – Medical News Today

Sunday, October 23rd, 2022

Eye problems are relatively common in people with multiple sclerosis and can include blurred sight, double vision, and vision loss. Multiple sclerosis treatments can help.

As with the other symptoms of multiple sclerosis (MS), eye symptoms can appear during a flare and then fade away over time. Treatments may help protect a persons eyesight, slow the progress of MS, and prevent further damage.

In this article, we look at how MS can affect a persons vision and the treatment options for these symptoms.

Multiple sclerosis (MS) is a progressive disease in which the immune system mistakenly attacks healthy nerve cells. In doing so, it damages the protective coating of these cells, which is called the myelin sheath. Damage to these cells can cause permanent scarring in the brain, leading to a range of symptoms.

Although MS affects each person differently, the National Multiple Sclerosis Society (NMSS) note that vision problems are very often the first symptoms that people with MS experience.

When MS affects the nerves in a persons eyes, it can cause inflammation, leading to symptoms. The official name for the condition is optic neuritis.

A person with optic neuritis may notice various issues with their vision, generally only in one eye. These issues may come on suddenly or slowly. They can be worrying, but they typically fade with time.

People with MS commonly experience some form of vision loss as the disorder progresses.

Vision problems usually affect one eye, and they tend to get worse before getting better. Anyone experiencing these symptoms should contact their doctor immediately, as in some cases, treatment options are available.

Although complete vision loss is possible, it is not as common as other symptoms, such as:

People with MS may experience uncontrollable eye movements called nystagmus.

Nystagmus will not always present the same way, but it often causes one or both eyes to move back and forth repetitively. The person may lose control of how their eye moves in a certain direction. They may also feel as though things are moving when they are not.

The severity of nystagmus can also vary. Some people may experience mild symptoms, while others experience movements that are severe enough to disrupt their vision.

Some people with MS may also experience double vision, or diplopia.

Diplopia occurs when the muscles in the eyes are out of sync because one is not working correctly. As a result, the brain struggles to put together a clear image.

In someone with MS, this occurs when the disorder affects the nerves controlling these muscles.

In the advanced stages, MS may destroy the protective coating around the nerves, leading to permanent changes in eyesight. In a person who regularly experiences vision issues during flare-ups, this may lead to partial or total blindness in one or both eyes.

MS affects each person differently, so there is no telling exactly how long symptoms will last.

Symptoms should subside as the inflammation in the nerve cells goes away. For many people, this is as little as a few weeks. Others may experience symptoms that last up to a year or more.

Some people may find that their symptoms get worse with heat, for example, after a hot shower or on particularly hot days. A high body temperature from exercise or the flu can also exacerbate symptoms in some people.

Symptoms may also worsen as the person uses or strains their eyes all through the day. Anyone experiencing eye symptoms should take regular breaks throughout the day to rest their eyes and avoid unnecessary strain.

Eye symptoms arise when the immune system attacks the myelin sheath of the nerves that control various aspects of the eye. The type of symptoms that a person experiences will vary depending on which nerves sustain damage.

MS is not the only cause of optic neuritis. Other factors that may cause inflammation in the eyes and result in symptoms include:

Scientists do not fully understand the exact cause of MS. However, there is evidence that some people may be more at risk of developing MS. For instance, the NMSS note that a few environmental factors may increase the risk for this condition, including:

However, an increased risk does not mean that these factors directly cause the disorder.

To properly diagnose MS-related eye problems, doctors will need to rule out other conditions. To do so, they may order tests to check for MS or other issues. These tests may include:

Even if the person already knows that they have MS, a thorough diagnosis is important to avoid misdiagnosing another underlying issue.

Most vision problems that occur due to MS eventually improve on their own, but people can still find these symptoms difficult to manage. Continuing to take medication to relieve MS symptoms will help. Doctors may recommend additional treatments if a person is experiencing very severe symptoms.

For instance, if a person has severe vision loss, a doctor may recommend treatments that they would otherwise avoid, such as intravenous steroids.

In other cases, simple methods may help. For instance, doctors may give a person with double vision a temporary eye patch. The patch will block out input from one of the eyes, which should correct the double vision.

Some medications may also help reduce the side effects of vision problems until the flare-up subsides.

It is not possible to completely prevent MS damage to the eyes, but people can take steps to reduce the likelihood of it occurring.

People who are prone to flare-ups in their eyes should rest their eyes regularly throughout the day. Doctors may also recommend that people wear glasses with specific prisms in them that help control disturbances in the eye and reduce symptoms.

There may also be a link between vitamin D levels and the severity of flare-ups. A study in the journal Neurology found that there was an association between vitamin D levels and the severity of optic neuritis.

However, this does not necessarily mean that taking vitamin D will result in a person having less severe attacks. Researchers are performing more comprehensive research, but in the meantime, some doctors recommend that their MS patients take vitamin D supplements to support their body.

Anyone who notices new symptoms or whose symptoms begin to get worse should speak to a doctor who can advise on ways to treat or reduce the effect of symptoms.

MS-related vision problems are common, but the condition will not affect everyone in the same way. Many symptoms will go away on their own without treatment, and the overall prognosis is good.

However, as MS progresses, a persons vision issues are likely to get worse.

Early diagnosis and treatment are important to help reduce symptom severity.

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How does MS affect vision? Eye symptoms and treatment - Medical News Today

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Jan. 6 Prisoner Beaten til He Lost an Eye, Later He Was Tied to Chair …

Sunday, October 23rd, 2022

Ryan Samsel was arrested in January 2021. He was blinded by DC prison guards in one of his many beatings since his arrest.

Ryan Samsel attended the January 6, 2021, protests in Washington DC.

Samsel pushed the flimsy bike racks and stormed the US Capitol after Ray Epps was seen whispering in his ear. Samsel allegedly injured a female police officer.

Since his arrest, Ryan Samsel has been held in a Washington DC prison. On March 21, 2021, Ryan was awakened by correctional officers and his hands were zip-tied. Then they walked him to an unoccupied cell where he was brutally beaten by the officers. Ryan Samsel lost an eye in the beating. His face was smashed. The next day the guards beat him again.

In July 2021 Ryans attorney Joseph McBride joined Greg Kelly on Newsmax to reveal the unbelievable abuse of the Jan. 6 political prisoners in Washington DC.

TRENDING: LIVE-STREAM VIDEO: THOUSANDS Turn Out to See President Donald Trump in Robstown, Texas - Scheduled Start Time at 7 PM CT

This was not an isolated incident.

This is happening in America today.

** Please give to Ryan Samsels GiveSendGo account here. This man desperately needs funding.

On Monday US political prisoners Ryan Samsel, Dominic Pezzola called The Gateway Pundit from their prison block.

Ryan Samsel told The Gateway Pundit that he was beaten by the guards repeatedly, tied to a chair for 12 hours until he developed blood clots. Ryan suffered a broken face and a ruptured kidney. The guards later broke the right side of his face. Now he has precancerous growths on his chest that are spreading and the US government will not allow him medical treatment.

Here is the partial transcript from todays call.

Warning: It is horrifying.

Gateway Pundits Jim Hoft:Hey, tell me something real quick, Ryan. You mentioned something about reaps, and you dont want to say that over the phone? What was that again?

[00:04:06.830] Ryan SamselYeah, I dont want to speak too much over a record of phone about that day with him because I really am in fear of my lifetime. I was assaulted three different occasions. In all three occasions, I had to be taken to the hospital when his name or anything was brought up. And I was in DCG the very first time. And I didnt know exactly what the assault was pertaining, but that morning, Dominic Pezzola had asked why I was assaulted. And Dominic, what did they tell you? This is Dominic. Hell tell you exactly what.

[00:04:54.730] Dominic PezzolaBasically orders from the FBI. All the treatment we were getting.

[00:04:59.050] Jim HoftOkay, Dominic.

[00:05:01.300] Jim HoftCan you tell your last name, too? Tell everybody your last name.

[00:05:04.690] Dominic Pezzola.Pezzola.

[00:05:05.390] Jim HoftP-E-Z-Z. Got it. Dominic Pezzola.

[00:05:11.050] Dominic Pezzola.I was the first one to see Ryan after they beat him. They beat him good. I mean, his eyes were swollen shut, black and blue and everything.

[00:05:18.430] Jim HoftOh, my God. Thats awful. And then they didnt give him treatment or they did?

[00:05:24.080] Ryan SamselNo.

[00:05:25.690] Dominic Pezzola.Well, let me put him back on the phone. He can probably tell you better.

[00:05:27.900] Jim HoftOkay.

[00:05:29.050] Ryan SamselWhats up, Jim? Hey.

[00:05:31.150] Jim HoftYeah, I was just going to say, did they give you a treatment after they found you? Beat up Dominic? Found you?

[00:05:36.290] Ryan SamselNo. So they took me to the hospital, and Howard University Hospital found I had a blood clot, my left shoulder, and I had a broken face, I had a broken nose, a ruptured kidney, and they ordered I get further treatment, and they never gave me that. So then I went to a vascular surgeon after the assault in Virginia, and she said she recommended that I go to physical rehab. And the prosecutor, which name is Karen Rocklin, she denied me that. And then when I went to Warsaw, thats where I got the worst beaten. They broke the right side of my face, and I have a blood clot and my right head, and they left me in a chair for about ten to 12 hours.

[00:06:21.560] Jim HoftAnd I tied to a chair or what?

[00:06:23.760] Ryan SamselYeah, its a corner-strength chair. They tie me in the chair for 12 hours, and I end up getting a blood clot in my right leg. And I asked because I know what the blood clots feel like. And when I asked and then they tried to cover it up. And they forced me to take this. They squirt the stuff up my nostril and said that I overdosed on drugs. And then when they tested me for drugs, I obviously came up negative. So they tried to cover up, but when I went to the hospital, the doctor at the hospital was the same doctor at the jail. Its the same doctor. And he had to mark that it was an assault. And they took pictures. And from there, they transferred me out.

Now Ryan has precancerous growths and the government will not allow him medical treatment.

This is America under the new totalitarians.

** Please give to Ryan Samsels GiveSendGo account here. This man desperately needs funding.

** And here is Dominic Pezzolas GiveSend Go account. Please help this man and his family.

Here is our phone call with Ryan Samsel and Dominic Pezzola.

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Broken eye socket: Pictures, causes, and treatment – Medical News Today

Sunday, October 23rd, 2022

A broken eye socket usually causes intense pain, swelling, and a black eye, which make it easy to diagnose.

The eye socket is the bony structure surrounding and protecting the eye. In addition to the eye, it houses all the muscles, nerves, and connective tissues that connect to and move the eye.

Some parts of the eye socket are hard, thick, and difficult to break. Other areas are fragile and more prone to breaking.

In this article, we look at the symptoms of a broken eye socket, as well as the different types of fracture that can occur. A broken eye socket always requires medical attention, but treatment and recovery times can vary according to the severity of the break.

The eye socket is also called the orbit. While it feels like one solid structure, it consists of seven different bones that connect to create four different areas.

A fracture can occur in any one of these areas, creating different injuries:

The main symptom of a broken eye socket is pain around the eye. Depending on the type of fracture and its severity, the additional symptoms below may also occur:

Accidental injuries are the most common overall cause of eye socket fractures. Fractures to the thicker bones in the eye socket may be more common following traumatic events, such as falling from a height or having a car accident.

Sports injuries can cause a broken eye socket, especially sports where a ball or stick can hit the face. Using tools such as hammers, drills, and power saws may also increase a persons risk of eye injuries.

