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Opportunities in the Global Induced Pluripotent Stem Cell (iPS Cell) Industry – PRNewswire

August 13th, 2020 7:54 pm

DUBLIN, Aug. 11, 2020 /PRNewswire/ -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report" report has been added to ResearchAndMarkets.com's offering.

Since the discovery of induced pluripotent stem cells (iPSCs) a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs have surged in recent years. 2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration. In another world-first, Cynata Therapeutics received approval in 2016 to launch the world's first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. Numerous physician-led studies using iPSCs are also underway in Japan, a leading country for basic and applied iPSC applications.

iPS Cell Commercialization

Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand. iPSC cell applications include, but are not limited to:

Since the discovery of iPSC technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. The main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies, and clinical trials for the development of iPSC-based therapeutics.

Key Topics Covered:

1. Report Overview

2. Introduction

3. History of Induced Pluripotent Stem Cells (IPSCS)

4. Research Publications on IPSCS

5. IPSCS: Patent Landscape

6. Clinical Trials Involving IPSCS

7. Funding for IPSC

8. Generation of Induced Pluripotent Stem Cells: An Overview

9. Human IPSC Banking

10. Biomedical Applications of IPSCS

11. Other Novel Applications of IPSCS

12. Deals in the IPSCS Sector

13. Market Overview

14. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/kpc95y

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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Mallinckrodt Announces U.S. FDA Filing Acceptance of Biologics License Application for StrataGraft Regenerative Skin Tissue for Treatment of Adults…

August 13th, 2020 7:54 pm

- StrataGraft Skin Tissue, If Approved, Could Reduce or Eliminate the Need for Autografting of Healthy Skin to Treat Burn Wounds -

STAINES-UPON-THAMES, United Kingdom, Aug. 10, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date ofFebruary 2, 2021.

Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns.1 The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), expressed interest in StrataGraft skin tissue asa medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.

"Treatment advances are needed that can help minimize or eliminate the need for autografting. The FDA's acceptance of the BLA submission for StrataGraft skin tissue for review takes us one step closer to providing adult burn patients in the United States with a potential new treatment option for deep partial-thickness thermal burns," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are focused on delivering solutions to patients with severe and critical conditions, and look forward to working with the FDA during the regulatory review process for StrataGraft skin tissue."

The StrataGraft skin tissue BLA is based on data from the pivotal Phase 3 STRATA2016clinical trial, previously publishedas an abstract in the Journal of Burn Care & Research and presented via a prerecorded video at the virtual American Burn Association 52nd Annual Meeting, with support from the STRATA2011clinical trial, previously published in Burns. Top-line results from the Phase 3 trial of StrataGraft skin tissue, which met both primary endpoints in adults with deep partial-thickness thermal burns, including autograft sparing and durable wound closure, were announcedin September 2019.

The completion of the BLA rolling submission was announcedon June 9, 2020. The FDA granted StrataGraft skintissue orphan drug designation, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.

About StrataGraft StrataGraft regenerative skin tissue is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer tissue, StrataGraft skin tissue is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled or secured with an adhesive. StrataGraft skin tissue is cryopreserved in order to deliver viable cells upon application.

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Mallinckrodt is currently conducting a StrataGraft skin tissue continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP). The trial sites involved in the pivotal Phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this multicenter, open-label study. The company is planning to evaluate StrataGraftskintissue for the treatment of adults with full-thickness burns (also referred to as third-degree burns). Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in treatment of pediatric populations.

StrataGraft skintissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.

The continued development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and the BLA process for StrataGraft skin tissue in the United States, is being supported through a partnership with BARDA, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA's strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and at-risk populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.2The limited number of specialized burn centers and related medical infrastructure in the United States creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

About Deep Partial-Thickness Thermal BurnsDeep partial-thickness thermal burns are complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin).

Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns. It involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the skin graft to the injury. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of the skin tissue for grafting. Donor site wounds are painful and can create risks of additional scarring and infection. In addition, the amount of healthy skin available for harvesting is frequently limited in those patients with large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Cautionary Statements Related to Forward-Looking StatementsThis release includes forward-looking statements concerning StrataGraft regenerative skin tissue, including the anticipated regulatory review process, its potential impact on patients, and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTS

For Trade Media InquiriesSheryl SeapyW2O 213-262-9390sseapy@w2ogroup.com

For Financial/Dailies Media InquiriesRon BartlettH+K Strategies Senior Vice President813 545 2399ron.bartlett@hkstrategies.com

Investor Relations Daniel J. SpecialeVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Government AffairsMark TyndallSenior Vice President, Government Affairs & Chief Counsel, Litigation202-459-4141mark.tyndall@mnk.com

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

2020 Mallinckrodt. US-2001226 07/20.

________________________1 American Burn Association. Burn Incidence Fact Sheet. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed May 15, 2020.2 United States Government Accountability Office. National Preparedness: Countermeasures for Thermal Burns. https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

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SOURCE Mallinckrodt plc

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Moderna receives $1.525B more in COVID-19 funding from Operation Warp Speed – BioWorld Online

August 13th, 2020 7:54 pm

The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion. The deal, part of Operation Warp Speed, also brings a U.S. government option to buy up to an additional 400 million doses from Moderna. The implied price per dose is about $15.25, below SVB Leerinks $22 price per dose model from previous Moderna-Operation Warp Speed deals. On July 27, Moderna dosed the first of what could be as many as 30,000 healthy volunteers as it began its phase III COVID-19 vaccine trial. Those volunteers at increased risk of contracting COVID-19, with a large percentage being elderly or people with co-morbidities those most at risk for life-threatening COVID-19 infections are receiving placebo or mRNA-1273.

Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the infections themselves, theres one point of agreement: the pandemic has been a painful experience that everyone needs to learn from. Im hoping that memory is not short, Mike Piccarreta, a partner at global consulting firm Kearney, told BioWorld. Clearly we were not prepared for this type of pandemic in terms of government response and manufacturing capacity, he added. Had the U.S. and other countries acted on lessons that should have been learned in the past, they would have been better prepared for COVID. And if they allow the current lessons to fade with time, they will not be ready for the next pandemic.

LONDON Antifungal specialist F2G Ltd. has closed a $60.8 million round, providing the means to complete phase III development of the lead product olorofim, a treatment for life-threatening invasive infections, and to scale up in preparation for commercialization. Olorofim is the first of a new class of drugs called orotomides, discovered and developed to phase IIb by F2G. If approved, it will be the first new antifungal based on a novel mechanism in nearly 20 years.

A bid by top shareholders and managers of the U.S.-China cell therapy developer Cellular Biomedicine Group Inc. to take the company private pushed shares (NASDAQ:CBMG) 35% higher Wednesday, just shy of the offering price. "As a private company, we will have access to the resources and long-term commitment needed to better pursue new capital investment in existing assets and targeted acquisition opportunities as our sector continues to evolve, including further geographic and product diversification," CBMG's CEO Tony Liu told employees.

As part of its earnings report earlier this week, Reata Pharmaceuticals Inc. provided a regulatory update that caused some chagrin among investors. The company said the FDA is not convinced that the Moxie Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results. A phase II study with omaveloxolone for Friedreichs ataxia, Moxie Part 2 had gained the agencys sign-off regarding its primary endpoint; improvement on the modified Friedreich Ataxia Rating Scale. Reata said an NDA submission is now targeted for the first quarter of next year, assuming regulators accept the trial design of the companys planned crossover study. The company provided more encouraging news about the progress of bardoxolone in Alport syndrome. Shares (NASDAQ:RETA) took a hit Monday, dropping from $156.20 to $105.40, and were trading midday at $103.09.

Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively. Launched on Aug. 11, Lianbio was founded, seeded and incubated by hedge fund Perceptive Advisors with the aim of bringing in first-in-class drugs. Perceptive will help the startup pick assets that have a good chance of becoming clinically successful.

PERTH, Australia Aussie regenerative medicine company Regeneus Ltd. has out-licensed its lead mesenchymal stem cell and secretome therapy, Progenza, to Japans Kyocera Corp. for osteoarthritis of the knee for the Japan market. Under the terms of the deal, Regeneus will receive $19 million in up-front and milestone payments, consisting of $9 million up front and $10 million in regulatory and development milestones. Regeneus will also receive double-digit royalties on sales. The company retains rights to negotiate licenses with other partners for additional indications inside and outside of Japan.

HONG KONG Singapore-based Tessa Therapeutics Pte Ltd. released the results of two independent phase I/II trials led by Baylor College of Medicine and the University of North Carolina Lineberger Comprehensive Cancer Center. It was found that Tessas autologous CD30 CAR T-cell therapy (TT-11) showed a high rate of durable complete responses and a very favorable safety profile in patients with relapsed/refractory Hodgkin lymphoma.

