Foundations
Here's a look at documents from U.S. foundations
Featured Stories
TPPF Supports Texas Supreme Court Determination of Law School Accreditation
AUSTIN, Texas, July 3 -- The Texas Public Policy Foundation issued the following news release on July 2, 2025:
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TPPF Supports Texas Supreme Court Determination of Law School Accreditation
The Texas Public Policy Foundation (TPPF) submitted its comment to the Texas Supreme Court regarding its authority to delegate law school accreditation to a private entity, specifically the American Bar Association. The comment argues that the current practice is a violation of the private non-delegation doctrine.
The Texas Legislature delegated the responsibility of licensing attorneys to the Supreme
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AUSTIN, Texas, July 3 -- The Texas Public Policy Foundation issued the following news release on July 2, 2025:
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TPPF Supports Texas Supreme Court Determination of Law School Accreditation
The Texas Public Policy Foundation (TPPF) submitted its comment to the Texas Supreme Court regarding its authority to delegate law school accreditation to a private entity, specifically the American Bar Association. The comment argues that the current practice is a violation of the private non-delegation doctrine.
The Texas Legislature delegated the responsibility of licensing attorneys to the SupremeCourt of Texas and was clear that this authority "may not be delegated" further. However, since 1983, the Court has allowed the American Bar Association to determine the law schools from which one must graduate to be eligible to practice law in Texas. It is time to return that authority to where it belongs.
"We applaud the Court for reconsidering its accreditation practices," said TPPF executive director and general counsel Robert Henneke. "It is time to reclaim the constitutionally mandated duty to decide what is necessary for law schools to meet Texas' standards."
TPPF director of litigation Chance Weldon added, "Standards for Texas law schools should be set by a body elected by Texans, not a private entity in Illinois."
To read the comment, click here (https://www.texaspolicy.com/wp-content/uploads/2025/07/2025.07.01-SCOTX-ABA-Comment.pdf).
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Original text here: https://www.texaspolicy.com/press/tppf-supports-texas-supreme-court-determination-of-law-school-accreditation
Leber Congenital Amaurosis Research Advances
COLUMBIA, Maryland, July 3 -- The Foundation Fighting Blindness issued the following news:
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Leber Congenital Amaurosis Research Advances
Recent developments in research on Leber congenital amaurosis.
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LCA4 GENE THERAPY RESTORES MEANINGFUL VISION FOR BLIND CHILDREN
MeiraGTx, a genetic medicines company in New York and London, has reported significant vision improvements for 11 children, between the ages of one and four, who received a gene therapy for Leber congenital amaurosis 4 (LCA4), a severe retinal condition caused by mutations in the gene AIPL1. Results for four children in a
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COLUMBIA, Maryland, July 3 -- The Foundation Fighting Blindness issued the following news:
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Leber Congenital Amaurosis Research Advances
Recent developments in research on Leber congenital amaurosis.
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LCA4 GENE THERAPY RESTORES MEANINGFUL VISION FOR BLIND CHILDREN
MeiraGTx, a genetic medicines company in New York and London, has reported significant vision improvements for 11 children, between the ages of one and four, who received a gene therapy for Leber congenital amaurosis 4 (LCA4), a severe retinal condition caused by mutations in the gene AIPL1. Results for four children in aclinical trial at Great Ormond Street Hospital in London were reported in the journal Lancet. Prof. Michel Michaelides from Moorfield's Eye Hospital and University College London was lead investigator for the clinical trial and lead author on the Lancet paper. MeiraGTx hopes to apply for marketing approval in the UK for its LCA4 gene therapy.
THEA LAUNCHES SEPUL BIO TO ADVANCE LCA10 AND USH2A RNA (ANTISENSE OLIGONUCLEOTIDE) THERAPY
Thea has launched a new business unit, Sepul Bio, to continue clinical development of two RNA therapies: sepofarsen for people with LCA10 caused by the IVS26 mutation in the CEP290 gene and ultevursen for people with exon 13 mutations in the USH2A gene. Both therapies, originally developed by ProQR, had shown efficacy in earlier clinical trials. In December 2024, SepulBio announced that it had dosed the first patient in its LUNA Phase 2b clinical trial for ultevursen. Details on the clinical trial for sepofarsen are forthcoming.