Other causes include physical assaults and fighting. A punch or kick in the eye may be enough to lead to an indirect floor fracture if the pressure on the eye is too much for the thin bone to withstand.

In most cases, a doctor will make an initial diagnosis after physically inspecting the eye. They may also check eye pressure and ask questions about the persons vision, such as whether the eye can look in all directions.

To help confirm the diagnosis, doctors use imaging tests like X-rays and CT scans.

The individual may need referring to a specialist to ensure that they receive comprehensive treatment. For example, an ophthalmologist can help diagnose vision damage, and a neurologist can advise on any nerve damage.

Many broken eye sockets heal without surgery. If doctors believe that the fracture can heal naturally, they may recommend some complementary treatments, including antibiotics to prevent infections and special nasal sprays to stop the person sneezing.

Other tips to help people feel more comfortable while the eye socket heals include:

Doctors may also recommend that people avoid sneezing or blowing their nose while the eye socket is healing. These actions can put unnecessary pressure on the fracture and may spread bacteria from the sinuses to the injured eye socket.

While the swelling and bruising may start to improve after a week or so, the fracture can take much longer to heal. Recovery time varies greatly depending on how severe the fracture is and whether or not there are any infections or other complications.

Surgery for a broken eye socket can be risky and is not always the best treatment method. If surgery is necessary, the surgeon may wait a few weeks until the swelling in the eye reduces.

Specific symptoms that may require surgery include:

A reconstructive surgeon that deals with eye injuries may perform the surgery. Depending on the specific fracture, the surgical procedures may include:

It is not always possible to prevent accidents, but taking measures to protect the eyes and face may help reduce the chances of breaking the eye socket. Preventative measures include:

Anyone experiencing symptoms of a broken eye socket should seek immediate medical attention. With proper treatment, the outlook for eye socket fractures is good.

Even when surgery is necessary to repair a fracture, it is likely that the fracture will heal without long-term complications.

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Eye parasites: Types, treatment, and prevention – Medical News Today

Sunday, October 23rd, 2022

Some parasites can infect humans. Once inside of a body, parasites can travel to different organs, including the eyes. Without treatment, these infections can lead to eye pain, vision problems, and in some cases, blindness.

Parasites are organisms that live in, or on, another organism. The host organism provides the parasites with ideal living conditions and a source of nutrients. Most parasites damage their hosts in some way.

The Centers for Disease Control and Prevention (CDC) identifies three types of parasites that cause diseases in humans. These are:

Most parasites secrete toxic substances, damaging their hosts. These substances can destroy the tissue or cause inflammation.

This article looks at some parasitic infections of the eyes. It also looks at how doctors treat parasitic infections and how people can prevent them.

Acanthamoeba keratitis is a rare but serious eye infection that occurs due to a single-celled organism called an amoeba. These are present in bodies of water, the soil, and the air.

Acanthamoeba parasites infect the cornea, the transparent covering of the eye. Without treatment, Acanthamoeba keratitis can lead to severe pain, and in some cases, loss of vision.

Although anyone can develop the infection, in the United States, approximately 85% of infections develop in those who wear contact lenses.

Symptoms can include:

Toxoplasma gondii is another common protozoan parasite. The CDC estimates that as many as 11% of people 6 years old and older have the infection in the US.

If a person develops the infection during, or just before, pregnancy, toxoplasmosis can damage the fetus eyes.

Most people contract the parasite as a result of eating undercooked meat or shellfish. Pets, including cats and dogs, can pass on the infection through their feces.

The CDC notes that most people will not experience symptoms. However, others may feel as if they have the flu. They will develop swollen lymph glands and aching muscles for a month or more.

If it affects the eyes, a person may experience:

A parasitic worm called the Onchocerca volvulus causes onchocerciasis. A person can contract the parasite due to repeated bites from infected blackflies. The flies carry microscopic worm larvae that penetrate a persons skin.

These worms can cause lesions in the eyes, which can lead to blindness. If the worms infect the optic nerve, cornea, or retina, the resulting inflammation can also lead to vision loss.

People are most likely to contract the infection in tropical areas. The World Health Organization (WHO) notes that over 99% of people with the infection live in thirty-one countries in sub-Saharan Africa. Those most at risk of contracting the infection live or work near fast-flowing water, such as rivers and streams.

People may not develop any symptoms. However, if symptoms do occur, a person may experience:

Severe symptoms include visual impairment and vision loss.

Toxocara are parasitic roundworms that often infect cats and dogs. The worms eggs pass through the infected animals intestines and contaminate their feces.

People contract the infection if they accidentally swallow contaminated dirt.

Many people who contract the infection do not present with symptoms and do not become ill. However, if the larvae travel to the hosts eyes, they can cause swelling and scarring on the retina, which can lead to vision loss.

Ocular toxocariasis usually only occurs in one eye.

Tiny mites, called Demodex folliculorum, live in the hair follicles on human skin.

They are usually harmless, but when their numbers increase on the face, they can cause eye problems.

People with large numbers of these mites in their eyelashes may develop:

Loa loa is a parasitic worm from West and Central Africa. It causes loiasis, or African eye worm.

The CDC states that people are most at risk of infection if they live in, or visit, rain forests of the area, and are repeatedly bitten by deerflies.

People typically contract the infection after being bitten by deerflies for many months. However, a person can contract the infection after less than 30 days.

Symptoms do not typically develop, but if they do, they can take months to show up. People may develop itching and swelling, most commonly in the joints.

If the worms travel to a persons eyes, it can make them itchy, painful, and sensitive to light. People may see a worm crawl across the surface of the eye.

Gnathostomiasis is another infection that occurs due to a parasitic worm.

Although these worms are present throughout the world, most diagnoses occur in Southeast Asia, Thailand, and Japan.

People can pick up the parasites if they eat raw or undercooked freshwater fish carrying the larvae.

Symptoms develop as the parasite moves through the body.

According to the CDC, as the parasite moves through the wall of the intestine, stomach, or liver, a person may experience:

This can last for 23 weeks.

As the parasite moves under the skin, people experience itchy swellings under their skin. This occurs 34 weeks after ingestion, but it can last for up to 10 years.

Although it is rare, it can enter other parts of the body, including the eyes. This can lead to vision loss or blindness.

Depending on the type of infection, doctors may prescribe antiparasitic drugs. Doctors use different drugs for each group of parasites.

For example, doctors treating worm infestations may use vermicides or vermifuges. Vermicides kill the worms, while vermifuges help expel the worms from a persons body.

Treatments may include eye drops, oral medicines, or in some cases, surgery to remove the parasites from the eye.

Not all parasitic infestations are preventable, but there are several ways people can reduce their risk of contracting an infection.

People should make sure they only eat properly cooked food, and that they drink water from a clean source, especially if they are traveling to an area where infections are high.

Many biting insects transmit infections, and these can be active at any time of day. A person can reduce the risk of insect bites by keeping all of their skin covered and using an insecticide on their skin.

People who wear contact lenses need to practice good hygiene before handling their lenses and use sterile solutions to store them. The American Optometric Association (AOA) cautions against using tap water, even when rinsing lens cases.

Gardeners, pet owners, and people who work outside regularly should wash their hands thoroughly after handling any dirt or feces.

Many people do not experience any symptoms of parasites, but the American Academy of Ophthalmology (AAO) recommends speaking to an ophthalmologist if a person has any unusual vision symptoms. These include:

People may also experience the sensation that something is in their eye.

Parasites can infect the eyes, and in some cases, lead to blindness.

Although many infections do not cause symptoms, anyone experiencing pain or discomfort in, or around, the eye should speak with a doctor.

Doctors can treat many infections with antiparasitic medicines before any lasting damage occurs.

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Optometrists call on Newsom to sign bill to expand eye care – HDDailyNews

Monday, September 12th, 2022

Doctor of Optometry Ron Kleinman, left, performs an eyesight prescription test on patient Gloria McKinney at the Remote Area Medical (RAM) clinic inside the Los Angeles Sports Arena.

(The Center Square) Health officials and optometrists are calling on Gov. Gavin Newsom to sign a bill on his desk that would allow qualified optometrists to perform certain advanced procedures, a measure supporters say will improve access to eye care for all Californians.

Assembly Bill 2236,sponsored by Assemblymember Evan Low, would allow optometrists who are certified to treat glaucoma to perform certain other advanced procedures if they meet other education and training requirements.

Specifically, the bill would allow optometrists who complete additional certifications and training to use certain types of lasers for treatment and remove skin tags or non-cancerous lesions that are smaller than five millimeters.

The bill comes as Californians across the state are waiting months for specialty eye care treatment, as ophthalmology care can be difficult for many patients to access. Thirteen out of Californias 58 counties have no ophthalmologists, six counties have just one ophthalmologist and two counties have two ophthalmologists, according to a news release from the California Optometric Association.

Health officials say it will help address the crisis level of limited specialty eye care and increase access to treatment for many Californians by authorizing optometrists who receive additional training and certification to perform minimally invasive procedures.

We have the pieces in place to increase access optometrists are out there, optometrists are willing, optometrists are trained, Jeffrey Garcia, optometrist and member of the California State Board of Optometry, told reporters Thursday. We just need the governor to sign this bill to give us that opportunity.

Garcia, who practices in Kings County in Californias central valley, said it is extremely hard for patients to access ophthalmology care, particularly Medi-Cal beneficiaries. Garcia said Kings and Tulare counties have no ophthalmologists that accept Medi-Cal, which leaves one ophthalmologist who accepts Medi-Cal in Fresno County to see over 600,000 patients within their health service area.

If Newsom signs this bill, California will join 10 other states that allow optometrists to use lasers and 17 other states that authorize them to remove skin tags. Officials said Thursday that optometrists in other states are already performing all procedures included in the bill.

The bill was opposed by the California Medical Association as it moved through the legislature, despite amendments taken to require optometrists seeking certification for advanced procedures to complete at least 43 complete surgical procedures on live human patients.

While the latest amendments increase the number of required surgeries to 43, that number is far below the clinical education requirements of ophthalmology residency programs, CMA wrote in opposition.

Supporters contend, however, that the law would implement the nations strictest standards for the training and certification of optometrists before they can perform these procedures, John Flanagan, dean of the Herbert Wertheim School of Optometry & Vision Science at UC Berkeley, told reporters.

The bottom line is that AB 2236 will help patients access the care they need, Flanagan said. As the dean of UC Berkeleys optometry school, I can say confidently that the training measures in the bill protect the quality and safety of that care.

Supporters of AB 2236 said Thursday they are hopeful the bill will earn Newsoms signature. The measure is among hundreds of bills currently sitting on Newsoms desk with a Sept. 30 deadline to be signed.

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Xinjiang report: China must address grave human rights violations and the world must not turn a blind eye, say UN experts – OHCHR

Monday, September 12th, 2022

GENEVA (7 September 2022) Independent UN experts* said today that profound concerns over systematic human rights violations and their widespread effect on individuals and minorities in Chinas Xinjiang Uyghur Autonomous Region cannot, and should not, be ignored by the international community. They repeated a call for the Human Rights Council to convene a special session on China.

In supporting the recently released assessment by the UN Human Rights Office on allegations of abuses in Xinjiang, the experts highlighted the conclusion from the assessment that the extent of arbitrary and discriminatory detention of members of Uyghur and other predominantly Muslim minorities may constitute international crimes, in particular crimes against humanity. They also drew attention to the reports findings of credible allegations of patterns of torture or ill-treatment, including forced medical treatment and adverse conditions of detention, as well as incidents of sexual and gender-based violence including invasive gynaecological exams, and indications of coercive enforcement of family planning and birth control policies.