Adverum, Akari, Arca, Ascendis, Azurrx, Beroni, Blade, Boehringer Ingelheim,Botanix, Cellular Biomedicine, Cytovia, Eli Lilly, Eloxx, Epirium, Eyegate, Genscript, Helix, Hepion, Horizon, Ikena Oncology, India Globalization Capital, Inhibrx, Innovent, Kahr Medical, Kineta, Monopar, Nektar, Nicox, Nymox, Omeros, PDL, Pliant, Redhill, Regeneron, Sapience, Seattle Genetics, Seres, Theranexus, Therapeutic Solutions, Trevena, Vaccibody, VBL

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NIH names Dr. Rena D’Souza as director of the National Institute of Dental and Craniofacial Research – National Institutes of Health

August 13th, 2020 7:53 pm

News Release

Thursday, August 13, 2020

National Institutes of Health Director Francis S. Collins, M.D., Ph.D., has selected Rena N. DSouza, D.D.S., M.S., Ph.D., as director of NIHs National Institute of Dental and Craniofacial Research (NIDCR). A licensed dentist, Dr. DSouza is currently the assistant vice president for academic affairs and education for health sciences at the University of Utah, Salt Lake City. There she also serves as a professor of dentistry, the Ole and Marty Jensen Chair of the School of Dentistry and professor of neurobiology and anatomy, pathology and surgery in the School of Medicine and the Department of Biomedical Engineering. She is expected to begin her new role as the NIDCR director later this year.

Dr. DSouza is renowned for her research in craniofacial development, genetics, tooth development and regenerative dental medicine. She has worked as a proponent for NIH for decades, serving on critical advisory committees and as an expert consultant on multiple projects, said Dr. Collins. I look forward to having her join the NIH leadership team later thisyear. I also want to thank NIH Principal Deputy Director Lawrence A. Tabak, D.D.S., Ph.D., for his valuable leadership as the acting director of NIDCR since January 1, 2020.

As NIDCR director, Dr. DSouza will oversee the institutes annual budget of over $475 million, which supports basic, translational and clinical research in areas of oral cancer, orofacial pain, tooth decay, periodontal disease, salivary gland dysfunction, craniofacial development and disorders and the oral complications of systemic diseases. The institute funds approximately 770 grants, 6,500 researchers and 200 organizations. Additionally, NIDCR supports research training and career development programs for approximately 350 people at various stages of their careers, from high school students to independent scientists.

Dr. DSouza has been a principal investigator on multiple NIH and other federal grants since 1987 and has published 140 peer-reviewed journal papers and book chapters. Her research focuses on developmental biology and genetics; matrix biology; biomaterials, tissue engineering and stem cells; and clinical research. Her groups discovery that a novel mutation in PAX9 was responsible for a severe form of human tooth agenesis opened a new field of research to discover genes and mutations as well as therapies for common human inherited disorders of the craniofacial complex.

Dr. DSouzas career honors are significant. She was selected to be the inaugural dean of the University of Utahs School of Dentistry, which was established in 2012. She is currently the elected chair in Dentistry and Oral Health Sciences Section and elected as a fellow of the American Association for the Advancement of Science. She also is a former president of the American Association for Dental Research and the International Association for Dental Research,a fellow of the American College of Dentistsand the recipient of the 2017 American Association for Dental Research Irwin D. Mandel Distinguished Mentoring Award. Dr. DSouza served on the NIH Advisory Committee to the Director in 2013-14, and on NIH study sections. She is a devoted mentor and champion of diversity in the biomedical research workforce. Since 1985, she has served as a volunteer dentist for women in need and people struggling with homelessness in Salt Lake City, Dallas and Houston.

Dr. DSouza received her bachelors degree in dental surgery from the University of Bombay, India, after which she completed her general practice residency. She earned her D.D.S., Ph.D. and masters degree in pathology/biomedical sciences from the University of Texas Health Science Center in Houston.

NIDCR is the nations leading funder of research on oral, dental, and craniofacial health. To learn more about NIDCR, visit https://www.nidcr.nih.gov/.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Parents worry too much screen time will have an adverse affect on children’s vision – Wink News

August 13th, 2020 7:52 pm

FORT MYERS

With online learning, most kids are experiencing an increase in screen time, and that can mean tired and itchy eyes.

A local eye doctor says the blue-light-blocking glasses actually improve your eyesight by about seven percent when looking at your phone, a computer screen, or a television.

Making it more effective than simply dimming down the brightness.

You see details more clearly so you will be able to resolve letters easier so that makes you work less, so you feel less fatigued. What happens when you dim down the screen intensity, you dont see the contrast as well so you cant see details as well and the result of that is you get more fatigued from your computer, said Dr. Richard Mauer, who works at the Eye Center of Florida.

Mauer says blue light blocking treatment on eyeglass lenses can be as cheap as $30 depending on your vision plan.

Amazon sells nonprescription glasses for as little as $13.

An option that appealed to Megan Tripp, a mother of two who has concerns about long terms impacts the increased screen time could have on her children.

He has more headaches, hes grumpier, its harder for him to break away from whats in front of that screen or what is reality, Tripp said.

Megan says its also important to give your kids a break from the computer. Thats why after a couple of hours of work she takes them outside for some natural light and fresh air.

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Vision to Learn helps Beaver County students see for free – The Times

August 13th, 2020 7:52 pm

Chrissy Suttles| csuttles@timesonline.com

AMBRIDGE Mindy Reynolds niece, Andy, will be learning remotely this fall as COVID-19 concerns remain high in her family and throughout the region.

One of her first thoughts while registering Andy for online learning was possible vision strain. Her prescription lenses are several years old, and more screen time could further hurt her eyesight.

An estimated 30,000 children in southwestern Pennsylvania lack access to proper vision care, according to the nonprofit Vision to Learn. The organization provides free eye exams and glasses to kids in high-need communities via a mobile clinic.

On Wednesday, the group stopped at Good Samaritan Catholic Church in Ambridge to give 18 youngsters in Beaver County new glasses ahead of the school year.

Shes so excited, Reynolds said. Things have been rough for a lot of families lately, so this is one easy win.

Vision to Learn has served about 280,000 kids nationwide since 2012, and about 5,000 in the Pittsburgh region since launching locally two years ago.

Wednesdays visit was their first stop in Beaver County, although the group will be partnering with Aliquippa schools this year to serve even more students; Vision to Learn partners with more than 20 school districts in the region.

Mobile clinics are equipped with self-contained optometric exam lanes with licensed optometrists. If students glasses are lost or broken, Vision to Learn replaces them for free within a year.

Its amazing to see a kid who is able to see clearly for the first time, said Vision to Learn program director Mark Scaramuzzi. For a lot of kids, they don't know they cant see. They don't know their vision is poor because its the way they've always seen. Its incredibly rewarding.

In western Pennsylvania, transportation is a significant barrier to families receiving proper care, he said, alongside low income and lack of insurance. Local staff members have traveled from New Castle to Washington, and everywhere in between, to help as many local families as possible.

We see kids on a daily basis, and sometimes its been multiple years since their glasses were broken and not replaced, Scaramuzzi said. You see kids who, in a lot of cases, have never had glasses and have very poor eyesight.

Since the start of COVID-19, staff has modified protocols to ensure social distancing. Only one child at a time can be seen at the clinic, and stations are thoroughly cleaned between each patient.

But summertime allows the group to see a greater variety of children before returning to schools in the fall.

If you cant see, you cant learn, Scaramuzzi said. And, particularly, in light of all the issues going on with COVID, were seeing more demand than ever.

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My Health, My Choice: Glaucoma, the silent thief of sight – VVdailypress.com

August 13th, 2020 7:52 pm

Open-angle glaucoma is a disease of the eye that can slowly and painlessly cause permanent loss of vision. It rarely causes any symptoms until its in an advanced stage, which is why its known as the silent thief of sight.

Glaucoma is a leading cause of irreversible blindness in the world. If you have risk factors, being proactive and getting your eyes checked is incredibly important. Your ophthalmologist can spot the signs of early glaucoma and help stop vision loss.

So what exactly is glaucoma?

Glaucoma is a progressive disease of the optic nerve when the pressure in the eye is higher than the nerve can tolerate. Patients begin to lose their peripheral vision and over time this progresses inward. Patients with glaucoma rarely have complaints until the disease has advanced to the center of their vision; however, it is often too late to help at that point because the damage is not reversible. With early diagnosis by an eye doctor, there are many treatments available to stop glaucoma from advancing.

What can cause open-angle glaucoma?

The nerve damage in glaucoma in most cases is due to an increased pressure in the eye. Pressure levels vary for each patient and even throughout the day. Pressure is maintained by aqueous humor or fluid in the eye that is constantly produced by a tiny gland in the eye the ciliary body. This fluid flows between the iris and the lens, then out of the eye through a very small drain called the trabecular meshwork. Pressure in the eye is elevated for two main reasons: The trabecular meshwork drain is clogged and enough fluid doesnt leave the eye, or the ciliary body produces too much fluid. This elevated pressure typically does not cause any symptoms and will silently damage the nerve.

Whos at risk of developing Glaucoma?

Anyone can get glaucoma; however, some individuals are at higher risk for developing glaucoma. Those at highest risk are African American patients over the age of 50, Hispanic patients over the age of 65, patients with a family history of glaucoma and patients with diabetes. Medicare recommends to have yearly screenings for patients who fall under any of these high-risk groups in order to catch the disease at its earliest state.