OPUS GENETICS REPORTS VISION IMPROVEMENTS IN LCA5 GENE THERAPY CLINICAL TRIAL
Opus Genetics, a patient-focused gene therapy company launched by the Foundation, has merged with Ocuphire. The new company retains the Opus name and is traded on the NASDAQ exchange with the symbol "IRD."Opus reported vision improvements patients in its Phase 1/2 gene therapy clinical trial underway at the University of Pennsylvania for people with LCA5. Some of the patients, who had been almost totally blind since birth, can now see and identify objects for the first time. The company plans to enroll pediatric patients in the trial during the first quarter of 2025. LCA5 is one of the most severe forms of LCA.
GENE THERAPY FOR LCA1 (GUCY2D) IMPROVES VISION IN CLINICAL TRIAL, PHASE 3 TRIAL PLANNED
Atsena has licensed its LCA1 (GUCY2D) gene therapy to Nippon Shinyaku for potential marketing in the US and EU. A Phase 3 clinical trial is planned. In the Phase 1/2 clinical trial for the LCA1 gene therapy, the nine patients receiving the highest dose had improvements in retinal sensitivity and their ability to navigate a low-luminance mobility course. The treatment was developed by Shannon Boye, PhD, at the University of Florida, and an Atsena co-founder.
GENE THERAPY FOR LCA6 (RPGRIP1 MUTATIONS)
Odylia is developing a gene therapy based on an adeno-associated virus for LCA caused by RPGRIP1 mutations. Future plans include generating a clinical-grade gene-therapy vector for toxicology studies, and ultimately, a clinical trial. Dr. Eric Pierce's clinic at Mass Eye and Ear has also identified seven families with RPGRIP1 mutations. An earlier study showed that gene therapy rescued degenerating rods and cones in a mouse model of the condition.
FDA APPROVES SPARK'S VISION-RESTORING GENE THERAPY
Spark Therapeutics' vision-restoring RPE65 gene therapy has received marketing approval from the U.S. Food and Drug Administration, becoming the first gene therapy to gain regulatory approval in the U.S. for the eye or any inherited condition. Known as LUXTURNA(TM) (voretigene neparvovec), the gene therapy restored vision in a clinical trial for people between the ages of 4 and 44 with Leber congenital amaurosis (LCA) caused by mutations in the gene RPE65. Study participants with severe vision loss reported putting away their navigational canes, seeing stars, being able to read, and recognizing faces of loved ones. Vision restoration has persisted for at least three years. The treatment is also designed to work for people with retinitis pigmentosa (RP) caused by RPE65 mutations. The Foundation invested about $10 million in more than a decade of lab research that made possible the RPE65 gene therapy clinical trial at the Children's Hospital of Philadelphia (CHOP).
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Original text here: https://www.fightingblindness.org/news/leber-congenital-amaurosis-research-advances-861
IMF Proudly Announces EMA-CHMP Positive Qualification Advice to I2TEAMM Novel Biomarker Procedure Application on Use of MRDnegCR as Intermediate Early Endpoint for Conditional Market Approval in Myeloma Clinical Trials
STUDIO CITY, California, July 3 -- The International Myeloma Foundation issued the following news:
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The IMF Proudly Announces EMA-CHMP Positive Qualification Advice to i2TEAMM Novel Biomarker Procedure Application on the Use of MRDnegCR as an Intermediate Early Endpoint for Conditional Market Approval in Myeloma Clinical Trials
Another Remarkable Milestone for the IMF and i2TEAMM, Following the FDA-ODAC Unanimous 12-0 Vote in April 2024
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The International Myeloma Foundation (IMF) and the collaborative stakeholder group i2TEAMM (International Independent Team for Endpoint Approval of
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STUDIO CITY, California, July 3 -- The International Myeloma Foundation issued the following news:
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The IMF Proudly Announces EMA-CHMP Positive Qualification Advice to i2TEAMM Novel Biomarker Procedure Application on the Use of MRDnegCR as an Intermediate Early Endpoint for Conditional Market Approval in Myeloma Clinical Trials
Another Remarkable Milestone for the IMF and i2TEAMM, Following the FDA-ODAC Unanimous 12-0 Vote in April 2024
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The International Myeloma Foundation (IMF) and the collaborative stakeholder group i2TEAMM (International Independent Team for Endpoint Approval ofMyeloma MRD), which includes top global myeloma experts, proudly announce the positive outcome of the i2TEAMM's application on the use of minimal residual disease (MRD) as an early endpoint in myeloma clinical trials. Building on the tremendous success and momentum gained from the 12-0 unanimous vote given by the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) in April 2024, the i2TEAMM submitted an application (Doc Ref: EMADOC-360526170-2374344) to the EMA-CHMP on November 15, 2024, regarding the use of MRD "as an early endpoint in clinical trials conducted in patients with multiple myeloma in order to support regulatory decisions." The CHMP, as the European Medicines Agency's (EMA's) committee, plays a central role in the scientific evaluation of marketing authorization applications for medicines for human use.