The experts described the assessment, released on 31 August 2022, as comprehensive and principled, adding that it built on and backed the findings and views of multiple Special Procedure mandate holders and Working Groups.

The experts welcomed the attention given in the report to widespread misuse of counter-terrorism and counter-extremism laws, policies and practice.

The experts are particularly concerned that both UN human rights mechanisms in tandem with this assessment demonstrate that: Chinas policies and practices have limited the legitimate exercise of the right to freedom of religion or belief, the right to family life including reproductive rights for women, freedom of opinion and expression, the right to assemble and associate peacefully, the right to privacy, the right to cultural life, and the right to live free from arbitrary detention, forced labour as well as freedom from any violation of the right to life and from torture, inhuman and degrading treatment and from enforced disappearance as well as the right of religious and ethnic minorities to enjoy their own culture, to profess and practice their own religion, or to use their own language.

The experts said they endorse and support all the recommendations made by the UN Human Rights Office and offer their support to facilitate the implementation of these recommendations. They called on the Government to invite mandate holders and affirmed their availability to undertake country visits, as well as to provide technical assistance and support to the Government.

The experts also reiterated recommendations made in their June 2020 joint statement, urging the Human Rights Council to hold a special session to address human rights issues more broadly in China precisely because key issues of concern, especially arbitrary detention, enforced disappearances, restrictions to movement, privacy, freedom of religion, freedom of expression are occurring in other parts of the country premised on grounds of national security. The Human Rights Council should urgently consider the creation of a Special Procedures mandate, or a panel of experts to closely monitor, analyse and report annually on the human rights situation in China; the General Assembly or Secretary-General should consider the creation of a special envoy; and they urge UN Member States and UN agencies and business enterprises to demand that China fulfils its human rights obligations, including during their ongoing dialogues with the Government.

ENDS

The experts: Fionnuala N Aolin,Special Rapporteur on the promotion and protection of human rights while countering terrorism;Alice Edwards, Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, Siobhn Mullally, Special Rapporteur on trafficking in persons, especially women and children; Clment Nyaletsossi Voule,Special Rapporteur on the rights to freedom of peaceful assembly and of association; Balakrishnan Rajagopal, Special Rapporteur on adequate housing as a component of the right to an adequate standard of living, and on the right to non-discrimination in this context; Attiya Waris,Independent Expert on the effects of foreign debt and other related international financial obligations of States on the full enjoyment of all human rights, particularly economic, social and cultural rights; Tomoya Obokata, Special Rapporteur on contemporary forms of slavery, including its causes and consequences; Luciano Hazan (Chair-Rapporteur), Aua Bald (Vice Chair), Grayna Baranowska, Gabriella Citroni and Angkhana Neelapaijit,Working Group on Enforced or Involuntary Disappearances; Ana Brian Nougrres,Special Rapporteur on the right to privacy; Tlaleng Mofokeng, Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health; Miriam Estrada-Castillo(Chair-Rapporteur),Mumba Malila(Vice-chairperson),Elina Steinerte, Priya Gopalan,Matthew Gillett,Working Group on arbitrary detention;Nazila Ghanea,Special Rapporteur on freedom of religion or belief; Reem Alsalem, Special Rapporteur on violence against women and girls, its causes and consequences; Fernand de Varennes, Special Rapporteur on Minorities Issues; Sorcha MacLeod(Chair-Rapporteur), Jelena Aparac, Ravindran Daniel, Chris Kwaja, Carlos Salazar Couto,Working Group on the use of mercenaries; Irene Khan,Special Rapporteur on the promotion and protection of the right to freedom of opinion and expression; Melissa Upreti(Chair),Dorothy Estrada Tanck(Vice-Chair),Elizabeth Broderick,Ivana Radai, andMeskerem Geset Techane,Working Group on discrimination against women and girls; Tendayi Achiume, Special Rapporteur on contemporary forms of racism, racial discrimination, xenophobia and related intolerance; Alexandra Xanthaki, Special Rapporteur in the field of cultural rights; Farida Shaheed, Special Rapporteur on the right to education; Claudia Mahler Independent Expert on the enjoyment of all human rights by older persons; Morris Tidball-Binz,Special Rapporteur on extrajudicial, summary or arbitrary executions; Fabin Salvioli, Special Rapporteur on the promotion of truth, justice, reparation and guarantees of non-recurrence; Fernanda Hopenhaym(Chairperson), Elbieta Karska,Robert McCorquodale,Damilola OlawuyiandPichamon Yeophantong (Vice-Chairperson),Working Group on Business and Human Rights; Michael Fakhri, Special Rapporteur on the right to food.

The Special Rapporteurs, Independent Experts and Working Groups are part of what is known as theSpecial Proceduresof the Human Rights Council. Special Procedures, the largest body of independent experts in the UN Human Rights system, is the general name of the Councils independent fact-finding and monitoring mechanisms that address either specific country situations or thematic issues in all parts of the world. Special Procedures experts work on a voluntary basis; they are not UN staff and do not receive a salary for their work. They are independent from any government or organization and serve in their individual capacity.

UN Human Rights, country page China

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Xinjiang report: China must address grave human rights violations and the world must not turn a blind eye, say UN experts - OHCHR

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Bausch + Lomb and Novaliq Announce U.S. FDA Filing Acceptance for Investigational Treatment NOV03 (Perfluorohexyloctane) – BioSpace

Monday, September 12th, 2022

PDUFA Action Date is June 28, 2023

VAUGHAN, Ontario and HEIDELBERG, Germany, Sept. 6, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eye drop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). NOV03 has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.

"With the FDA commencing review of the NDA filing, we are one step closer to bringing an important new treatment option to the millions of Americans affected by dry eye disease associated with Meibomian gland dysfunction," said Joseph C. Papa, CEO, Bausch + Lomb. "NOV03 is distinct from anti-inflammatory and immunomodulatory agents, and, if approved, would be the first prescription eye drop to address excessive tear evaporation. The approval would also mark a significant milestone for Bausch + Lomb, as the company's first FDA approval for a prescription medicine since becoming a publicly traded company earlier this year."

DED is one of the most common ocular surface disorders, with MGD as a major cause of development and progression, affecting approximately nine out of 10 people with DED.1,2 DED due to MGD is caused by a deficient tear film lipid layer that leads to increased tear evaporation.3 There is currently no approved prescription eye drop in the United States for DED associated with MGD.

"We are thrilled the FDA has accepted our NDA filing for NOV03," said Christian Roesky, Ph.D., CEO, Novaliq. "With only limited treatment options currently available, NOV03 is a promising potential new therapy, specifically designed to alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction."

The clinical development program for NOV03 includes two Phase 3 studies (GOBI and MOJAVE), both of which demonstrated statistically significant improvement vs. control for both primary and key secondary sign and symptom endpoints as early as day 15 and through day 57. NOV03 was well tolerated in both studies.

About NOV03 (perfluorohexyloctane) Ophthalmic SolutionNOV03 (perfluorohexyloctane) is an investigational, proprietary, water-free, non-steroidal, single-component preservative-free eye drop.4In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 inthe United StatesandCanada.Data from the first pivotal Phase 3 trial (GOBI) were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C. on April 24, 2022. Data from the second pivotal Phase 3 trial (MOJAVE) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. Results from the pivotal Phase 2 trial (SEECASE) were published in Cornea in September 2021.5 The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).

About NovaliqNovaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. NovaliqGmbH is headquartered inHeidelberg,Germanyand Novaliq Inc. has an office inCambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More onwww.novaliq.com.

About Bausch + LombBausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with more than 12,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visitwww.bausch.comand connect with us on Twitter, LinkedIn, Facebook and Instagram.

Forward-looking StatementsThis news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb's filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

References

All product/brand names and/or logos are trademarks of the respective owners. 2022 Bausch & Lomb Incorporated or its affiliates.NOV03.0016.USA.22

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A new technology ROTA developed by HKUMed and CU Medicine can visualise axonal fibre bundles on the retina to advance early diagnosis of glaucoma and…

Monday, September 12th, 2022

A research team led by the Department of Ophthalmology, School of Clinical Medicine, LKS Faculty of Medicine of The University of Hong Kong (HKUMed), with collaborators from the Faculty of Medicine of The Chinese University of Hong Kong (CU Medicine) and local and international partners, have developed a new technology ROTA (Retinal nerve fibre layer Optical Texture Analysis) to unveil the optical texture and trajectories of the axonal fibre bundles on the retina. ROTA outperforms the current clinical standards, attaining 15.0% to 28.4% higher in sensitivity in detecting early optic nerve damage in glaucoma the leading cause of irreversible blindness. The research has been published in Nature Biomedical Engineering1[link to publication].

BackgroundGlaucoma is the most common form of neurodegenerative disease. Whereas clinical diagnosis of glaucoma is predicated on the measurement of retinal nerve fibre layer (RNFL) thickness, typically obtained with a non-invasive digital imaging device, optical coherence tomography (OCT)2, false positives and false negatives are common, which renders clinical interpretation of OCT findings difficult, even for glaucoma specialists. This is supported by a meta-analysis reporting that the sensitivities of best-performing OCT parameters for detection of RNFL thickness abnormalities were only 65%-75% at specificities of 90%-95%3.

Research findings and significanceROTA is a patented algorithm (US Patent No. 10,918,275)4that integrates RNFL thickness and RNFL reflectance measurements obtained from standard OCT scans to discern the optical texture and trajectories of the axonal fibre bundles and reveal RNFL defects. ROTA can detect focal RNFL defects that are missed by standard clinical tests. Compared with OCT, ROTA can increase the sensitivity of detecting early optic nerve damage in glaucoma by 15-22%. At 95% specificity, the sensitivity of ROTA was 97.3-98.4% for detection of early glaucoma, 15.0% to 28.4% higher than the current clinical standards. HKUMed is working with the University of California San Diego (UCSD), the United States, to apply ROTA in research and patient care, while patients can find the application of ROTA at HKU Eye Centre and Southern District Hong Kong Eye Survey.

In a diagnostic study examining 177 healthy individuals and 363 glaucoma patients at the CUHK Eye Centre of CU Medicine, ROTA attained significantly higher sensitivity and specificity than conventional OCT RNFL thickness analysis to detect glaucoma1. Furthermore, ROTA is able to identify axonal fibre bundle damage in optic neuritis, ischemic optic neuropathy, and compressive optic neuropathy.

We are delighted to have worked with CU Medicine to develop ROTA, which brings new hope to early identification and timely treatment of glaucoma due to its high sensitivity and specificity, said Professor Christopher Leung Kai-shun, Chairperson and Clinical Professor of the Department of Ophthalmology, School of Clinical Medicine, HKUMed. Our next steps include enrolling patients from Queen Mary Hospital, Grantham Hospital, and Hong Kong Eye Hospital for longitudinal studies to examine the effectiveness of ROTA for detection of glaucoma progression, as well as working with OCT industrial partners to deploy ROTA in clinical care. Furthermore, HKU Eye Centre welcomes patients with questionable diagnosis of glaucoma for ROTA assessment.