How to check for glaucoma

Thanks to advances in medicine, we have the ability to diagnose glaucoma earlier and more accurately. A typical evaluation includes a comprehensive eye exam where an eye doctor analyzes the nerve for damage and measures the pressure in the eye, which should range between 8 and 21 mmHg. Additionally, there are two other tests performed to accurately diagnose if you have the disease and what stage. First, an OCT nerve scan is used to detect subtle thinning/damage of the nerve. Secondly, a visual field is performed to test for areas of missing vision.

How is glaucoma treated?

When diagnosed and treatment has begun, it is a lifelong disease that will require continuous management. We can control or slow the progression, but unfortunately cannot reverse or cure glaucoma. There are many eye drops available and, depending on the severity, more than one medication may be needed. If glaucoma cant be controlled with medications, other procedures such as laser or surgery may be considered.

For more information about glaucoma or any eye disease, call Dr. Jhaj at his office directly at 442-255-4012.

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Gyroscope Therapeutics Announces Initiation of Phase II Programme Evaluating its Investigational Gene Therapy, GT005, for Dry Age-Related Macular…

August 13th, 2020 7:52 pm

LONDON--(BUSINESS WIRE)--Gyroscope Therapeutics Limited, a clinical-stage retinal gene therapy company, today announced the initiation of its Phase II programme evaluating its investigational gene therapy, GT005, for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). Dry AMD is a leading cause of permanent vision loss in people over the age of 50. GT005 is a one-time AAV-based gene therapy that is delivered under the retina. The goal of the Phase II clinical trial programme is to determine if GT005 has the potential to slow the progression of GA.

Gyroscope plans to conduct two Phase II trials evaluating GT005 in people with GA. The first, called EXPLORE, is enrolling people who have a mutation in their Complement Factor I (CFI) gene [NCT04437368]. The first patient to receive GT005 in EXPLORE was enrolled and dosed by Dr. Arshad M. Khanani at Sierra Eye Associates in Reno, Nev., USA.

Geographic atrophy is a devastating diagnosis, as there are no approved treatments for this gradual and irreversible loss of vision, said Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor at the University of Nevada, Reno School of Medicine, and an investigator in the EXPLORE trial. We are excited to participate in this trial evaluating GT005 for the potential to slow progression of geographic atrophy. We believe one-time gene therapies could be a major advancement in the field of retinal disease.

GT005 is designed to restore balance to an overactive complement system, a part of the immune system, by increasing production of the CFI protein. An overactive complement system has been implicated in the development of AMD. The CFI protein regulates the activity of the complement system. It is believed that increasing CFI production will dampen the systems overactivity and reduce inflammation, with the goal of preserving a persons eyesight.

Research has found that approximately 3% of people with dry AMD have certain CFI mutations that correlate with low CFI levels in the blood and a higher risk of developing AMD.1 Gyroscope estimates that more than 100,000 people with GA in the United States and EU5 European countries may have these mutations.1,2,3,4 The EXPLORE trial will evaluate GT005 in this group of people with mutations in their CFI gene.

Research has also shown that a small supplementation of CFI can normalise complement activity in the blood,5 suggesting GT005 may also be applicable for a broader group of people with GA. It is estimated that approximately one million people in the United States alone have GA.4 Gyroscope therefore plans to initiate a second Phase II trial in 2020 that will evaluate GT005 in a broader GA population.

We are excited about the potential of GT005 for people with dry AMD. Research suggests GT005 may be best suited for people with certain mutations in their CFI gene. However, evidence also suggests it may have potential for a broader population of people with geographic atrophy, said Nadia Waheed, M.D., MPH, Chief Medical Officer of Gyroscope. We have designed our clinical programme to evaluate these groups in two distinct Phase II trials, with the goal of determining which patients GT005 may be most appropriate for and to further our understanding of the role of the complement system in AMD.

About the EXPLORE Trial

EXPLORE is a Phase II, multicentre, randomised trial evaluating the safety and efficacy of GT005 administered as a single subretinal injection.

EXPLORE is enrolling people who are aged 55 or older and have a clinical diagnosis of GA secondary to dry AMD and who have a mutation of the CFI gene. People being screened for the trial will be genotyped for the mutations. Trial participants will be randomised to one of three treatment arms: GT005 dose 1, GT005 dose 2 or a control arm. Participants in the control arm will receive current standard of care. The primary endpoint of EXPLORE is progression of GA over 48 weeks. The study will also evaluate GT005 for various safety and tolerability measures. Gyroscope plans to enroll approximately 75 patients at approximately 40 centres based in the United States, United Kingdom, Europe and Australia.

Gyroscope will announce details about the second Phase II trial of GT005 at a later date.

About Age-Related Macular Degeneration (AMD) and Geographic Atrophy (GA)

AMD is a leading cause of blindness affecting an estimated 196 million people globally.6 AMD typically affects people aged 50 and older, and causes a gradual and permanent loss of central vision that worsens over time.7 There are no approved treatments for the dry form of AMD, which is the most common, impacting approximately 90% of people with the disease.8 As dry AMD advances it leads to GA, an irreversible degeneration of retinal cells. This vision loss can be devastating, severely impacting a persons daily life as they lose the ability to drive, read and even see the faces of loved ones.

About Gyroscope Therapeutics: Vision for Life

Gyroscope Therapeutics is a clinical-stage retinal gene therapy company developing and delivering gene therapy beyond rare disease to treat a leading cause of blindness, dry AMD. Our lead investigational gene therapy, GT005, is a one-time therapy delivered under the retina. GT005 is designed to restore balance to an overactive complement system by increasing production of the Complement Factor I protein. GT005 is currently being evaluated in a Phase I/II clinical trial called FOCUS and a Phase II clinical trial called EXPLORE.

Syncona Ltd, our lead investor, helped us create the only retinal gene therapy company to combine discovery, research, drug development, a manufacturing platform and surgical delivery capabilities. Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness. For more information visit: http://www.gyroscopetx.com and follow us on Twitter (@GyroscopeTx) and on LinkedIn.

References

1 Kavanagh D, Yu Y, Schramm EC, et al. Rare genetic variants in the CFI gene are associated with advanced age-related macular degeneration and commonly result in reduced serum factor I levels. Hum Mol Genet. 2015;24(13):3861-3870.2 Data on File.3 Friedman DS, O'Colmain BJ, Muoz B, et al. Prevalence of age-related macular degeneration in the United States [published correction appears in Arch Ophthalmol. 2011 Sep;129(9):1188]. Arch Ophthalmol. 2004;122(4):564-572.4 Rudnicka AR, Kapetanakis VV et al. Incidence of late-stage age-related macular degeneration in American whites: systematic review and meta-analysis. Am J Ophthalmol 2015;160:85-93.5 Lachmann PJ, Lay E, Seilly DJ, Buchberger A, Schwaeble W, Khadake J. Further studies of the down-regulation by Factor I of the C3b feedback cycle using endotoxin as a soluble activator and red cells as a source of CR1 on sera of different complotype. Clin Exp Immunol. 2016;183(1):150-156.6 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106116.7 National Eye Institute. Age-Related Macular Degeneration. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration. Accessed July 16, 2020.8 Centers for Disease Control and Prevention. Age-Related Macular Degeneration. https://www.cdc.gov/visionhealth/basics/ced/. Page last reviewed June 3, 2020. Accessed August 4, 2020.

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Eye Health Ingredients Market 2018 2025 What Recent Study Say About Top Companies | Trends Market Research – eRealty Express

August 13th, 2020 7:52 pm

Global Eye Health Ingredients Market: Overview

Toxic impurities in contact with eyes cause adverse effects on eyesight leading to unhealthy vision. Antioxidants such as Lutein and Zeaxanthin of the carotenoid family are some of the eye health ingredients. Use of antioxidants as eye health ingredients is expected to grow steadily over the forecast period. Increase in number of eye health supplements is also projected to enhance the growth of eye health ingredients market during the forecast period. In addition, protection from UV radiation, elimination of free radicals, need for powerful vision, and high demand for vision sustenance are some of the prominent factors driving the eye health ingredients market.

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Increasing eye health problems including cataract, glaucoma, diabetic retinopathy, and Age-Related Macular Degeneration (AMD) are expected to fuel the growth of the global eye health ingredient market. Also, large spending on nutritional products has influenced the pharmaceutical industry growth. Increasing exposure to digital displays, rising prevalence of allergies, and changing lifestyle have resulted in more eye diseases, which, in turn, is projected to bolster the growth of global eye health ingredients market.Eye Health Ingredients Market size was worth over USD xx million in 2018 and is set to exceed 1.8 kilo tons by 2025.

Some of the key players involved in the global eye health ingredients market are Amway, MacuShield, Bausch & Lomb Incorporated, Novartis AG, Solgar Inc., Swanson Health Products, Allied Biotech Corporation, BASF SE, DSM, Kemin Industries Inc., Davos Life Science Pte ltd., Wilmar International Limited, and Vitae Naturals.