In a scientific advice letter, the CHMP stated: "On 5/22/2025, the CHMP met and adopted the advice to be given to the applicant. CHMP agrees that, depending on the setting, a role for MRDnegCR as an endpoint to support (conditional) approval of a compound while the obligation to demonstrate long-term benefit remains, can be envisaged. This implies that the trials should be adequately planned to demonstrate a benefit in PFS or OS."
IMF Chairperson of the Board S. Vincent Rajkumar, MD, said: "I am very pleased with the CHMP opinion that MRD can be considered as a potential early endpoint for conditional approval of treatments in myeloma. This is great news for the field and is in line with a similar recommendation by ODAC in the United States. We are an international organization, and we are committed to accelerating the availability of effective new treatments to myeloma patients worldwide. I applaud the efforts of the i2TEAMM investigators and our entire team at the International Myeloma Foundation."
"The acceptance of the IMF/ i2TEAMM application by the EMA-CHMP represents one of the most significant milestones in our collective mission to accelerate innovation and cure in multiple myeloma. Recognizing MRD as a valid early endpoint brings us one step closer to delivering more timely, effective therapies to patients. This scientific advancement reflects the strength of global collaboration and data-driven progress in the field," said Nikhil Munshi, MD (Dana-Farber Cancer Institute -- Boston, MA), a member of the i2TEAMM Executive Committee, the IMF Scientific Advisory Board, and the IMF Board of Directors.
Jesus San Miguel, MD, PhD (University of Navarra -- Pamplona, Spain), who is also a member of the i2TEAMM Executive Committee and the IMF Scientific Advisory Board, praised the EMA-CHMP's decision and said: "This was the result of a long-standing effort of the International Myeloma Foundation, Academic Centers, and Industry that worked together under the umbrella of the i2TEAMM project. The new MRD endpoint will represent a sensitive early readout for conditional drug approval, allowing patients timely access to newer treatment options although trials should be adequately planned to demonstrate a benefit in PFS or OS."
"The International Myeloma Foundation is elated at the groundbreaking outcomes of the i2TEAMM's efforts, both in the FDA-ODAC and the EMA-CHMP. As these remarkable milestones bring us closer to a cure, we look forward to a future where the IMF's vision can finally be achieved: A world where every myeloma patient can live life to the fullest, unburdened by the disease," said IMF Interim CEO and Senior VP of Strategic Planning Diane Moran, RN, MA, EdM.
ABOUT THE INTERNATIONAL MYELOMA FOUNDATION
Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest global foundation focusing specifically on multiple myeloma. The Foundation's reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative(R), a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org.
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Original text here: https://www.myeloma.org/news-events/multiple-myeloma-news/imf-proudly-announces-ema-chmp-positive-qualification-advice-i2teamm-novel-biomarker-procedure
Researchers Evaluate Branched-Chain Amino Acid Interaction on Layer Production and Performance
TUCKER, Georgia, July 2 (TNSrep) -- The U.S. Poultry Foundation issued the following news release:
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Researchers Evaluate Branched-Chain Amino Acid Interaction on Layer Production and Performance
USPOULTRY and the USPOULTRY Foundation announce the completion of a funded research project from Mississippi State University on layer hen production and performance. Due to limited resources on the interaction and requirements of lower amino acids in the layer industry, researchers aimed to investigate how branched-chain amino acid interactions affect the performance, feather quality and egg quality
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TUCKER, Georgia, July 2 (TNSrep) -- The U.S. Poultry Foundation issued the following news release:
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Researchers Evaluate Branched-Chain Amino Acid Interaction on Layer Production and Performance
USPOULTRY and the USPOULTRY Foundation announce the completion of a funded research project from Mississippi State University on layer hen production and performance. Due to limited resources on the interaction and requirements of lower amino acids in the layer industry, researchers aimed to investigate how branched-chain amino acid interactions affect the performance, feather quality and egg qualityof laying hens. The research is part of the Association's comprehensive research program encompassing all phases of poultry and egg production and processing and is made possible in part through proceeds from the International Poultry Expo, part of the International Production & Processing Expo.