Professor Clement Tham Chee-yung, Chairman of the Department of Ophthalmology and Visual Sciences and S.H. Ho Professor of Ophthalmology and Visual Sciences, CU Medicine, remarked, Glaucoma can lead to irreversible loss of vision, if it is not diagnosed and treated early. In Hong Kong, about 25% of irreversible blindness is caused by glaucoma, and there are more about 100,000 glaucoma patients suffering from various levels of visual disability. Achieving earlier diagnosis of glaucoma and detection of progression through advanced imaging technologies is essential. I am glad that ROTA was developed by CU Medicine and HKUMeds collaboration and now it can be used in clinical practice.

Clinical applicationsROTA underpins a highly sensitive and specific technique to advance the diagnosis of glaucoma and optic neuropathies. ROTA will be deployed on the Advanced Nerve and Glaucoma Imaging Network (ANGI Network), which comprises ophthalmologists, neuro-ophthalmologists and clinical researchers around the world. The committee members of ANGI Network include world-leading institutions in glaucoma research such as HKU, Asan Medical Center (Korea), Beyer Eye Institute at Stanford University (US), Moorfields Eye Hospital (UK), NTU Langones Eye Center (US), and University College London (UK).

About the research teamThis research was directed by Professor Christopher Leung Kai-shun, Chairperson and Clinical Professor of the Department of Ophthalmology, School of Clinical Medicine, as well as Director of HKU Eye Centre, HKUMed, the corresponding author of the study, and Dr Alexander Lam Ka-ngai, Research Officer of the Department of Ophthalmology, School of Clinical Medicine, HKUMed. Co-authors include Dr Carol Cheung Yim-lui, Associate Professor; Dr Kelvin Wan Ho-nam, Clinical Assistant Professor (Honorary); Dr Mandy Wong, Clinical Assistant Professor (Honorary); Dr Carmen Chan, Clinical Associate Professor (Honorary); Dr Noel Chan, Clinical Assistant Professor (Honorary); Dr Kam Ka-wai, Clinical Assistant Professor (Honorary) and Dr Lin Chen from the Department of Ophthalmology and Visual Sciences at CU Medicine; Professor Robert N. Weinreb, Chair and Distinguished Professor of the Department of Ophthalmology at UCSD; Professor Ted Garway-Heath, IGA Professor of Ophthalmology at the UCL Institute of Ophthalmology; Dr Marco Yu from Singapore Eye Research Institute; Philip Guo Yawen, Vivian Chiu and Gilda Lai from the Department of Ophthalmology, School of Clinical Medicine, HKUMed.

AcknowledgementsThe research was supported by the General Research Fund (14101518), Hong Kong University Grants Committee and the Technology Start-up Support Scheme for Universities (2019-2020), Hong Kong Innovation and Technology Commission.

Media enquiriesPlease contact LKS Faculty of Medicine of The University of Hong Kong by email (medmedia@hku.hk).

1Leung CKS, Lam AKN, Weinreb RN, Garway-Heath DF, Yu M, Chiu V, Wan K, Wong M, Wu K, Cheung CY, Lin C, Chan C, Chan NC, Kam KW, Lai G. Diagnostic assessment of glaucoma and non-glaucomatous optic neuropathies via Retinal nerve fiber layer Optical Texture Analysis. Nature Biomedical Engineering Published 2022;6(5):593-604.

2Weinreb RN, Leung CK, Garway-Heath DF, Medeiros FA, Liebmann J. Consensus series 8 Diagnosis of primary open angle glaucoma (Kugler Publications, 2016).

3Oddone F, Lucenteforte E, Michelessi M, et al. Macular versus Retinal Nerve Fiber Layer Parameters for Diagnosing Manifest Glaucoma: A Systematic Review of Diagnostic Accuracy Studies. Ophthalmology. 2016;123:939-49.

4Leung CKS, Lam AKN. Optical Texture Analysis of the Inner Retina (US20190110681).

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IDEAYA Reports Positive Interim Phase 2 Clinical Results for Darovasertib and Crizotinib Synthetic Lethal Combination in Metastatic Uveal Melanoma -…

Monday, September 12th, 2022

SOUTH SAN FRANCISCO, Calif., Sept. 11, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients (ClinicalTrials.gov Identifier: NCT03947385).

"The confirmed partial responses and high percentage of patients with tumor shrinkage shown in these interim Phase 2 data are extremely encouraging for patients with metastatic uveal melanoma. The 50% overall response rate and greater than 5 months median progression free survival observed in first-line MUM patients reflects the potential for a compelling clinical efficacy profile irrespective of haplotype (HLA-A*02:01) status. The partial responses shown in first-line and any-line MUM patients are clinically significant and build on previously-reported results for any-line MUM patients, now with a larger patient data set," said Dr. Marlana Orloff, M.D., Associate Professor, Sidney Kimmel Cancer Center, Jefferson Health.

"The clinical efficacy observed in first-line patients in these interim Phase 2 data presents an opportunity to pursue a front-line strategy and provides a rationale for a potential registration-enabling clinical trial in MUM," said Dr. Matt Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences.

There are currently no FDA approved therapies for GNAQ and GNA11 solid tumors, and current therapies for MUM have relatively low objective response rates and short median progression free survival (PFS), highlighting the high unmet medical need. Approximately 90% of MUM has either a GNAQ or GNA11 mutation that activates the protein kinase C (PKC) signaling pathway. The historical overall response rate (ORR) in MUM clinical trials has generally been reported with an ORR ranging from approximately 0 to 5%, including: pembrolizumab and tebentafusp (each ~5%); MEK inhibitor selumetinib in combination with dacarbazine (~3%); and cMET inhibitor cabozantinib monotherapy (~0%). In addition, the historical median PFS in MUM clinical trials has been reported ranging from approximately 2.0 to 2.8 months, including: tebentafusp (~2.8 months, IMCgp100-102 study); MEK inhibitor selumetinib in combination with dacarbazine (~2.8 months); and cMET inhibitor cabozantinib monotherapy (~2.0 months).

Darovasertib (IDE196) is a small molecule, potential first-in-class protein kinase C (PKC) inhibitor. IDEAYA is evaluating the synthetic lethal combination of darovasertib and crizotinib, a small molecule cMET inhibitor, in MUM and other GNAQ/11 tumors pursuant to a clinical trial collaboration and drug supply agreement with Pfizer.

Clinical Data Update Darovasertib and Crizotinib Combination in MUM The interim Phase 2 clinical data update is based on an initial thirty-seven (37) patients enrolled in the darovasertib and crizotinib combination study at the expansion dose of 300mg twice-a-day darovasertib and 200mg twice-a-day crizotinib, as of the data analysis cutoff date of June 26, 2022. Out of the thirty-seven (37) patients enrolled, there were thirty-five (35) evaluable patients and two (2) non-evaluable patients. The two (2) non-evaluable patients were both pretreated and withdrew from the trial prior to the first scan. Neither of the two non-evaluable patients progressed due to disease: one (1) patient withdrew consent and one (1) patient discontinued early due to fatigue. Reported data are preliminary and based on an unlocked database as of the data analyses cutoff date, except one confirmatory scan after the data cutoff date or as otherwise noted. Enrollment in the darovasertib and crizotinib combination expansion dose cohort of the clinical trial is ongoing.

The company observed encouraging clinical activity in Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients in the expansion dose cohort. These investigator-reviewed data by RECIST 1.1 include:

These data provide robust clinical proof-of-concept for the efficacy of the darovasertib and crizotinib synthetic lethal combination treatment.

The darovasertib and crizotinib combination therapy has a manageable adverse event profile in MUM patients (n=37), with a low rate of drug-related serious adverse events (SAE's). Patients reported predominantly Grade 1 or 2 drug-related adverse events: all patients experienced a drug-related AE, of which 76% were reported as Grade 1 or 2 and 24%were reported as Grade 3. No patients observed Grade 4 or Grade 5 AE's. One patient discontinued treatment due to a drug-related adverse event.

The potentially addressable patient population for metastatic uveal melanoma is estimated to include over 4,000 patients across US and Europe, based on estimated annual incidence. As an orally-administered small molecule precision medicine therapeutic, with demonstrated anti-tumor activity and manageable adverse event profile, the company considers the darovasertib and crizotinib combination therapy to have the potential to be broadly impactful to the MUM patient population.

IDEAYA is currently targeting to initiate a potential registration-enabling trial in Q1 2023. The company is evaluating first-line MUM as a potential registrational regulatory strategy. As of August 31, 2022, IDEAYA has enrolled 21 first-line MUM patients at the expansion dose of the darovasertib and crizotinib combination study.

Darovasertib (Neo)Adjuvant Uveal Melanoma and Other Potential Expansion OpportunitiesIDEAYA is also evaluating the potential for darovasertib in other oncology indications, including as (neo)adjuvant therapy in primary uveal melanoma (UM), in cMET-driven tumors and in KRAS-mutation tumors.

(Neo)Adjuvant UM represents a significant expansion opportunity for darovasertib with a potential annual incidence of approximately 8,700 patients aggregate in US and Europe.

The company has observed preliminary proof of concept for potential darovasertib use in the (neo)adjuvant uveal melanoma setting, including responses of the primary orbital tumor. Clinical data reflects an observed tumor shrinkage by investigator review of primary ocular lesions in 5 of 5 (100%) UM or MUM patients treated as monotherapy or in combination with Crizotinib, including preliminary observation of tumor reductions in uvea lesion of two patients after the data cut-off date of August 19, 2022:

"I am excited to explore the potential for darovasertib as a (neo)adjuvant approach for the treatment of uveal melanoma patients. The observed clinical experience provides a basis for clinical investigation to evaluate whether darovasertib, can improve current primary treatment paradigms, which typically include radiotherapies and/or enucleation of the eye," said Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology Site Lead at Princess Margaret Cancer Centre inToronto,Canada, and Ocular Melanoma Physician Task Force ofCanadaCo-Lead.

IDEAYA is supporting St. Vincent's Hospital Sydney Limited, which has initiated an Investigator Sponsored Trial, or IST, captioned as the "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM) study, to evaluate darovasertib monotherapy in a neo-adjuvant and adjuvant setting in primary UM patients. IDEAYA is targeting initiation of a company-sponsored clinical trial in Q4 2022 to further evaluate darovasertib monotherapy in (neo)adjuvant uveal melanoma, and is evaluating potential near-term clinical endpoints such as vision and organ preservation.

IDEAYA Investor Webcast and Conference CallIDEAYA will host an investor webcast and conference tomorrow morning, September 12, 2022 at 8:00 am ET, to present darovasertib and crizotinib Phase 2 interim clinical efficacy and tolerability data, as well as clinical landscape, potential registrational strategies and expansion opportunities.

Presenters at the investor webcast and conference call will include Dr. Marlana Orloff, M.D., Associate Professor, Sidney Kimmel Cancer Center, Jefferson Health, and Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Melanoma/Skin Oncology Site Lead at Princess Margaret Cancer Centre inToronto,Canada, and Ocular Melanoma Physician Task Force ofCanadaCo-Lead, each of whom are key opinion leaders and clinical investigators. Yujiro S. Hata, President and Chief Executive Officer, and other members of the IDEAYA management team will also present.

IDEAYA's darovasertib investor webcast presentation, as well as an updated corporate presentation, will be available on the company's website, at its Investor Relations portal (https://ir.ideayabio.com/) in advance of the investor webcast presentation at approximately 6:00 am ET.

Corporate UpdatesIDEAYA had cash, cash equivalents and marketable securities of approximately $324 million as of June 30, 2022, which it currently projects will be sufficient to fund its planned operations into 2025.

About IDEAYA BiosciencesIDEAYA is a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality which represents an emerging class of precision medicine targets.

Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to (i) timing for initiating potential registration-enabling trial in MUM, (ii) potential clinical efficacy profile, and (iii) timing of initiation of a company-sponsored clinical trial for in Q4 2022 to further evaluate to evaluate darovasertib in a neo-adjuvant and adjuvant setting in primary UM patients. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, the ongoing military conflict between Russia and Ukraine, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Quarterly Report on Form 10-Q filed on August 15, 2022 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

SOURCE IDEAYA Biosciences, Inc.

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Advancing a Treatment for a Common Eye Disease That Lacks One – Newswise

Monday, April 11th, 2022

Newswise The road from discovering a potential drug to getting the therapy into the hands of patients is a long and uncertain one.

Konstantin Petrukhin, Ph.D., ought to know.

In 2011, after years working at the bench, the professor of ophthalmic sciences at Columbia University Medical Center, discovered a promising drug candidate for treating the most common form of age-related macular degeneration (AMD). This blinding eye disease affects millions of Americans, and atrophic or dry AMD accounts for 90% of cases. There is currently no treatment for dry AMD.

The therapy, known as LBS-008 (formerly BPN-14967), appears to be promising for other retinal degenerative diseases such as Stargardt disease, a rare, inherited condition that causes vision loss during childhood and young adulthood.

The cherry on top: Petrukhin identified a biomarker that could easily be measured in a persons blood to confirm the drugs level of activity and fine tune dosage. LBS-008 is a tablet taken by mouth, sparing patients the need for an injection into the eye, which is a common mode of delivery for therapies that must reach the light-sensitive retinal tissue at the back of the eye.

Despite all that LBS-008 had in its favor, Petrukhin had only cleared the first hurdle. The next would involve finding a biopharmaceutical firm willing to take the risk of shepherding the new drug to the market.

For every drug that successfully makes it into the hands of patients, nine fail somewhere along the clinical trial pipeline.[1] On average, it can take up to 15 years and $1 billion to bring a new drug to market, accounting for the failed drug candidates.[2]

Much of that time and money is spent meeting rigorous regulatory requirements established by the U.S. Food and Drug Administration. These requirements are in place to safeguard the health of patients. Before a new drug is FDA-approved, it must demonstrate safety and efficacy in a lengthy three-phase clinical trial process.

And before clinical trials can even begin testing in humans, the FDA requires preliminary support for the safety, efficacy, and quality of the investigational therapy. That means information about the agents performance in preclinical animal studies assessing efficacy and toxicology, detailed clinical protocols and manufacturing plans.

It takes a team of experts with a wide range of expertise to advance a candidate drug to clinical trials, Petrukhin said. Basic science researchers in academia typically do not have access to all the necessary skills to get their novel therapeutics strategies to the point where a biopharmaceutical firm would be interested in taking on a promising drug through the clinical trials process.

For that expertise, Petrukhin turned to the National Institutes of Health Blueprint Neurotherapeutics Network for Small Molecules. Launched in 2011, the network provides a framework for researchers like Petrukhin, who have a promising candidate treatment for an unmet medical need, to attract pharmaceutical company interest.

How the NIH Blueprint program works

The network, which is funded and administered by a consortium of NIH institutes, including the National Eye Institute, provides principal investigators like Petrukhin access to a full range of industry-style drug development services and expertise. Each project forms a lead development team composed of the principal investigator, as well as NIH staff and industry consultants hired by NIH. The network provides principal investigators with access to Contract Research Organizations (CROs) and a team providing cross-functional expertise from assay development and pharmacology to medicinal chemistry, pharmacokinetics, toxicology, formulation development, and Phase I clinical testing.

If a researchers project requires a consultant that has a specific type of expertise such as regulatory affairs or drug manufacturing, we have a diverse group of consultants with years of experience in the pharmaceutical industry who provide guidance in areas such as the FDA regulatory process and the steps involved in developing a useful drug product, free of charge. Essentially, researchers have access to a virtual pharma company tailored to their project through their lead development team and NIH contracts, said Mary Ann Pelleymounter, Ph.D., a scientific project manager for the Blueprint Neurotherapeutics Network for Small Molecules.

Academic and small business researchers are provided with the tools and resources to navigate the drug discovery process in an efficient way that is intended to optimize the probability of success, added Pelleymounter who managed Petrukhins lead development team.

The Blueprint Neurotherapeutics Network was NIHs response to the fact that most nervous system and neurodegenerative disorders lack effective treatment, and most of the potential neurotherapeutic agents identified from basic research do not make it to human testing.

As tough as it is to bring new drugs to market in general, neurotherapeutics have an even steeper hill to climb. They have a long track record of failure and a limited pool of validated treatment targets and strategies on which to build, which resulted in pharma companies exiting the neuroscience research area, said Charles Cywin, Ph.D., program director for the Blueprint Neurotherapeutics Network.

Inherited neurological disorders also tend to affect relatively small populations, which reduces the potential upside for a company taking on the risk.

Finally, neurotherapeutic clinical trials often are expensive because many of the disorders, such as AMD, are neurodegenerative, progressing over years, necessitating lengthy and costly trials to determine if a treatment is working.

The Blueprint Network aims to de-risk candidate therapeutic agents to the point that these projects are attractive investments for pharma, biotech and venture firms, and allows these exciting basic research findings to become potential new drugs to reach patients efficiently, Pelleymounter said.

In 2011, Petrukhins project was selected by the NIH Blueprint Program and received sufficient funding and contract resources to support development of LBS-008 from early discovery through Phase Ia clinical testing.

In 2017, the San Diego-based biopharmaceutical company Belite Bio Inc. (formerly Lin Bioscience) selected LBS-008 for its portfolio to support clinical testing of this candidate therapeutic. By June 2021, the company had launched a late-stage Phase 3 clinical trial of LBS-008 in patients with Stargardt disease. As a potential treatment for a rare disease, testing the drug first in Stargardt enabled LBS-008 to be granted an orphan-drug designation, which qualifies Belite Bio for tax credits and an extended period of market exclusivity after approval. If LBS-008 is approved, it will accelerate the clinical trial process for an atrophic AMD indication.

Under the agreement, Belite Bio holds exclusive global licensing rights. Along with other co-inventors, Petrukhin maintains relevant patents. Columbia University holds the rights to the intellectual property portfolio. If approved, the drug will be marketed as Tinlarebant.

How the LBS-008 therapy works

Petrukhin designed his therapeutic strategy based on a long-observed phenomenon in patients with atrophic AMD and Stargardt disease. Their retinas tend to have an accumulation of lipofuscin, a yellow-brown lipid-based substance associated with aging. Granules of lipofuscin accumulate in a retinal layer called the retinal pigment epithelium (RPE), which supports the health of light-sensing photoreceptors. In both atrophic AMD and Stargardt disease, vision loss occurs when photoreceptors die, but their death happens secondary to the loss of RPE cells. Petrukhin and others hypothesized that reducing harm from lipofuscin might prolong RPE and photoreceptor survival.

The best studied toxic component of lipofuscin is the bisretinoid A2E, a by-product of the normal visual cycle, the vital biochemical pathway that regenerates visual pigment, and is important for converting light (photons) into electrical signals sent from the retina to the brain.

A2E production depends on the influx of retinol from blood to the RPE. Whats more, retinol uptake from blood circulation is dependent on the function of retinol-binding protein 4 (RBP4).

Petrukhin asked whether reducing the retinoid load of the visual cycle with an RBP4 antagonist might reduce A2E production just enough to stave off AMD and Stargardt disease, without interfering too much with the necessary biochemical pathway required for vision.

In his search for a way to inhibit RBP4, Petrukhin came across some papers describing an RBP4 antagonist compound that had initially been developed by the pharmaceutical company Amgen as a potential treatment for diabetes. Long since shelved for diabetes, Petrukhin began tests to see if the RBP4 antagonist might lead to a therapeutic reduction of lipofuscin bisretinoids. That compound (called A1120) was a starting point for optimization that eventually yielded LBS-008, a drug candidate that is currently in clinical development.

In unpublished mouse studies, LBS-008 reduced levels of RBP4 in the blood by 93% after 12 weeks, and A2E levels were reduced by 80% in treated mice compared to controls.

Furthermore, in mouse models of Stargardt disease, compared with controls, LBS-008-treated animals had significantly greater preservation in the thickness of their outer nuclear layer, a cell layer that consists of photoreceptors that becomes thinner with disease-related damage.

Petrukhin notes that several other companies have since adopted similar RBP4 antagonist strategies for reducing lipofuscin bisretinoids. So, the field has become very crowded, which tells we made the right choice, he said.

Today, Petrukhins lab is continuing to explore optimal strategies for developing the next generation of RBP4 antagonists, which are not only potential therapies for eye diseases, but may also be used as a treatment for metabolic diseases such as non-alcoholic fatty liver disease and type 2 diabetes.

Building on the success of the initial Blueprint Neurotherapeutics Network for Small Molecules (that is, therapies like Petrukhins that enter cells and work at a molecular level), the program recently expanded to support lead optimization for biologic therapies, which are treatments derived from substances made from living organisms.

This is an exciting new opportunity for vision scientists working on some of the most promising biologic-based therapies, such as gene therapies, or cell-replacement therapies, said Thomas Greenwell, Ph.D., a program director for the NEI and for Blueprint. To learn more about the Blueprint Neurotherapeutics Network: Biologic-based Drug Discovery and Development for Disorders of the Nervous System, visit https://neuroscienceblueprint.nih.gov/neurotherapeutics/bpn-biologics

Clinical trials testing LBS-008, also known as BPN-14967 are NCT05244304, NCT04005807, NCT05266014, NCT03735810.

Links

Blueprint Neurotherapeutics Network (BPN) for Small Molecules

Age-related macular degeneration

Stargardt disease

Safety and Tolerability Study ofLBS-008in Healthy Adult Subjects After Single and Multiple Doses on Clinical Trials.gov

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Knight Campus talk to focus on the cornea and vision science – AroundtheO

Monday, April 11th, 2022

Bala Ambati, an ophthalmologist and research professor in the Phil and Penny Knight Campus for Accelerating Scientific Impact, has seen a lot over the course of his 25-year career.

A leading eye surgeon, vision science pioneer and medical missionary, he has helped repair or restore vision to countless patients around the world, and researchers in his lab in the Knight Campus continue to develop treatments to prevent or reverse blindness, provide clearer vision and reduce the need for corneal transplants.

Ambati will focus on the cornea, the window to the eye, and provide an overview of the history of vision science, as the featured speaker at Science Knight Out, a community science talk sponsored by the Phil and Penny Knight Campus for Accelerating Scientific Impact.

RSVP online to the virtual event, slated for 4 p.m. Thursday, April 14.

Ambatis talk, Eye on the Cutting Edge: Healing the Window on the World, will highlight research from his lab, including a new gene therapy that could eventually provide an alternative treatment for Fuchs endothelial corneal dystrophy, a genetic eye disease affecting roughly one in 2,000 people globally. Currently, the only treatment is corneal transplant, a major surgery with associated risks and potential complications.

An ophthalmologist at Pacific Clear Vision Institute in Eugene, Ambati will also explore some of the breakthroughs in vision science over the past 20 years. In addition to performing thousands of cataract surgeries, LASIK and other vision correction procedures, he has alsoserved as a volunteer eye surgeon in Ghana, Zambia, India, Panama, Indonesia, the Philippines and Malaysia.

I love having the ability to take care of my patients and to help them see, Ambati said. I also love the ability to work with a fantastic group of people here at the Knight Campus and in my lab to come up with the next generation of cures and treatments to help patients around the world for years to come.