Global Eye Health IngredientsMarket: Segmentation

By Source Type

Natural SourcesSynthetic SourcesBy Ingredient Type

LuteinZeaxanthinVitamin ABeta-caroteneBilberry extractsForm Type

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PowderLiquidOthers (Capsule, Soft Gels, Tablets)By Application:

HumanAnimalBy Disease Indication

CataractAge related Macular Degeneration (AMD)Dry Eye SyndromeOthers

Natural source segment accounted for the largest market share in the global eye health ingredients market in 2017. The growing consumer awareness regarding benefits of natural health sources is expected to fuel the demand for natural eye health ingredients. Lutein and zeaxanthin, the most commonly used ingredients, are usually combined with other health beneficial components such as vitamins A, C, B, and minerals such as zinc and selenium.

North America is expected to be the most lucrative market for eye health ingredients followed by Europe and Asia Pacific. Increasing incidence of low vision and blindness among the people in North America has led to an increased demand for eye health ingredients. Rising geriatric population coupled with increasing consumer spending on healthcare, preference toward healthy lifestyle, and factors such as occupational hazards and smoking, which cause eye-related diseases, are expected to propel the growth of eye health ingredients market globally during the forecast period. The Food and Drug Administration (FDA) does not recommend a safe upper limit for eye health ingredients such as lutein, zeaxanthin, beta carotene, and bilberry extract, making consumers apprehensive about the dosage levels in both functional foods and dietary supplements. Technological advancements and innovations put forth by the manufacturers to expand their portfolio are expected to augment the market growth.

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In February 2016, Waitaki Biosciences, one of the key manufacturers of natural nutritional products, launched CassiPure, anthocyanin rich blackcurrant extracts for eye health and immune support. Similarly, in July 2016, Nestle Taiwan launched upgraded Nestle Good Health Nutrition product for eye health among the middle-aged population, particularly for those who spend several hours a day using smart phones.

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Anti-Aging and Prolonging Life By John Robert Cardillo – Health News Tribune

August 13th, 2020 7:51 pm

Youth, we all want to enjoy an extended life, and we work to find ways to perpetuate our lifespan. In the 16th century, a Spanish explorer, Ponce de Leon, explored the southern U.S. looking for the fountain of youth and ended his quest in St Augustine, Florida. His quest was to drink and bathe in the fountain, as it was believed that the waters would reverse the aging cycle and allow a man to live forever.

To many, it sounded like science fiction, as life was believed to finite experience, but not anymore. A Harvard University geneticist, Dr. David Sinclair PhD, has cracked the code of aging Working at Harvard Medical, Dr Sinclair has discovered, through multiple studies, that the aging cycle can be manipulated and reversed when certain factors are present in the equation. One of the many discoveries that he brought to academia surrounds fasting and reversing the effects of aging in humans. His experiments with yeast were the first to determine that a cause of aging for yeast as well as the role of Sir2 in epigenetic changes driven by genome instability, according to his biography at the Blavatnik Institute of Genetics at the Harvard Medical School.

In his book Lifespan, Dr. Sinclair explains that his clinics research focused primarily on sirtuins, which is a protein modifying enzyme which is responsive to changing levels of NAD during fasted calorie restriction.

Dr. Sinclair is also studying chromatin, how energy is metabolized in the mitochondria, memory and learning neurodegeneration, cancer causes.

Dr. Sinclairs Harvard Medical was credited with identifying NAD bio-synthesis in regulating lifespan, which was the first to show the involvement of sirtuins in calorie restrictions of mammals. His book states that a small molecule, resveratrol, was identified to activate on SIRT1. This improved the cells metabolic function by using combinations of enzymological, genetic, pharmacological and biophysical approaches.

They showed recently that synthetic and natural activators require SIRT-1 to mediate the in vivo effects in muscle and identified a structured activation domain.

The study concluded that the miscommunication between the mitochondrial and nuclear genomes is a cause of the age related physiological decline and the relocation of chromatin factors in response to DNA breaks may be a cause of aging

Dr. Sinclair is a renowned scientist and best-selling author and advises the world that we cant live forever, but we can live longer if we take the right steps to extend our health.

The most important discovery that Sinclair has made is the presence of Resveratrol in plants that acts as protective shield injuries and pathogens. Resveratrol is an oxidant and is found in foods like grapes, blueberries, and cocoa, and when consumed, it can counteract the aging cycle. In his seminal work, Lifespan: Why We Age- and Why We Dont Have To, Dr. Sinclair addresses a concept called health span. In a nutshell, it means that if you arent sick, dont have chronic conditions or diseases; you wont experience mortality early. In essence, if you can prolong your health span, you increase your life expectancy.

Dr. Sinclair bases his conclusion on many factors but says fasting is good for the body and is a crucial driver of human longevity. He has said on many occasions that the science behind this conclusion is now solid. For over 20 years, scientists have debunked the myth that humans need three meals a day and snacks to achieve optimal health.

Dr. Sinclair doesnt advocate starvation; he says that you dont need to be hypoglycemic and have low blood sugar because that makes us weak and dizzy. But reduced caloric intake is good for the body. Fasting activates the bodys survival instinct, and that is a good thing when it comes to anti-aging. According to Dr. Sinclair, it starts with the survival circuit, and it has been part of the human body for time eternal. The proven theory goes like this (and its in all life on the planet), when a threat occurs in the living organism, the survival circuit will be activated, and it helps us live longer and healthier when faced with danger.

The way it works is simple. When you work out and are short of breath during your workout, it is good. Suppose you wake up hungry and skip breakfast and eat a late lunch that is good also. A chemical in your body, nicotinamide adenine dinucleotide (NAD), will flood your body and the sirtuins (a protective enzyme), the critical ingredient in the survival circuit will activate.

Sinclair says that exercise is a good thing as it activates the survival cells, and movement is the reason. Exercise puts the body under pressure, and like fasting, it causes our involuntary physiology to work to protect the host.

Dr. Sinclair is an advocate of supplements to help generate the chemicals the body needs to extend life. He says that Resveratrol the NAD activator, and metformin is essential to consume for the extension of life.

Metformin is a big help for middle-aged people and older people to stave off the effects of aging. Also, it works to counteract the effects of Type-2 diabetes. It will lower rates of heart disease, cancer, frailty, and the onset of Alzheimers for people who take metformin.

Certainly, exercise will stimulate the sirtuins in our body Dr. Sinclair has said many times, but fasting is an essential component of the anti-aging cycle. Dr. Sinclair has determined in the lab that the aging cycle can be slowed and reversed. His experiments have not just stopped the aging clock; the experiments have turned back the hands of time, which is monumental. A classic example of this is an 80-year old who doesnt look their age. They are mistaken for a much younger person because they have been using fasting and exercise to force their bodies to prevent the aging cycle from creating disease and health problems that reduce our lifespans. Our molecular clocks drive our aging cycle, and when we stop that time from moving forward or slow it to a crawl, we live a lot longer than someone who hasnt engaged in exercise and fasting to create a perfect storm of anti-aging.

Dr. Sinclair said that studies in mice accentuate the point. The studies were able to extend the life of mice by 50 percent, and it only in the last ten years that the discoveries have been made.

Initially, Dr. Sinclair was branded a maverick, and a crackpot advocating that life expectancy can be extended through fasting and exercise. Dr. Sinclair says in the book that reprogramming our molecular cells will stimulate the long-lasting effects of anti-aging.

In the book, Dr. Sinclair said that scientists have been unable to decide how many times the molecular clock can be reset. Still, he sees the potential to eradicate some diseases in our lifetime. He posed if were able to turn back the molecular clock through fasting and exercise, we may be able to reduce the risk of cancer and heart disease. As humans age slower, it is forestalling the onset of illness and chronic inflammation. Sinclair does make clear, though, that humans will not live into perpetuity even if there is a reset of the clock.

In a study conducted by Dr. Sinclair in his lab at Harvard, he was able to reverse vascular aging in mice. The backstop of the book he wrote on anti-aging that tells us that fasting is the driver to helping prolong life. The molecules, NAD, and sirtuin manufactured during times of stress like exercise and fasting have caused stamina to be boosted, and endurance in the mice test subjects. The blood vessels are forced to grow, and that reverses the aging cycle for the vascular system. The experiments are the staging ground for the human condition, and the experiments will lead to addressing the root causes of diseases in humans that come from aging. Dr. Sinclair was quick to tell us that the biological differences between humans and mice are vast, and not all results in the lab can be replicated for humans.

When we age, our smallest blood cells will die, which reduces blood flow in our bodies. With reduced blood flow come vascular disease and a host of other problems attributed to old age. Reduced oxygen levels through the loss of blood flow allow toxins to build up in the body, and deterioration of the body occurs. This problem affects the endothelial cells; they line the blood vessels in our bodies and are critical to the bodys supply chain. The endothelial cells cause the growth of the blood cells that help transport oxygen and nutrients to our organs and tissues.

Aging and deterioration of muscles and blood vessels reduce life expectancy, and the endothelial cells lose a vital protein sirtuin and it is affected by the loss of NAD. NAD is our bodys protein regulator, and it is the repair kit for our DNA.

When mice were subjected to an exercise-based program, the signs of aging were slowed and eventually reversed. When the exercise wasnt present in the test subjects, proteins were reduced, and the process for regeneration of blood vessels wasnt activated.

When NAD and sirtuins were created with exercise and fasting, the body demonstrated an innate ability to fight off the aging process.