Project #F-103: Understanding the Influence of Branched-Chain Amino Acid Interaction on Performance, Feather Quality and Egg Quality of Laying Hens
(Dr. Pratima Adhikari, Department of Poultry Science, Mississippi State University, Mississippi State, Miss.)
Feeding low crude protein diets is a well-established strategy to reduce feeding costs, minimize excess nitrogen and waste, and support profitability, animal health, welfare and sustainability in broilers and swine. Dr. Adhikari, associate professor at Mississippi State University, investigated how varying levels of leucine (Leu), valine (Val) and isoleucine (Ile), as well as their interactions, affect pullet performance and bone quality during the grower and developer phases, as well as layer performance and egg quality during the laying phase.
This research is especially relevant for diets containing distillers dried grains with solubles (DDGS) and corn, as corn and its by-products are disproportionately high in Leu compared to Val and Ile. The researcher hypothesized that practical corn-soybean meal-DDGS diets with a high Leu:Lys ratio could create amino acid imbalances, negatively affecting performance, egg weight, feather quality, economic returns and the sustainability of egg production.
The research summary (https://www.uspoultry.org/programs/research/search-abstracts/repository/PROJ_F103.html) can be found on the USPOULTRY website. Information on other Association research may also be obtained by visiting the USPOULTRY website, uspoultry.org.
About USPOULTRY
U.S. Poultry & Egg Association (USPOULTRY) is the All Feather Association progressively serving its poultry and egg members through research, education, communications and technical services.Founded in 1947, USPOULTRY is based in Tucker, Georgia.
About USPOULTRY Foundation
The USPOULTRY Foundation's mission is to support the recruitment and training of the brightest students, seek and fund scientific research, foster student scientists and promote careers in the poultry and egg industry.
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Original text here: https://www.poultryfoundation.org/news/pressRelease.cfm?pid=96D303A5969C024CD6D5B69847A78C38
JED Applauds Senate Rejection of Harmful AI Moratorium Proposal, Urges Congress to Continue Support for Youth Mental Health
NEW YORK, July 2 -- The Jed Foundation issued the following news release:
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JED Applauds Senate Rejection of Harmful AI Moratorium Proposal, Urges Congress to Continue Support for Youth Mental Health
The Jed Foundation (JED) applauds the near-unanimous Senate vote early this morning to adopt Senator Marsha Blackburn's (R-TN) amendment striking a dangerous provision in the "One Big Beautiful Bill" that would have imposed a federal moratorium on state regulation of artificial intelligence (AI). The decisive action rightly preserves states' ability to act swiftly to protect youth from AI systems
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NEW YORK, July 2 -- The Jed Foundation issued the following news release:
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JED Applauds Senate Rejection of Harmful AI Moratorium Proposal, Urges Congress to Continue Support for Youth Mental Health
The Jed Foundation (JED) applauds the near-unanimous Senate vote early this morning to adopt Senator Marsha Blackburn's (R-TN) amendment striking a dangerous provision in the "One Big Beautiful Bill" that would have imposed a federal moratorium on state regulation of artificial intelligence (AI). The decisive action rightly preserves states' ability to act swiftly to protect youth from AI systemsthat are developmentally inappropriate, exploitative, or manipulative.
"At a time when AI is increasingly shaping the environments where children and young adults learn, socialize, and seek support, it is essential that governments at every level retain the power to act to curb the potential dangers that AI poses for youth," said Dr. Zainab Okolo, Senior Vice President of Policy, Advocacy, and Government Relations at JED. "A federal moratorium would have undermined critical state efforts to respond to emerging harms and implement urgently needed safeguards and accountability measures."