A visionary researcher and highly regarded clinician with an entrepreneurial drive, Ambati co-founded iVeena, a startup focused on developing an eyedrop for corneal strengthening and an implant for drop-free cataract surgery. Prior to joining the Knight Campus in July 2020, he completed his residency at Harvard University and a fellowship at Duke University.

Hehas been in practice 17 years as a cataract, cornea and refractive surgeon. He was director of cornea at Medical College of Georgia for five years and most recently was professor and director of cornea research at the University of Utah. Having graduated at 17 from Mount Sinai School of Medicine as the worlds youngest doctor, he was cited in 2015 as the No. 1 eye surgeon in a top 40 under 40 global competition and made the Top 100 Power List of Ophthalmology by The Ophthalmologist magazine.

Ambati has been recognized for his teaching excellence with a University of Utah Resident Research Mentor Award and the Gold Humanism Award. He servedas an instructor at the Harvard Cataract Course.

Ambatis talk will mark the sixth installment of Science Knight Out lecture series, which dates to 2017.

Past events were headlined by Leslie Leve, associate director of the UOs Prevention Science Institute; Robert E. Guldberg, vice president and Robert and Leona DeArmond Executive Director of the Knight Campus; Patrick Phillips, UO provost and senior vice president; Laura Lee McIntyre, director of the Prevention Science Institute and professor in the College of Education; and David McCormick, director of the Institute of Neuroscience.

Recordings of all past lectures are available on the Science Knight Out web page.

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Diabetic Patients with Rosacea at Increased Risk of Ocular Disease – MD Magazine

Monday, April 11th, 2022

A new database study found that patients with diabetes and rosacea were at a significantly higher risk of diabetic macular edema, glaucoma with medical treatment, dry eye disease, and cataract surgery compared to patients without rosacea.

In previous research, rosacea has been associated with a variety of systemic comorbidities including gastrointestinal, cardiovascular, neurologic, psychiatric, and metabolic diseases.

Diabetes has also been associated with several ocular diseases, with previous research suggesting a systemic inflammatory component. Though the role of inflammation in diabetic eye diseases has been studied, no research has been conducted regarfing ocular complications in patient with diabetes due to rosacea.

Investigators led by Chau Yee Ng, MD, Chang Gung Memorial Hospital, Taiwan, detailed the association between rosacea and eye diseases in patients with diabetes via a retrospective cohort nationwide study.

Ng and colleagues included all patients diagnosed as having diabetes mellitus who received hypoglycemic agents between January 1, 1997, and December 31, 2013.

A total of 2,099,303 patients were identified, 5459 of whom had been diagnosed with rosacea. After applying exclusions criteria, 4096 diabetic patients with rosacea were matched 1:4 with 16,384 diabetic patients without rosacea.

From there, investigators compared the risk of time-to-event outcome between rosaces and non-rosacea groups in the propensity score matching cohort using the Fine and Gray sub-distribution hazard model.

Following a mean follow-up period of 5 years, investigators observed that patients with diabetes and rosacea had significantly higher risks of diabetic macular edema (sub-distribution hazard ratio [SHR]: 1.31, 95% CI: 1.05-1.63), glaucoma with medical treatment (SHR: 1.11, 1.01-1.21), dry eye disease (SHR: 1.55, 1.38-1.75), and cataract surgery (SHR: 1.13, 1.02- 1.25) compared with patients without rosacea.

Additionally, the team observed a significant association between psoriasis, irritable bowel syndrome, anxiety, and depression in patients with diabetes and rosacea compared to patients without rosacea.

In this retrospective cohort nationwide database study, diabetic patients with rosacea had significantly higher risks of diabetic macular edema, glaucoma with medical treatment, dry eye disease, and cataract surgery compared with patients without rosacea, the team wrote. This is the first study demonstrating the association.

The findings were presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston.

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Medical Musings: The growing prevalence of Lyme Disease – Daily Press

Monday, April 11th, 2022

While walking in a grassy or wooded area, there is an increasingly prevalent infectious disease that can be contracted from the bite of an unseen tick.

Annually, half a million people in the United States develop Lyme disease. Over the last two decades, there has been a sharp rise in both the number of cases and the geographic distribution of the malady.

The disorders clinical course is variable; the majority of the afflicted have mild symptoms and usually recover after taking antibiotics. In those that are untreated or have a therapeutic failure, complications involving multiple organs systems may ensue; it can last from months to years. The condition is rarely fatal.

Lyme disease is caused by the spirochete bacterium borrelia burgdorferi that is transmitted to humans through the bite of an infected black-legged tick, commonly known as a deer tick.

While the ailment is primarily observed on the East Coast, it has been reported in all states except Hawaii. The disorder can occur in any season but is most common from May to August.

Only a minority of tick bites lead to an infection. The longer the insect remains attached to the skin, the higher the threat of getting the disorder. If affixed less than 36-48 hours, the risk of contracting the illness is greatly reduced.

Once the bacteria enter the blood stream, the pathogens spread throughout the body. Feeling ill stems from the immune systems response to the microorganisms in various tissues and organs.

Untreated individuals go through several stages with different clinical characteristics in each phase that frequently overlap.

During the initial manifestations, flue-like symptoms of fever, chills, body pain, headaches, neck stiffness and swollen lymph nodes occur. These indices are associated with a distinctive rash (erythema migrans) that develops 3-30 days after an infected tick bite.

This skin eruption which appears as a bulls eye is annular, reddish, with or without a central clearing and neither itchy nor painful. It expands slowly and can spread up to 12 inches. Up to 30% of those infected may not form a rash, or its presence was overlooked.

If you notice a tick on you but dont develop the telltale bulls-eye-shaped rash, dont assume that youre in the clear; its still possible to develop Lyme disease. Be on the lookout for symptoms including fever, chills and aches and pains, and if you notice any, go to the doctor immediately.

In those with untreated disease and a small subset of victims with treatment failure, serious more broadly distributed findings can appear. These include facial palsy, meningitis, cardiac abnormalities, severe joint pain, arthritis and eye inflammation.

An early diagnosis can be a difficult task.

An article in Frontiers of Medicine notes that outside of the diseases nascent ruddy rash, proof of the disorder relies on non-specific clinical signs that in the initial stages may not be supported by laboratory data.

A delay in confirmation of the condition occurs in upwards of 40% of those ultimately diagnosed. Frequently these individuals will have advanced clinical findings as a consequence of the stalled recognition of the malady.

One explanation for the lag in diagnosis is that many who have been exposed to ticks often ignore non-specific symptoms particularly when there is an absence of a rash. They do not seek timely medical advice.

For those with classic clinical findings, doctors can make the diagnosis with near certainty when an expanding bulls eye red rash is present. For the less-apparent cases, a combination of a history of tick exposure, physical exam and blood tests to detect antibodies can usually confirm the diagnosis.

Humans have been inflicted with the tick-borne bacteria since ancient times.

The oldest known case was documented in a 5,300-year-old iceman found in a glacier in the Italian alps. Closer to the present, in Colonial America there were many early settlers who suffered from Lyme-like symptoms. An abundance of ticks dwelled in the forests in the northeastern colonies. The diseases modern moniker emanated from the town of Lyme, Connecticut, where the disorder was documented in the 1970s.

Unlike in the 17th and 18th centuries, preventive measures are known today. These include using insect repellants, wearing light-colored clothing and checking for and safely removing ticks after a walk. When these precautionary measures fail, and one is faced with the diagnosis of LD, effective treatment is available for most cases.

The earlier the therapy begins, the better the prognosis.

Antibiotics are the definitive medications for Lyme disease. When more advanced symptoms are present, the drug is continued for a longer period. For those with post-treatment reoccurrence, there is less of a consensus as to the treatment regimen for this poorly understood subsegment of the disorder.

While there are ongoing investigations for new therapeutic modalities, a safe and efficacious vaccine has become a priority.

Historically, a Lyme disease vaccine for adults was approved by the FDA in the late 1990s, but it was withdrawn in 2002 by the manufacture because of the limited response in the marketplace. Currently, a vaccine has renewed research attention; there are some promising products in the preclinical phase.

Lyme disease is not only a human disorder its common in mans best friend.

Veterinarians in endemic areas are familiar with the afflictions symptoms, diagnosis and treatment for their tic-prone furry patients. The clinical signs are largely non-specific in dogs; the humans signature bulls eye lesion does not develop. The treatment process generally mimics the same approach as with humans, except for canines there are commercially available vaccines. Lucky dogs!

While the infection cannot be directly transmitted from a pet to a human, an outside dog or cat may act as a carrier and bring a tick hidden in its fur into a home; once inside, it could bite a human.

While scientists continue working to unravel the mysteries of Lyme disease, remember, when out for a walk in a grassy field, infected ticks are eagerly waiting on the tips of vegetation ready to crawl onto a person or dog and then find a place to bite. Take precautions.

Dr. Jonathan L. Stolz is a retired physician and author of the book Medicine from Cave Dwellers to Millennials.

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Regular eye examinations, are key to early stage disease detection: Dr Girish Rao – Times of India

Monday, April 11th, 2022

The retinal disease burden in India is on the rise. While 35% of the Indian population needs some form of vision correction only 25% of those have had their vision corrected. This is mainly since retinal diseases can go unnoticed for a long time, as some have no symptoms at first. A comprehensive eye exam by a retina specialist or ophthalmologist is necessary to find these diseases in the early stages, when treatment to prevent vision loss is most effective.

Eye examinations includes test visual acuity, depth perception, eye alignment, eye movements and eye pressure measurement. Eye drops are used to make your pupils larger so your eye doctor can examine the retina and also check for signs of health problems. An ophthalmologist may be the first to detect conditions such as high blood pressure or diabetes, sometimes before your primary care doctor does.

Eye Exams: How Often?

Eye checkups are advocated, as a routine, for all children before the age of 5 years and there after once a decade till the age of 40 years. During the presbyopic years it is advisable to have checkup every 2-3 years. Children with glasses need checkup after 6 months till end of schooling. People with specific eye ailments like squint, Glaucoma, Uveitis, retinopathies require closer follow-ups as advised by the ophthalmologist. People with diabetes should have a dilated eye exam every year.

Better managing eye health

The most important step in an eye disease treatment is its early diagnosis. The patient must adhere to the four-point vision loss prevention program that includes regular eye examination, good control on your diet, a healthy lifestyle, and keeping an eye on vision problems.

In a similar manner, diabetic patients are required to monitor their blood sugar levels. Keeping a regular check on their diet, post-lunch sugar levels, and following doctors advice can help maintain the ideal HbA1c levels. Antidiabetic medicines coupled with lifestyle modifications such as, a healthy diet plan, exercising, and smoking cessation is the path towards efficiently managing diabetes. It is key to manage diabetes to halt the eye diseases that come with the territory.

A diabetic patient is simultaneously required to be a key observer of their vision aberrations. If vision suddenly changes or becomes blurry, spotty, or hazy, contacting an ophthalmologist immediately will prove beneficial. Ensuring an early detection of Diabetic Retinopathy & Diabetic Macular Edema, and an early diagnosis allows effective treatment and prevents complications like irreversible vision damage. A regular eye check-up is crucial for a diabetic to avoid any delay of treatment and hence vision loss.