The mitochondrial networks that exist inside our cells are where the reactions take place. Through dietary restrictions and exercise, the mitochondria can increase your lifespan and improve your current health. The mitochondria are the energy factory for our body and can shapeshift according to the bodys energy demands. As we age, the dynamic of the function of the reaction slows, and it impacts our metabolism. Through exercise and fasting, the chemical reactions created work in unison to keep threats at bay and supply the organs through the bloodstream with the chemicals the body needs to fight off threats.

Through a series of studies, fasting or dietary restrictions manipulated through an energy identifying protein kinase helped the mitochondrial networks maintain youthfulness.

The process was termed healthy aging, and understanding the process is critical to advancing the application to humans to slow aging. Dr. Sinclair and other scientists have understood that fasting slows the aging process, but they dont have a handle as to why it occurs in the body chemistry.

To begin to understand the process and how it reflects in obesity will be the next step to a longer life. Obesity can be linked to defective mitochondrial flexibility and the increase in age-related diseases and chronic conditions from obesity.

The scientific community only just understands the biological manifestations of the human body. Still, Sinclair and other researchers have learned that exercise and fasting are essential components to slowing the aging process internally.

John Cardillo is a Canadian body building champion, renownerd fitness entrepreneur and the pioneer of the HIT3 exercise program. John Cardillo is Canadas premier health and fitness expert!

Erik Horn has been a senior editor at Health News Tribune for three years. Fluent in French and proficient in Spanish and Arabic, he focuses on diseases and conditions Hes a born-and-raised Torontonian and spends most of his weekends in search of strong coffee and stronger Wi-Fi.

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Environmental legislation to be biggest limiting factor for NI dairying in 2030 – Agriland.co.uk

August 13th, 2020 7:51 pm

One of Northern Irelands leading dairy researchers has warned he expects environmental legislation to be one of the biggest limiting factors to the industry locally by 2030.

Speaking as part of the Agri Food and Biosciences Institute (AFBI) webinar The Future of Dairy Production to 2030, Dr. Conrad Ferris said environmental factors, such as ammonia emissions, had already begun to impact the industrys growth.

Dr. Ferris said: As we look to the future for our dairy sector there are certainly lots of challenges, but as in most areas of life, challenges often bring opportunities.

Structural changes over the last 20 years have seen the total number of herds fall by around 25 a year. Meanwhile, the average herd size has increased by around two cows a year.

However, Dr. Ferris said he believed total cow numbers will remain relatively stable over the next decade.

Production in terms of litres has continued to grow, currently increasing by around 55L/cow/year. And I dont see any reason to believe that is going to slow down, he said.

Certainly, with genetic indexes, we can continue to improve production and improve fertility and health.

However, I do believe the biggest challenge to the overall structure of the dairy sector going forward is environmental legislation and I believe that is what will probably have the biggest impact on the structure of the local dairy sector.

Legislation is already impacting herd expansion on some farms, he added, referring to delays over agricultural planning associated with tightened restrictions over ammonia emissions.

Dr. Ferris said it was likely environmental legislation would continue to tighten for the industry. However, explained that anything the sector can do to become more efficient would have benefits for both its profitability and its environmental impact.

In terms of genetics and nutrition, I think there is a real win-win situation in that we know that anything we do to improve the overall efficiency of the whole milk production system right from calf-rearing, getting heifers calving down at 24 months, increasing longevity, the whole picture reduces greenhouse gases and ultimately improves profitability, Dr. Ferris said.

Over the last two decades, we have seen a real escalation in environmental challenges for dairy farmers. Back around 2000, water quality issues became a big issue in Northern Ireland driven by the Nitrates Directive and water quality in regards to phosphorous.10 years later, it was the climate change issue.

The key thing here is that it is cumulative just because now we are focused on ammonia doesnt mean that issues like water quality and climate change have gone away.

In reality, we are now trying to deal with all three of these, while 20 years ago we were only focused on water quality.

Dr. Ferris explained thatmany gains made in terms of water quality had been lost in recent years. Soluble reactive phosphorous levels in rivers had fallen from 2005 until 2012 but have now risen back to the 2007 figure almost wiping out 15 years worth of progress.

There are all sorts of reasons for that. But in terms of [agriculture], I do believe that reducing phosphorous levels in our concentrates, which is something our feed industry has already adopted. [This is] something that, going forward, we will have to push further and we will likely have to move even lower in terms of new levels.

As a result, research is expected to begin soon at AFBI examining the impact of lower protein diets for dairy cows. It will test what effect reducingprotein in cows diets has on farm ammonia emissions.

Meanwhile, promising research carried out by the institute also shows the potential to replace imported feedstocks with protein sources grown in Northern Ireland.

As part of the study, researchers were able to replace imported soya with locally-grown field beans completely without major impacts on milk composition. Reducing the food miles of animal feed could help further reduce the industrys emissions.

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Healthy ageing.. The eight R’s – Daijiworld.com

August 13th, 2020 7:51 pm

Aug 13, 2020

Each one of us aspires to live a long and healthy life. The environment we live in influences our behaviour, and exposure to risk. Thus a need arises for quality health and support. Every one of us can experience healthy ageing. Healthy Aging is developing the environments and opportunities that enable people to be and do what they value throughout their lives.

WHO defines Healthy ageing as the process of developing and maintaining the functional ability that enables wellbeing in older age. Functional ability is made up of the inner capacity of the individual, relevant environmental conditions, and the interaction between them. The inner capacity is influenced by factors like mental and physical behaviours, genes, age-related changes, and genetics. The Environment includes housing, community, transportation, attitudes, values, social facilities, assistive technologies, and the support system.

Elderly is an incredibly valuable resource for society and to continue being an active person in the society, elderly too without age discrimination should participate/engage and or get opportunities in activities boosting their physical, social and mental wellbeing. The decade from 2020 to 2030 is described by the United Nations as a 'Decade of healthy aging'. Older people are the main focus of this plan and also an aim to bring together civil society, governments, interdisciplinary professionals, international agencies, media, and private sectors to improve the lives of older people, their families, and communities. Through this article, I would like to mention the 8Rs as tips for healthy aging.

1. Regular exercise and physical activity: Exercising regularly and involving oneself in physical activities like walking with the pet, gardening, using stairs, and brisk walking increases stamina and improves health. Exercises help to prevent falls, reduces the risk of bone stiffening, and free movement of muscles. It can be an effective treatment for diseases like arthritis, heart ailments, diabetes, etc.

2. Routine checkups: Ageing itself is a challenge to be healthy, leading to increased doctors visits and need to care. With proper health check-up packages, physicians can detect the early signs of disease and help maintain the baseline and promote healthier aging. Other than the routine tests we undergo, depending on the gender there are additional tests that one needs to check. Its also necessary that like the way we check our physical and functional health, due importance should also be given to our cognitive and emotional health.

3. Relax: Engaging in the activities of ones interests can be relaxing. Sticking to the sleep schedule helps the elderly with insomnia. Some simple tips to be followed include avoid caffeine in the evening, keep the bedroom dark, turn off the cell phone, avoid naps more than 20 minutes during daytime, etc. Deep breathing and meditation can help ease stress, pain, and increase flexibility. Keeping a gratitude journal strengthens emotional resilience.

4. Rich nutritious diet: Many health issues are connected to overweight or obesity but being thinner is not healthier either. Dietary patterns influence the BMI, thus diet must include fibre-rich foods, low-fat dairy products, fruits, vegetables, and lean meat products. Supplements strictly prescribed by doctors like calcium, vitamin B6, B12, and D can be included. Intake of enough liquids is necessary not to get dehydrated.

5. Recreational activities: Well-planned recreations such as listening to music of interest, involving in art and craft, visiting old friends, playing board games, volunteering work, and engaging in old hobbies helps elderly utilize their leisure time, and improve their physical and psychological wellbeing.

6. Restrain from alcohol, smoking, and other addictions: Recent studies have shown that midlife and late-life smokers had a greater risk of developing dementia. Tobacco harmed daily functioning. (Michel et al, 2016). The positive effect of light to moderate alcohol consumption on longevity was completely rejected by a 6 year follow up Pianoro study. Systematic review and meta-analysis of longitudinal studies on alcohol consumption and healthy ageing revealed equivocal results. (Daskalopoulou, et al, 2018). However, it needs more research in this area.

7. Research on healthy ageing: Practitioners, professionals, and researchers must consider research addressing topics on the current needs of elderly, future challenges, and determinants of healthy ageing and interventions to improve healthy ageing trajectories. Studies can also emphasize on research priorities and gaps to improve health equity. Thus contributing to and learn from such a knowledge base.

8. Reverse approach: We will not hold their hands; they will hold our hands. One should not underestimate the elderly power only due to their age. The knowledge, skills, and experience they have should not be devalued. Important here is they should not be placed in the receiving end. They are an asset and guide for preserving the cultural and folk traditions, old values, and rituals.

I would also like to inform the readers that the Manipal Academy of Higher Education (MAHE) in May 2020 has launched the Centre for Studies on Healthy Ageing (CSHA) aiming to promote health and participation in old age. The centre also encourages young groups to age healthy and be independent.