This 99-1 bipartisan action sends a clear message: Protecting the mental health and well-being of children must be our top priority.
JED strongly supports federal action to protect youth online, including the Kids Online Safety Act (KOSA), which would establish critical safety standards for online platforms and the AI systems embedded within them, and the development of a federal data privacy framework that addresses algorithmic profiling, opaque recommendation systems, and manipulative AI design. But until such protections are fully enacted and enforced, states must retain the authority to create applicable guardrails for AI that protect youth from harm, promote emotional well-being, and ensure accountability wherever AI is deployed. (Read our latest AI policy recommendations here.)
As Congress considers final passage of the "One Big Beautiful Bill," we urge lawmakers to keep the safety and best interests of children at the center - and to reject policies that would weaken access to Medicaid and the mental health services young people rely on.
JED stands ready to work with both state and federal leaders to ensure our policies are prioritizing youth mental health and providing the protections and supports that young people need and deserve. We continue to advocate for specific protective policies to meet this moment.
About The Jed Foundation (JED)
JED is a nonprofit that protects emotional health and prevents suicide for our nation's teens and young adults. We're partnering with high schools, colleges, and school districts to strengthen their mental health, substance misuse, and suicide prevention programs and systems. We're equipping teens and young adults with the skills and knowledge to help themselves and each other. We're encouraging community awareness, understanding, and action for young adult mental health.
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Original text here: https://jedfoundation.org/jed-applauds-senate-rejection-of-harmful-ai-moratorium-proposal-urges-congress-to-continue-support-for-youth-mental-health/
FDA Eliminates REMS Program for Certain Autologous CAR T-Cell Therapies
NORTH HOLLYWOOD, California, July 2 -- The International Myeloma Foundation issued the following news:
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FDA Eliminates REMS Program for Certain Autologous CAR T-cell Therapies
FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) Program for Certain Autologous CAR T-cell Therapies
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According to this press release from the U.S. Food and Drug Administration, "The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T
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NORTH HOLLYWOOD, California, July 2 -- The International Myeloma Foundation issued the following news:
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FDA Eliminates REMS Program for Certain Autologous CAR T-cell Therapies
FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) Program for Certain Autologous CAR T-cell Therapies
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According to this press release from the U.S. Food and Drug Administration, "The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR Tcell immunotherapies."
"These products are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma."
The press release noted, "The FDA determined that the approved REMS for the following products should be eliminated because a REMS is no longer necessary to ensure that the benefits of the autologous CAR T cell immunotherapies outweigh their risks.
* Abecma(R) (idecabtagene vicleucel)
* Breyanzi (lisocabtagene maraleucel)
* Carvykti(R) (ciltacabtagene autoleucel)
* Kymriah (tisagenlecleucel)
* Tecartus (brexucabtagene autoleucel)
* Yescarta (axicabtagene ciloleucel)"
Hospitals and clinics no longer need special certification or on-site access to tocilizumab to give these treatments. Safety information--such as the risk of cytokine release syndrome and neurological side effects--will now be shared through the product's label and medication guide.
These therapies will still be closely monitored. Manufacturers are still required to report side effects and conduct long-term safety studies for at least 15 years after treatment.
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Original text here: https://www.myeloma.org/news-events/multiple-myeloma-news/fda-eliminates-REMS-car-t-cell-therapies
Age-Related Macular Degeneration Research Advances
COLUMBIA, Maryland, July 2 -- The Foundation Fighting Blindness issued the following news:
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Age-Related Macular Degeneration Research Advances
Recent developments in research on age-related macular degeneration.
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LUXA REPORTS VISION IMPROVEMENTS IN CLINICAL TRIAL OF RPE STEM CELLS FOR DRY AMD
Luxa Biotechnology reported encouraging results for six patients with dry AMD receiving a low dose (50,000 cells) of RPESC-RPE-4W, its proprietary retinal pigment epithelial stem cell therapy, in a Phase 1/2a clinical trial. Thanks to these results, the company has begun dosing patients with a
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COLUMBIA, Maryland, July 2 -- The Foundation Fighting Blindness issued the following news:
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Age-Related Macular Degeneration Research Advances
Recent developments in research on age-related macular degeneration.