Vision care beyond treatment

The technological and medical advancements today have brought in a number of treatment options that can be availed, such as focal laser treatment, anti-VEGF injections, surgery etc. Whats important is to understand and adhere to regular check-ups. Visiting the doctor every 6 months allows the patient and doctor to catch the condition in its early stages and find an accurate treatment for it. Ensuring a regular contact with the eye doctor to find correct medication, treatment options, treatment process, and care should be a priority for the patient. Treatment helps immensely, but following up on scheduled appointments, ensuring that your eye health doesnt derail again is equally important.

The COVID pandemic had a devastating effect of the health of the people worldwide. The repeated long periods of lockdowns, reduced access to healthcare facility and restricted transport resulted in majority of patients with co-morbidities not seeking medical aid at an appropriate time. While some were lucky to avoid lasting side-effects to delayed treatment, many had to pay a heavy price for the delay.

Views expressed above are the author's own.

END OF ARTICLE

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UCF Part of Historic Civilian Space Flight to the International Space Station – UCF

Monday, April 11th, 2022

When the first four civilians travel to the International Space Station April 8 they will be working with a team of University of Central Florida doctors to study how space travel affects the human body, particularly the eyes and brain.

Three faculty physicians at UCF Health, the College of Medicines clinical practice, are collaborating with Axiom Space and two Israeli medical centers Sheba Medical Center and Rabin Medical Center to conduct clinical studies with passengers aboard Axioms private flight that will take four passengers to the International Space Station aboard the SpaceX Crew Dragon. The flight is scheduled to launch from the Kennedy Space Center and should return 10-14 days later. The space explorers received pre-flight testing at UCF Health facilities and will be back for post-flight testing.

The eye study will include the use of high-definition technology unlike any used before to examine the participants eye structure. The brain study is the first of its kind in space. These studies represent UCFs first human subject space studies.

Its a historic moment for space exploration with civilians going to the ISS and for UCF, says Deborah German, vice president for Health Affairs and founding dean of the College of Medicine. These two studies are just the beginning. We have several more to come. Its not just about exploring. What we find will contribute to keeping space explorers safe and finding new treatments here at home.

Its All About the Eyes

The first study, a collaboration between Gal Antman, ophthalmologist from Rabin Medical Center in Israel and UCF Health ophthalmologist Mehul Patel, will examine how the microgravity environment of space affects the structure and function of the eye in a condition called spaceflight-associated neuro-ocular syndrome or SANS that typically occurs in astronauts. The most commonly reported symptom of SANS experienced by astronauts is decreased near vision.

In a microgravity setting, one of the theories is that there is fluid buildup and congestion inside of the orbit, which is the bony space in which our eyeballs rest, Patel says. And so, if there is a buildup of fluid even in short duration flights, that exerts pressure on the eyeball which changes how blood enters the eye and leaves the eye and the actual shape of the eye.

The study includes a range of pre-and post-flight eye exams using a noninvasive approach called optical coherence tomography angiography with the comprehensive imaging device called the Spectralis HRA+OCT2 on loan to UCF from Heidelberg Engineering in Germany. This is the first space eye study that will benefit from this kind of detailed imaging.

All prior studies have used MRIs and other ways to image the back of the eye with photos, Patel says. But this newer OCTA technology can be compared to a 4K or 8K TV and those high definition cameras that are allowing you to see greater depth and clarity. So, we can now do something similar in the back of the eye, to really look at detail and definition of blood flow and vascular changes in the back of the eye.

The Brain and Alzheimers

The second study is a collaboration between Professor Yael Mardor and physicians Itzik Cooper and Harel Baris from the Sheba Medical Center, Israel and UCF physicians Joyce Paulson and Ali Rizvi. The study will examine how space travel affects the structure of the blood-brain barrier (BBB). The barrier is a semipermeable coating around the brain that acts as a filter to prevent harmful toxins or pathogens carried in our blood from getting into the brain.

While the barrier has a protective function, it can also filter out or restrict beneficial substances like therapeutic drugs. Researchers are hoping the barrier can be altered through microgravity to allow better absorption of medications that treat neurodegenerative diseases, like Alzheimers.

The civilian astronauts will undergo pre- and post-flight evaluations (including MRIs) to see if there are changes in the BBB.

If there are any changes, Rizvi says, the end goal is to see whether the blood-brain barrier can be temporarily altered by exposing patients to microgravity either in space or simulated on Earth to facilitate the treatment of diseases like Alzheimers.

This is the first blood-brain barrier study to be conducted on human subjects during space travel at the cellular level.

UCF is grateful for this opportunity to collaborate on this project to help enhance the treatment of neurodegenerative diseases, Paulson says. Right now, there are limitations in terms of what we can do to help these patients. Neurodegenerative diseases are not only difficult to treat, but they are also very progressive and impacts not only the patients but their caregivers as well, so studies like these are very important.

The researchers see these studies as an important step in providing new treatments on earth.

The innovative breakthrough in this study lies not only in the specific research questions and methods but in the creativity of referring to the physiological impacts of exposure to microgravity as holding a therapeutic potential- which holds a promise for harnessing space endeavors to other medical applications and healthcare innovation, says Baris, director of the ARC Space Lab at Sheba Medical Center. We are confident that the collaborations on these studies will pave the way for further shared efforts and enable our clinicians to provide better healthcare, for all human, either in space or on Earth.

Sheba Medical Center is the largest hospital system in Israel and Newsweek has ranked it in the top 10 internationally.

Israeli astronaut Eytan Stibbe has completed all pre-flight testing and will return for post-flight testing at UCF Healths Medical City location and UCF Lake Nona Hospital, the medical schools partnership hospital with HCA Healthcare.

I am excited to be able to participate in these research studies and contribute to medical knowledge for future generations, Stibbe said as he began testing at UCF days before being quarantined before the flight.

The UCF-affiliated studies are just two in of many experiments being conducted during the mission.

The UCF College of Medicines Department of Clinical Trials, under the direction of Amoy Fraser, is leading the trials. Fraser says more space flights studies are under negotiation.

The medical schools research expertise and its Medical City location , close to an international airport and the space center make us an optimal partner for medical space research, Fraser says.

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Fenofibrate Use May Reduce Progression to Vision-Threatening Diabetic Retinopathy – MD Magazine

Monday, April 11th, 2022

New findings suggest fenofibrate use was associated with a decreased risk of progression from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) and vision-threatening diabetic retinopathy (VTDR), but not diabetic macular edema (DME) alone.

Additional clinical trials may be necessary to determine if these associations are representative of a causal relationship between fenofibrate use and reduced risk.

Our positive association for progression to PDR coincides with results of previous clinical trials and adds new information with regards to the impact on DME, wrote study author Brian L. VanderBeek, MD, MPH, MSCE, Scheie Eye Institute.

Previous research including the ACCORD-EYE study showed reduced progression of diabetic retinopathy severity, but did not address the thresholds of DME or PDR. In contrast, the FIELD study showed reduced laser treatment of DME and PDR with fenofibrate use, but mixed results in the overall progression of diabetic retinopathy.

Accordingly, there is interest in the potential role of fenofibrate in diabetic retinopathy care, with ongoing randomized clinical trials taking place through the DRCR Retina Network.

The current study aimed to further assess the association between fenofibrate use with diabetic retinopathy progression using medical claims of all beneficiaries in a commercial and Medicare administrative database.

Study cohorts were created from all patients with NPDR 18 years or older from who had laboratory values from January 2002 - June 2019. Criteria for exclusion consisted of any previous diagnosis of PDR, DME, proliferative vitreoretinopathy, or treatment used in the care of VTDR.

The main outcomes were identified as a new diagnosis of VTDR or DME and PDR individually, defined by International Classification of Diseases or Current Procedure Terminology codes. Additionally, a time-updating model for all covariates was used in multivariate Cox proportional hazard regression to determine the hazards of progressing to VTDR.

Investigators included a total of 5835 fenofibrate users at baseline with a mean age of 65.3 years (3564 [61.1%] male patients; 3024 [51.8%] White patients) in the analysis. Moreover, they included 144,417 fenofibrate nonusers, with a mean age of 65.7 years (73,587 [51.0%] male; 67,023 [48.4%] White) in the analysis.

In the observation period, data show 27,325 (18.2%) patients progressed to VTDR, 4086 (2.71%) progressed to PDR, and 22,750 (15.1%) progressed to DME.

After controlling for covariates, Cox model results showed the association between fenofibrate and a decreased risk of VTDR (hazard ratio, 0.92 [95% CI, 0.87 - 0.98]; P = .01) and PDR (hazard ratio, 0.76 [95% CI, 0.64 - 0.90]; P = .001).

However, no association was observed on development of DME (hazard ratio, 0.96 [95% CI, 0.90 - 1.03]; P = .27).

Our findings offer further hope that the DRCR Retina Network clinical trial will prove beneficial for progression to PDR but some concern for those who are hoping for reduction in DME incidence, VanderBeek concluded.

The study, Association of Fenofibrate Use and the Risk of Progression to Vision-Threatening Diabetic Retinopathy, was published in JAMA Ophthalmology.

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Beyond the Wall: Eye-opening visit to U.S.-Mexico border | Faith Matters – NJ.com

Monday, April 11th, 2022

PART 1: Life and struggles of migrants, aid workers

Driving an hour from the Tucson, Arizona, airport to the Mexican border, you go through miles of mountains and desert that in the dead of winter appear dark and ominous. Occasionally you see signs for a town -- Rio Rico, Patagonia, Tubac carved out of the terrain.

But for the hundreds of thousands of migrants from Central America and Mexico stuck in the state of Sonora, Mexico, the desert is often the only way out and into the U.S. And it can be treacherous.

In mid-February, I spent a week in Nogales, Arizona, with Jesuits who run the Kino Border Initiative in the other Nogales, across the border in Sonora.

Jesuit seminarian Kieran Halloran, 29, who just left St. Peters Prep in Jersey City after two years of teaching, is spending his third year of regency, or apostolic work, at Kino working with migrants. Reading and hearing so much about issues at the border, I decided to visit him and see for myself.

The suffering and desperation along with the daily heroism of those devoted to help -- are real and ever-present.

As an example, at dinner with the Jesuit community in Arizona one evening, seminarian Victor Yanez received a phone call from a border rescue group that they were on their way to retrieve a man from Mexico who was trying to get into the U.S. and became disoriented.

Nighttime temperatures in the desert are cold and although the stars are so bright you think you can reach up and grab one, the sky is very dark. The migrant was lucky his cell phone worked and he could reach his family, who called the rescue operation, and that they could locate him.

He was also lucky he survived; many do not. Bodies and bones, KBI staff told me, are routinely discovered in the desert. Against the wishes of the U.S. Border Patrol, activists regularly traipse through the desert in daylight and leave jugs and bottles of water along with blankets in what appear to be some well-traveled paths so migrants would have some relief.

But providing relief has become a monumental task.

In the last 40 years, the U.S. government has been tightening immigration policies and millions of migrants, even those seeking asylum for life-threatening situations, have found themselves in limbo at the border. Then-President Trump, through White House immigration adviser Stephen Miller, enacted harsh measures, including Title 42, which requires that migrants seeking asylum remain in Mexico until their cases are heard, which could take months or years. Perhaps as many as 200,000 people hoping to immigrate to the United States remain in the Nogales, Mexico, vicinity.

On April 1, the Biden administration announced plans to finally end Title 42 restrictions starting May 23.

More welcome news had come last month when the Biden administration announced a new policy through which some migrants seeking asylum will have their claims heard and evaluated by asylum officers instead of immigration judges, cutting down the massive backlog of applications.