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Research to Prevent Blindness and Association of University Professors of Ophthalmology Announce 2021 Recipient of RPB David F. Weeks Award for…

August 13th, 2020 7:50 pm

Newswise SAN FRANCISCO, CA and NEW YORK, NY, August 13David Williams, PhD, has been selected as the 2021 RPB David F. Weeks Award for Outstanding Vision Research (Weeks Award). The Weeks Award, funded through the generosity of Research to Prevent Blindness (RPB), an anonymous donor, and the Association of University Professors of Ophthalmology (AUPO), annually recognizes and celebrates an excellent vision researcher. The award carries the name of David F. Weeks, former President and Chairman of RPB, in honor of his contributions to the field of vision research. Dr. Williams will receive his award and deliver a presentation during the AUPO 2021 Annual Meeting in February.

Dr. Williams holds the position of William G. Allyn Professor of Medical Optics at the University of Rochester. David Williams contributions to understanding the optical factors in vision have been profound. The impact of his research establishes him as one of the outstanding visual scientists in his generation, and his creative ideas for future vision research have the potential to ultimately unlock the discoveries needed to cure blindness, said David A. DiLoreto, Jr., MD, PhD, Chairman for the Department of Ophthalmology at the University of Rochester.

AUPO President, David Quillen, MD shared, We are thrilled to recognize Dr. Williams with the Weeks Award. Dr. Williams is one the world's leading experts on human vision. He and his team have transformed ophthalmology and visual science through the development and implementation of the first adaptive optics system for the eye. This work has resulted in unprecedented developments in patient care including wavefront-guided refractive surgery and exquisite retinal imaging. It is a remarkable story that will continue to advance our understanding of the eye and vision.

Dr. Williams work is the kind of ground-breaking research that fulfills Mr. Weeks vision for the advancement of vision science via his work at RPB and his advocacy activities that were key to the creation of the National Eye Institute, said Brian F. Hofland, PhD, President of Research to Prevent Blindness. On behalf of RPB, I extend my sincerecongratulationsto Dr. Williams on all of his past accomplishments, and I look forward to his future innovations.

For more information on the RPB David F. Weeks Award for Outstanding Vision Research, visit the AUPO website.

About Research to Prevent Blindness

Research to Prevent Blindness (RPB) is the leading nonprofit organization supporting eye research directed at the prevention, treatment or eradication of all diseases that damage and destroy sight. As part of this purview, RPB also supports efforts to grow and sustain a robust and diverse vision research community. Since it was founded in 1960 by Dr. Jules Stein, RPB has awarded more than $373 million in research grants to the most talented vision scientists at the nations leading medical schools. As a result, RPB has been associated with nearly every major breakthrough in the understanding and treatment of vision loss in the past 60 years. Learn more atwww.rpbusa.org.

About Association of University Professors of Ophthalmology

The Association of University Professors of Ophthalmology (AUPO) was founded in 1966 as a nonprofit organization dedicated to research and education. AUPO is the voice of academic ophthalmology through the promotion of medical education, research, and patient care in ophthalmology, and accomplished by providing a forum for discussion of mutual issues facing departments/divisions of ophthalmology in the United States and Canada. For more information, visit aupo.org.

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X Ambassadors Teams up with Foundation Fighting Blindness and Two Blind Brothers to Launch Music to our Eyes Exclusive Livestream Music Series -…

August 13th, 2020 7:50 pm

X Ambassadors' keyboardist, Casey Harris, was born with the rare genetic disease, Senior-Loken syndrome, which affects his kidneys and retinas. The acoustic performance by brothers Sam and Casey Harris will feature their top hits including, Renegade, Unsteady, Hold You Down, and Belong. In between sets, Jason Menzo, chief operating officer at the Foundation Fighting Blindness, will interview Sam and Casey about their experiences with vision loss and discuss their commitment to creating music that celebrates diversity and belonging. Event registration is free, but attendees will have the opportunity to contribute, as all net proceeds will go towards the Foundation's mission.

"We are so excited and honored to be collaborating with Two Blind Brothers for this livestream conversation and acoustic performance with Sam and Casey Harris of X Ambassadors," says Jason Menzo, COO at the Foundation. "Together, we have this natural connection and unwavering commitment to providing hope and empowerment for the blind and visually impaired community."

For more information and to register for a reminder about the event, visit: https://bit.ly/3ihTkda

About the Foundation Fighting BlindnessEstablished in 1971, the Foundation Fighting Blindness is the world's leading private funding source for retinal degenerative disease research. The Foundation has raised more than $800 million toward its mission of accelerating research for preventing, treating, and curing blindness caused by the entire spectrum of retinal degenerative diseases including: retinitis pigmentosa, age-related macular degeneration, Usher syndrome, and Stargardt disease. Visit FightingBlindness.org for more information.

Media Contacts:Chris Adams Vice President, Marketing & Communications [emailprotected] (410) 423-0585

SOURCE Foundation Fighting Blindness

http://www.FightBlindness.org

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Lifting the burden of cornea blindness through donation – The Star, Kenya

August 13th, 2020 7:50 pm

Cornea is the clear tissue covering the front of the eye and is the main focusing part of the eye. If it becomes cloudy or scarred, say, due to an eye injury or infection, vision is reduced or lost because the scar tissue scatters the light passing through the cornea.

This is known as cornea opacity, which is considered a major public health problem. According to the World Health organisation, there are at least 2.2 billion people with vision impairment that could have been prevented or has yet to be addressed. Among these, those suffering from cornea opacities are about 4.2 million.

In Kenya, according to the annual report for the year 2018 by the Kenya Society for the Blind, there are about 350,000 people who are blind while another 750,000 are visually impaired. The Lions SightFirst Eye Hospital which is the biggest eye hospital in East Africa reports that cornea opacities contribute to 19% of blindness cases.

One of the ways to treat cornea opacity is with a cornea transplant, this can restore vision. Cornea transplant involves a surgical procedure which replaces a disc-shaped segment of an impaired cornea with a similarly shaped piece of healthy donor cornea. Though we do not have nationwide studies in Kenya it can be estimated that those in need of cornea transplant exceed 50,000 cases.

Journey of cornea transplant in Kenya

This year as the world marks the World Organ Donation Day, we chose to focus on cornea transplant in Kenya which is largely led by Lions SightFirst Eye Hospital. According to the experts in the hospital, there are competent surgeons in Kenya who are able to undertake the required surgery [known as Keratoplasty] to restore cornea opacity and surgical facilities are available for the procedure, but there has been shortage of donor corneas to meet the demand.

As a way of addressing this gap between supply and demand, there was established the first ever eye bank in East and Central Africa in the year 2007 which was named after its chief sponsor Lion Kanubhai Babla. The eye bank was established at the Lions SightFirst Eye Hospital. The eye bank which is still in operation obtains, medically evaluates and distributes donated corneas for use in transplantation, research and medical education.

Before the establishment of this eye bank, cornea transplants were done with donor corneas from abroad. The costs involved to either travel abroad for the surgery or to procure the corneas from abroad were too high for the majority of patients to afford thus remaining blind for the rest of their lives. The eye bank started, and still does, facilitating cornea transplant at minimal cost to the needy and deserving patients.

Currently the Lion Kanubhai Babla Eye Bank at Lions Eye Hospital is fundamental to the obtainment, screening and storage of donated eye tissue used for cornea transplant. The eye bank team provides a 24- hour information and retrieval service 365 days a year and it provides these services throughout the country but with priority to the needy especially students so that they can continue with their studies uninterrupted.

Where the eye bank gets cornea for transplant

Lion Kanubhai Babla Eye Bank relies on voluntary donation of corneas and only the corneas are obtained not the whole eyeball. Kenya performs about 200 cornea transplants annually with donations coming from non-native communities. This is mainly associated with cultural and religious beliefs surrounding death among the indigenous Kenyan communities. While pledging to become a donor, there is no monetary compensation given or any other form of incentives, either to the donor or to the family.

The time required to obtain cornea is 6-8 hours after death and it is stored immediately to avoid damage. The Lions Eye bank collaborates with eye bank ambassadors and other hospitals to assist in proper preservation of the donor bodies before the eye bank specialists can get to the harvesting point. Cornea can be removed at hospital or even at residence or wherever death occurs.

Only people above the age of 18 years are allowed to pledge their cornea because this is the consent age in Kenya. However, it is not suitable to transplant a cornea from an older donor to a young patient. A potential donor pledges at the Lions eye bank to give their cornea when they die. However, the family needs to give consent upon the death of the donor. It is therefore important that the donor notifies their family and has them understand the reason and implications of the decision. This prevents contention when the cornea needs to be obtained.

As the decision for eye donation is made by the family members when a death occurs, the commitment and involvement of the whole family is required. Eye donation will work best, when it becomes a tradition in every Kenyan family and a part of our culture, irrespective of religion and other aspects.

Elizabeth Mbugua and Stephen Rukwaro (Lions SightFirst Eye Hospital)

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Lifting the burden of cornea blindness through donation - The Star, Kenya

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Blindness is inventive and thoroughly engrossing a real light in our current darkness – iNews

August 13th, 2020 7:50 pm

While other theatres remain closed, the Donmar Warehouse in Covent Garden welcomes audiences four times a day to experience a socially distanced sound installation. After following a strict anti-Covid drill (distanced queuing and seating, sanitiser, face masks), people hear a recording over headphones of Juliet Stevenson narrating an adaptation of the Portuguese Nobel laureate Jos Saramagos 1995 novel Blindness.

Saramagos story is simple but, like Albert Camuss The Plague, even more resonant in the current climate. One day, a driver stops his car at some traffic lights because he cant see any more. It is soon apparent that this form of blindness is contagious and, within days, the whole city, then the country, is infected.

Caught up in the chaos of the inexplicable epidemic is an unnamed eye doctor, his strong-willed wife and some of their patients. As the Government uses the army to herd the sightless victims into a disused asylum for quarantine, it becomes clear the doctors wife is the only person who retains her sight.

Adapted by playwright Simon Stephens into a 70-minute narrative monologue, in which Stevenson also plays the doctors wife, Blindness shows how quickly society can disintegrate when an epidemic renders citizens vulnerable. The strong terrorise the weak; the government fails to control the sickness; but there is hope in collective solidarity despite acute adversity.

Loss of sight can mean a better perception rather than a disability, and this version of the novel is alive to current resonances. The announcements of the Government recall not only the injunctions of various military juntas, but also strike closer to home, talking glibly of a curve of resolution.

At other moments, the horror of a minister losing their sight during a press conference goes hand in hand with the feeling that often these events are designed to blind you with untruths. Likewise, the repeated notion of individual responsibility roots this universal fable in an Anglo-Saxon context.

A great part of the show is experienced in darkness, and Ben and Max Ringhams immersive binaural sound design allows Stevenson to whisper in your ear or rush across a room, shouting in the distance. She begins coolly and becomes increasingly desperate. The feeling of intimacy and reality iscompelling.

Walter Meierjohanns production also uses Lizzie Clachans design and Jessica Hung Han Yuns multi-coloured strip lighting to brilliant effect, all of which remind us of the importance of sight.

Blindness is inventive and thoroughly engrossing a real light in our current darkness.

To 22 August (020 3282 3808)

THEARTSDESK.COM

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Theatre review: Blindness – Metro Newspaper UK

August 13th, 2020 7:50 pm

REVIEWDonmar Warehouse, London

RIGHT now, it seems a small miracle that this penetrating, inventive piece of theatre exists at all. That it also speaks so eloquently to our Covid-afflicted present and our common humanity is an exhilarating testament to the power and necessity of art not least at times of crisis.

Its adapted from Jose Saramagos novel, in which a city is stricken by an epidemic of blindness. A bright, white sightlessness descends without warning and its virulently contagious. The rudderless government loses control (sound familiar?), society disintegrates and new hierarchies emerge, with the uninfected free to exploit and abuse. But there is hope, too, of rebuilding something better.

Written by Simon Stephens, Walter Meierjohanns production shrewdly embraces social distancing safeguards. Masks must be worn throughout, ramping up the sweaty, claustrophobic intensity. There are no live actors; the narrative unspools through binaural headphones, delivered by Juliet Stevenson as a doctors wife who escapes the virus and becomes a horrified witness and reluctant hero. The audience is scattered around the bare stage. Overhead hang angular rods of light, which rise and fall, changing colour, before blinking out, leaving us in absolute darkness.

Its an unnervingly intimate experience, with Stevensons feverish voice so close you can almost feel her hot breath on your skin. The sense of disorientation scarcely abates when the lights come up and you find yourself surrounded by masked figures, too far away to touch.

Its not always easy to endure. But at this particular historical moment, it is a unique and unforgettable achievement.

Blindness runs until August 22. donmarwarehouse.com

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Justifiable Bullishness Or Is It Willful Blindness? – Seeking Alpha

August 13th, 2020 7:50 pm

Currently, there is much bullish commentary suggesting stocks can only go higher from here. Is the bullishness in the markets justifiable, or is it willful blindness?

John Stoltzfus, CIO of Oppenheimer, is clearly in the bullish camp:

We remain very bullish on this market. Youre going to see money beginning to further move out of the bond market, and it makes all the sense in the world to be positioned in equities.

This seems a little optimistic given the amount of money that has already flooded into the 5-largest mega-cap stocks which have accounted for a bulk of this years market returns.

Nonetheless, it is an interesting question.

From the bulls viewpoint the focus has been the ability for these companies to grow earnings.

The bearish view is the problem with valuations.

As noted in COT Positioning Back To Extremes, the Nasdaq set repeated new highs in 2020, which is astonishing given the depth of the economic recession. To wit:

While the S&P 500 is primarily driven higher by the largest 5-market capitalization companies, it is the Nasdaq that has now reached a more extreme deviation from its longer-term moving average.

Moving averages, especially longer-term ones, are like gravity. The further prices become deviated from long-term averages, the greater the gravitational pull becomes. An average requires prices to trade above and below the average level. The risk of a reversion grows with the size of the deviation.

The Nasdaq currently trades more than 23% above its 200-dma. The last time such a deviation existed was in February of this year. The Nasdaq also trades 3-standard deviations above the 200-dma, which is another extreme indication.

The immediate conclusion is the drive higher in the markets is a function of massive amounts of liquidity being injected into the financial markets by the Federal Reserve. As shown below that was certainly the case during March and April.

However, since then the tapering of the liquidity injections by the Fed has been marked as the slowing uptake of the various programs reduced demand.

While there is indeed truth to the Feds impact on the market, it is not solely responsible for the dislocation of prices from the underlying fundamentals.

As shown, the decline in fundamentals didnt start during the pandemic. The decline in earnings started in early 2019 as economic growth slowed, and accelerated during the pandemic. However, during that same period stock prices rose, which is almost entirely attributable to valuation expansion.

E*Trade recently released survey data which showed that despite the market plunge in March, bullish sentiment has returned:

You get the idea. Just one quarter after panic selling lows, investors are once again back in the pool. Despite the economy just printing a nearly 40% decline in Q2, and earnings having dropped by nearly 40% from their peak, the dumb money is back to chasing stocks.

In particular, not only are retail investors chasing stocks, they are doing it with increased leverage by using options. As noted by CNBC recently:

Investors have reentered the market at a record rate following the coronavirus-induced sell-off in March, and as traders look to profit, options volume has soared to an all-time high.

The average daily value of options traded has exceeded shares for the first time, with July single stock options volumes currently tracking 114% of shares volumes.

In other words, the options market is now larger than the shares market.

We have seen record lows in the Put/Call ratio three times in 2020. All three lead to corrections.

Willful blindness, also known as willful ignorance or contrived ignorance, is a term used in law. Being willfully blind describes a situation in which a person seeks to avoid civil or criminal liability for a wrongful act by keeping themselves unaware of the facts that would render them liable or implicated.

Although the term was originally used in legal contexts, the phrase willful blindness has come to mean any situation in which people avoid facts to absolve themselves of their liability.

Willful blindness is most prevalent in the financial markets. Investors regularly dismiss the facts which run contrary to their current opinion. In behavioral investing terms this is also known as confirmation bias.'

As markets rise, investors take on exceedingly more risk with the full knowledge that such actions will have a negative consequence. However, that negative consequence is dismissed by the fear of missing out, or rather F.O.M.O.

As greed overtakes fear, investors become more emboldened as rising markets reinforce the conviction that this time is different. Ultimately, when the negative consequence eventually occurs, instead of taking responsibility for their actions, they blame the media, Wall Street, or their advisor.

This currently where we are in the markets today.

Investors know there is a rising risk of loss, but, they are willfully ignoring the facts and and piling into risk because the narrative has simply become fundamentals dont matter. In 2020, investors are again chasing growth at any price and rationalizing overpaying for growth.

Such makes the mantra of using 24-month estimates to justify paying exceedingly high valuations today, even riskier.

This is also where there is the greatest disparity between growth and value on record.

There are two critical takeaways from the graph above:

In other words, there is high probability that investors chasing growth are going to pay a heavy price in the future..

The problem, as discussed in Insanely Stupid, the ability for stocks to continue to grow earnings at a rate to support high valuations will be problematic. Such is due to rising debts and deficits which will retard economic growth in the future. To wit:

Before the Financial Crisis, the economy had a linear growth trend of real GDP of 3.2%. Following the 2008 recession, the growth rate dropped to the exponential growth trend of roughly 2.2%. Instead of reducing the debt problems, unproductive debt, and leverage increased.

The COVID-19 crisis led to a debt surge to new highs. Such will result in a retardation of economic growth to 1.5% or less.

Slower economic growth, combined with a potential for higher taxes, increases the probability that risk may well outweigh reward at this juncture.

Such doesnt mean that stocks cant go higher in the near term, and despite some wiggles along the way, it is quite likely they will simply because of momentum and lots of bullish bias.

Weve often noted that during times of unhealthy market environments, when fewer than 60% of stocks can hold above their 200-day averages, that periods of high optimism tend to lead to below-average forward returns.

Were seeing that now, to a historic degree. Since weve been tracking this data, just over 20 years, there has never been a day when Dumb Money Confidence was at or above 80% while fewer than 60% of stocks in the S&P 500 were trading above their 200-day averages. Until now. Sentiment Trader

The problem of eternal bullishness is it leads to the willful blindness of risks, rather than having a healthy respect for, and recognition of, those risks. This leads to the unfortunate problem of being all-in on every hand which has a devastating consequence when a mean reverting event occurs.