More than two-thirds of the 11,015 migrants who arrived at KBI last year reported violence or persecution as the main reason for migrating, the organization reports.

And the harshness of life on the Mexican side of Nogales was chronicled in a remarkable 2021 book, Voices of the Border (Georgetown University Press), edited by Tobin Hansen and Sister Maria Engracia Robles, KBI Mexicos director of education.

Robles is the superior of the Missionary Sisters of the Eucharist in Sonora and spent years listening to and transcribing migrants stories of wanting a better life but being stymied by U.S. policies going back to the 1980s. While Trump was a megaphone for hate, even President Obama was deporting people at record numbers.

Maras, or gangs, rule much of Mexico and they demand payment to escape via train. But once on the train, migrants are targeted again for hundreds of U.S. dollars, which most do not have, to continue the journey. Those who refuse or cannot pay would be thrown off into the train tracks, decapitated or attacked with a machete, the VOB book detailed.

From 1998 to 2020, the authors write, more than 7,500 people lost their lives while attempting to cross the treacherous U.S.-Mexico border due to heat stroke, dehydration, hyperthermia and drowning.

Some have been killed in incidents with Border Patrol. On the Mexican side of the border, Halloran and I stopped by a huge painting of 16-year-old Jose Antonio Elena Rodriguez, who was shot and killed 10 years ago by a USBP agent who fired into Mexico from the American side. The agent claimed the boy threw rocks at him, putting the agents life in danger. Mysteriously the camera video disappeared and the agent was acquitted of murder at trial in Tucson.

FLEEING VIOLENCE

Among the 50 migrants in the shelter when I was there were people from Central American countries fleeing gang violence and threats on their lives. KBI protects them while providing legal aid to expedite their asylum claims.

The seriousness of their situations is evident in the fact that the new KBI building, open since 2020, has no outdoors space where the shelter residents can go out in the sun even though there is endless land around it. On the land adjacent, men who appear to be squatters wander. Yanez calls them the Mafia, who spy on people coming to and from the border crossing and are part of an underworld of people who take advantage of desperate migrants.

As a priest, I had free reign at the shelter but as a journalist could not interview the migrants there. KBIs policy is not to revictimize the migrant, said Yanez.

We work with each migrant how to tell his or her story in a fashion that looks toward the future, he told me.

That is the role of Gia Del Pino, 31, KBI director of communications for the last eight months.

Migrant justice is my calling, said the Ph.D. candidate at the University of Arizona in Tucson, a beautiful campus I visited. She is a child of Cuban and Venezuelan immigrants.

My closest contact to these protected migrants was sitting in on the ESL classes given by Sister Marlita Henseller in a back section of the shelter. Shes on a one-year sabbatical volunteering at KBI. A Wisconsin Franciscan Sister of Christian Charity for 58 years, she represents for me the best of the hundreds of women religious I have met in my years as a priest. They started out as school teachers or working in Catholic institutions but then embraced the Vatican II spirit to get out into the world and minister to the poor.

Henseller learned Spanish in Bolivia over five months and then served as a missionary in Peru for 12 years.

Wanting to go to Sonora, she said, I told my provincial I wanted to hug Spanish babies. And surely her warm, friendly style embraces migrant women and children as she guides them to learn English.

The mothers are young, but their children seem to pick up the English quicker. Sometimes, the younger children are restless and distract the group, but Sister takes it in stride and shows humor.

The international charity Save the Children staffs a large, colorful education center at KBI and works with the children to keep up with studies and also provide them with some activities.

COMEDOR

While KBI now has many components, it is commonly referred to as the comedor, or dining room, after its initial mission to feed migrants.

As soon as you enter the large central space, your eyes are drawn to a huge mural of the Last Supper on the far wall, a painting of actual KBI migrants, staff and volunteers done by Wenceslao Hernandez, a migrant who has established himself as a Sonora, Mexico, artist. Its so realistic you think it is a photo, but it also captures what continues to be KBIs main mission: feeding the hungry.

On any given day pre-pandemic, KBI would serve anywhere from 100 to 900, estimated Joanna Williams, 30, executive director for the last year, though employed there for seven.

The current building opened Feb. 12, 2020, right before COVID closed it down, and it has slowly been building up its clientele and services. Food service is now to-go.

My first day there I was part of the morning food serving team dishing out string beans mixed in with scrambled eggs and then rice, once the eggs were finished.

Henseller checked in the migrants, mostly women with children and some men.

First, soup, then I would be next. They would say in Spanish how many people they would feed that day and I would scoop that number. Then they could have mole, chicken pieces in chocolate sauce. They help themselves to some drink and bread and then go on their way.

Its very eye-opening to see these young mothers with young children following behind them often clinging to their blouse. I asked each child his or her name and made faces at them to make them smile. The special treatment they receive blunts the harshness of daily life they face.

In the month of February, KBI served 8,374 meals. While the number of people they feed now is lower than pre-pandemic, the numbers grow daily.

These migrants are staying in Sonora shelters while their asylum cases are processed, Halloran said.

Without KBI, where would they be able to get as much delicious and nutritious food?

The prep kitchen is always a beehive of activity. After serving, the food for the next days meal is prepped and I was assigned chopping a huge bin of onions along with Kevin Miller, a 28-year-old Californian discerning whether he wants to enter the West Coast province of Jesuits this summer, and Chris Nguyen, 45, a Jesuit seminarian and a regent in campus ministry at the University of California, San Diego.

Four Mexican Missionary Sisters of the Eucharist oversee the kitchen and food prep. They get lots of help from recent college graduates and some gap-year students who spend anywhere from two months to a year living in community in a house nearby in Mexico.

Courtney Smith was next to me on the food serving line. A graduate of Georgetown, the Connecticut native is spending one year at KBI to see the migrant experience first-hand so she can go into work, perhaps in D.C., writing policy for a member of Congress or an immigrant advocacy group.

ADVOCACY

Indeed, advocacy is a big part of KBI mission to promote U.S./Mexico border and immigration policies that affirm the dignity of the human person and a spirit of bi-national solidarity.

To achieve this goal, they provide direct humanitarian assistance, accompaniment with migrants, social and pastoral education, networking to research and transform local, regional, and national immigration policies, according to their website.

In fact, Executive Director Williams credits the decision to end Title 42 in part to the persistence and courage of asylum seekers here in Nogales who have shared their stories and illustrated the suffering that the policy has created.

Yanez, 31, has the job of directing KBIs operations.

A Jesuit regent, who just spent two years at Fordham studying philosophy and also receiving a M.B.A., would typically just volunteer. But his abilities made him suitable to fill a valuable role.

What leaves him completely joyful, he said, is that KBI can provide food and services and allow migrants to acknowledge their own dignity.

He made a coup this year by attracting KBIs first full-time medical doctor. Mexican native Dr. Obed Ruiz, 34, has been a doctor for four years. He sees perhaps a dozen or so migrants each day and said, They have lots of needs.

He treats for dehydration, wounds, blisters and also sees victims of violence. Many, he said, have psychological problems from abuse in so many forms.

The shelter, which accommodates up to 150 individuals, is on the far side of the KBI building. They sleep in bunk beds in several large areas where there are also showers and restrooms. There is also an isolation section for individuals with COVID.

One of the most colorful people I met during my trip was Jesuit Peter Neeley, the superior of the Jesuit community and one of KBIs founders. A Jesuit for 50 years, he reminded me of the many Jersey City Jesuits Ive known, except he wears a cowboy hat and sports a handlebar mustache. Like the Jesuits in Hudson, Neeley came to the order while its 28th Superior General, Pedro Arrupe, moved the Society of Jesus in the late 1960s to live religious life through the prism of social justice.

We moved away from Christ the King to Christ the liberator, Neeley said.

WHO WAS EUSEBIO KINO?

In a way he is a lot like the namesake of the Border Initiative: Eusebio Francisco Kino, from Segno, Tirol, now Italy. The Spanish king in the late 17th century sent this Jesuit priest to evangelize through missions in the Pimera Alta region, now divided between the Mexican state of Sonora and Arizona. Kino was quite successful and even the Spanish military reported to him. Named after Kino is a parkway road, a sports complex and even Kino Springs.

Neeley lives with four seminarians half his age -- Halloran, Yanez, Jarrett Ornelas, who was away while I was there, and Max Landman, 35, a Texas diocesan priest transitioning into the Jesuits. All of them speak Spanish and relate well to each other, sharing in cooking dinner and taking on community tasks. They celebrate daily Mass in a small chapel in their house usually right before dinner.

We are doing what Christ wants, Neeley told me, not to be a prophet, but to live by example.

U.S. Customs and Border Protection vehicles are positioned in Nogales, Arizona, under a pedestrian bridge used by documented commuters. (Rev. Alexander M. Santora photo)

PART 2: All they want is a better life

President Trump used to claim that U.S. border agents supported his draconian immigration policies, and migrants routinely report abuse by USBP. But there are agents, I found, who do their job without malice.

One day, I took a bike ride through downtown Nogales, Arizona, and could not go any further since I reached the elaborate crossing where people, mostly Americans, legally walk to and from Mexico for work. Obviously, they have papers.

During a shift change, I encountered an agent when he disembarked from a USBP van to stretch. He told me he was watching the people exiting on the Arizona side, saying migrants trying to illegally enter the U.S. sometimes dress like commuters and flee into the country.

Hes worked for Border Patrol through three U.S. presidents. He himself is a migrant and now lives a few towns north of Nogales in an upper-middle-class suburb.

He seemed very caring and sensitive. Just that day, he said, he stumbled across a bin of old boots he intended to bring to the job and give to migrants who need them. He knows the agents have a job to do but seemed aware how Trump demonized their work and their image.

Morale is low, he admitted.

I told him I was a Catholic priest and he said he was Catholic and that might have colored what he told me: We feel sorry for the migrants because we know all they want is a better life for their families.

Shops and supermarkets in Nogales, Arizona, have a large selection of Catholic statuary. (Rev. Alexander M. Santora photo)

PART 3: Mexican, Catholic influences strong in Nogales

When I visit a new area, I like to explore the neighborhoods, so I spent several periods during the week walking and biking around Nogales, Arizona. I stumbled on the local library where I could read the Arizona Daily Star and some weeklies.

Nogales has been hit hard by the pandemic with many storefronts shuttered and others trying to hang on. I kept passing a closed store that sold Mexican artifacts. Finally, I found it open, met the owner and learned it is actually a business that sells Mexican items to other businesses for design and decoration.

The owner told me hes been there 23 years and might open a small retail space to attract more customers. Business is bad, he lamented.

Nearby Food City, the equivalent of our Shop-Rite or Acme, has a very popular bakery. Almost all the staff and patrons are Spanish-speaking. As I walked throughout, I noticed that their healthy alternatives, though, were minimal with little choices for no-sugar or low-fat options. But they have two aisles of religious statuary and candles.

Across the street and up the hill is Sacred Heart Church, which I attended on Sunday morning along with about 200 people, again mostly Hispanic.

I later crossed the tracks, which seem to bring freight trains to and from the Mexican border and their box cars seemed endless. It reminded me of what Jersey City had been in its industrial heyday when boats would dock on the Hudson waterfront and trains would transport goods to the heartland.

The Rev. Alexander Santora is the pastor of Our Lady of Grace and St. Joseph, 400 Willow Ave., Hoboken, NJ 07030. Email: padrealex@yahoo.com; Twitter: @padrehoboken.

See the rest here:

Beyond the Wall: Eye-opening visit to U.S.-Mexico border | Faith Matters - NJ.com

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