Our job as investors is to navigate the waters within which we currently sail, not the waters we think we will sail in later. Higher returns come from the management of risks rather than the attempt to create returns by chasing markets.

I recently quoted Robert Rubin, former Secretary of the Treasury, in This Is Nuts, as it defined our philosophy on risk.

As I think back over the years, I have been guided by four principles for decision making. The only certainty is that there is no certainty. Second, every decision, as a consequence, is a matter of weighing probabilities. Third, despite uncertainty, we must decide and we must act. And lastly, we need to judge decisions not only on the results but also on how we made them.

Most people are in denial about uncertainty. They assume theyre lucky, and that the unpredictable can be reliably forecasted. Such keeps business brisk for palm readers, psychics, and stockbrokers, but its a terrible way to deal with uncertainty. If there are no absolutes, all decisions become matters of judging the probability of different outcomes, and the costs and benefits of each. Then, on that basis, you can make a good decision. Robert Rubin

It should be evident that an honest assessment of uncertainty leads to better decisions.

The problem with Eternal Bullishness and Willful Blindness is that the failure to embrace uncertainty increases risk, and ultimately loss.

We must be able to recognize and be responsive to changes in underlying market dynamics. If they change for the worse, we must be aware of the inherent risks in portfolio allocation models. The reality is that we cant control outcomes. The most we can do is influence the probability of specific outcomes.

Focusing on risk not only removes willful blindness from the process, it is essential to capital preservation and investment success over time.

Original post

Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.

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Blind teen captivates social media with reading and writing lesson: ‘This blows my mind’ – Yahoo Sports

August 13th, 2020 7:50 pm

A British TikToker has captivated social media with a simple explanation of how she both creates and consumes online content as a blind person.

Gracie Marsh, a 19-year-old disability advocate from England who went blind at age 14 due to Septo-optic dysplasia, shared a now-viral video on July 28 explaining how she operates her BrailleNote HumanWare Touch+.

Marsh demonstrates how the tablet, which allows those with visual impairments to read and write with ease, functions as she walks viewers through the keyboards nine main buttons the backspace, enter and space bars, as well as the six keys representing the six dots that make up the braille system.

The device also comes equipped with a touchscreen, which Marsh says is particularly useful for teachers and sighted peers.

Her insightful video has since racked up over 1.5M views on TikTok alone, plus 2.2M more on Twitter, along with tons of comments from viewers who were utterly impressed with the technology.

This is [a] true technological masterpiece! wrote one user.

This was really interesting to learn! Thanks for sharing with us, commented another.

This blows my mind, said a third.

Marsh, who was born with multiple chronic illnesses that have caused her to need a wheelchair, feeding tube and catheter, told In The Know that she started making TikToks for entertainment earlier this year before pivoting into disability awareness content after one of her videos went viral with over 450K views in June.

[A TikTok] where I did my makeup as a blind person kind of blew up, so I decided totry and build a bigger platform, Marsh, who now boasts over 28K followers, told In The Know.

With content ranging from rating her main diagnoses to how she uses an iPhone to how she dreams, Marsh says that her videos have been generally well-received.

She does, however, still occasionally get nasty or misinformed comments, including some that allege shes faking her condition.

Its been really positive overall, but I have received some comments questioning my blindness, she told In The Know. How are you blind if youre reading these comments? et cetera, even though thats been explained in many of my TikToks!

Ultimately, Marsh hopes that her informative and often humorous videos can serve to dispel stigmas surrounding the visually impaired and show the world exactly what shes capable of.

I think Id just like people to know that blindness, and disability in general, doesnt mean that individuals cant advocate for themselves, participate in normal activities and be independent, she said. Id like people to stop underestimating me and the disabled community as a whole!

These are the best tech gifts under $100:

If you enjoyed this article, read about TikToker Chrissy Marshall, who uses her experience as a deaf woman to educate millions.

More from In The Know:

Starbucks is opening its first sign language store in Japan

Deaf, transgender model Chella Man shares how to be a better ally for people with disabilities

Netflixs new show, Love on the Spectrum, highlights the dating lives of people with autism

Blind skateboarder Ryusei Ouchi has never let his disability hold him back

The post Teen reveals how shes able to read and type as a blind person appeared first on In The Know.

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Blind teen captivates social media with reading and writing lesson: 'This blows my mind' - Yahoo Sports

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Ocugen Receives Fourth FDA Orphan Drug Designation for the Same Product, OCU400 (AAV-NR2E3) Gene Therapy, for the Treatment of Another Key Inherited…

August 13th, 2020 7:50 pm

MALVERN, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases, today announced the U.S. Food and Drug Administration (FDA) granted the fourth Orphan Drug Designation (ODD) for OCU400 in the treatment of PDE6B gene mutation-associated retinal diseases. Retinitis Pigmentosa (RP) caused by PDE6B mutation is an inherited retinal dystrophy that leads to blindness by midlife and is characterized by the progressive loss of photoreceptors, with or without the loss of retinal pigment epithelium cells. At least one mutation in the PDE6B gene has been found to cause autosomal dominant congenital stationary night blindness, which is characterized by the inability to see in low light.

Ocugens Modifier Gene Therapy Platform offers a unique approach in ophthalmology by addressing multiple diseases with a single product. A novel gene therapy product candidate, OCU400 has the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse inherited retinal diseases. It consists of a functional copy of a nuclear hormone receptor (NHR) gene, NR2E3, delivered to target cells in the retina using an adeno-associated viral vector. As a potent modifier gene, expression of NR2E3 within the retina may help reset retinal homeostasis and potentially offer longer benefit, stabilizing cells and rescuing photoreceptor degeneration and vision loss. In pre-clinical studies, OCU400 has demonstrated improved vision signals in the retina where Electroretinogram response reveals rescue under both Scotopic (dim-lit) as well as Photopic (well-lit) conditions. The Company believes targeting multiple diseases with one product could also offer a smoother regulatory pathway and the ability to recover development costs over multiple therapeutic indications. Ocugen is planning to initiate two parallel Phase I/II clinical trials next year targeting two unique IRDs.

Following up on recent announcement of an ODD for RHO mutation-associated retinal degeneration and previous ODDs for both NR2E3 and CEP290 mutation-associated retinal degeneration, the ODD for PDE6B gene mutation-associated retinal degeneration continues to support Ocugens breakthrough modifier gene therapy platforms potential to treat multiple blindness diseases with a single product. RP is a group of heterogenic inherited retinal diseases associated with over 150 gene mutations, affecting over 1.5 million individuals worldwide. In addition, ~40% of RP patients cannot be genetically diagnosed, confounding the ability to develop personalized RP therapies. Traditional gene therapy or gene editing approaches may require more than 150 products to rescue these patients from vision loss. OCU400, a single product candidate, has potential to address broad-spectrum RP.

As principal investigator of numerous major clinical trials developing new medical and surgical treatments for retinal disorders, I have been on the cutting-edge of many new ophthalmology treatments. I am very encouraged by the potential for OCU400 given the uniqueness of Ocugens Modifier Gene Therapy Platform and the fact that FDA has issued four ODDs for this product. I look forward to Ocugen commencing clinical trials for OCU400 next year and the potential of helping patients by restoring retinal integrity and function across a range of genetically diverse inherited retinal diseases including broad-spectrum RP, said Carl D. Regillo, M.D.,F.A.C.S., member of Ocugens Retina Scientific Advisory Board and Professor of Ophthalmology at the Sidney Kimmel Medical College at Thomas Jefferson University, Chief of the Retina Service at Wills Eye Hospital and founder and former director of the Wills Eye Clinical Retina Research Unit in Philadelphia.

I am thrilled to announce our fourth ODD for OCU400 from the FDA after announcing our third ODD for RHO mutation-associated retinal degeneration just a few days ago. With no approved treatments that slow or stop the progression of RP, we are dedicated to driving the development of our Modifier Gene Therapy Platform forward and potentially addressing the unmet need of multiple gene mutations, including mutations in the PDE6B gene with only one product, said Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen.

The FDA Office of Orphan Products Development grants orphan designation for novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including a seven-year period of U.S. marketing exclusivity, tax credits for clinical research costs, clinical research trial design assistance, the ability to apply for annual grant funding and waiver of Prescription Drug User Fee Act filing fees.

About OCU400OCU400 (AAV-hNR2E3) is a novel gene therapy product candidate with the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse inherited retinal diseases. It consists of a functional copy of a nuclear hormone receptor gene, NR2E3, delivered to target cells in the retina using an adeno-associated viral vector. As a potent modifier gene, expression of NR2E3 within the retina may help reset retinal homeostasis, potentially stabilizing cells and rescuing photoreceptor degeneration and vision loss.

About Ocugen, Inc.Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug one to many and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. For more information, please visit https://ocugen.com/.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the SEC), including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Corporate Contact:Ocugen, Inc.Sanjay SubramanianChief Financial OfficerIR@Ocugen.com

Media Contact:LaVoieHealthScienceEmmie Twomblyetwombly@lavoiehealthscience.com+1 857-389-6042

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