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LUXA REPORTS VISION IMPROVEMENTS IN CLINICAL TRIAL OF RPE STEM CELLS FOR DRY AMD
Luxa Biotechnology reported encouraging results for six patients with dry AMD receiving a low dose (50,000 cells) of RPESC-RPE-4W, its proprietary retinal pigment epithelial stem cell therapy, in a Phase 1/2a clinical trial. Thanks to these results, the company has begun dosing patients with ahigher dose of 150,000 cells. The three patients with worse vision in the clinical trial responded best to Luxa's emerging RPE stem cell treatment. Their average best corrected visual acuity (BCVA) was approximately 32 letters (slightly better than 20/250) upon enrollment. At 12 months after receiving RPESC-RPE-4W, their vision improved an average of 21.67 letters to about 20/80. The RPESC-RPE-4W cell product is derived from adult human RPE stem cells that haven't quite become mature RPE cells but whose fate is determined to produce RPE.
NUTRITIONAL SUPPLEMENT REDUCES RISK OF ADVANCED AMD
The Age-Related Eye Disease Study (AREDS) -- a landmark investigation conducted by the National Eye Institute (NEI) -- determined that antioxidant supplementation can slow the progression of AMD. The AREDS formulation is an over-the- counter antioxidant supplement recommended for people who are at risk of developing advanced forms of either dry or wet AMD. The formulation includes the antioxidants beta carotene, vitamin E, and vitamin C, as well as the nutrients zinc and copper.
The NEI recently completed a second AREDS study (AREDS2) to evaluate the potential benefits of the antioxidants lutein and zeaxanthin and the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The results of AREDS2 showed that DHA and EPA did not confer additional benefit in reducing AMD risk. The researchers from AREDS2 did recommend that beta carotene in the original formula be replaced with lutein, because beta carotene can increase lung cancer risk in current and former smokers. For more information on the AREDS2 study, visit www.areds2.org.
A new analysis of data from the National Eye Institute's (NEI) Age-Related Eye Disease Studies (AREDS and AREDS2) has shown that the AREDS nutritional supplements slowed the progression of geographic atrophy (GA), the late-stage of dry age-related macular degeneration (AMD) which is also known as geographic atrophy (GA). For the majority in AREDS and AREDS2 who developed GA far from the fovea, the supplements slowed the rate of GA expansion towards the fovea by approximately 55 percent over an average of three years.
GENENTECH'S SUSVIMO (PORT DELIVERY SYSTEM) REDCUES TREATMENT BURDEN FOR WET AMD
Genentech's Susvimo, a permanent, refillable implant the size of a rice grain, provides continual delivery of an anti-VEGF treatment to the retina. In a Phase 3 clinical trial, a single PDS implant performed as effectively as six-monthly injections of Lucentis(R) (an FDA-approved anti-VEGF therapy). The PDS continually delivered a customized formulation of Lucentis for six months without being refilled. The primary outcome measure for the Phase 3 clinical trial was change in best-corrected visual acuity (measured by reading letters on an eye chart). Susvimo greatly reduces the burden of regular injections to treat wet AMD.
GENENTECH'S WET AMD TREATMENT VABYSMO IS INJECTED ONCE EVERY FOUR MONTHS
Genentech, a global biotechnology company and member of the Roche Group, has shown that VabysmoTM (faricimab-svoa) is effective for for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The treatment is injected into the patient's vitreous, the soft gel in the middle of the eye, as infrequently as every 16 weeks at an eye doctor's office.
EYLEA(TM) PRESERVES VISION IN WET AMD WITH FEWER INJECTIONS
Regeneron's wet AMD treatment, Eylea, blocks the development of unhealthy blood vessels that lead to vision loss. Regeneron reports that in clinical trials, Eylea treated wet AMD as effectively as
Lucentis, but with fewer eye injections. Genentech, maker of Lucentis, recommends monthly injections of their treatment. Regeneron, maker of Eylea, reports that their therapy can be injected every eight weeks after monthly dosing for the first 12 weeks of treatment. Eylea was approved by the FDA in November 2011.
REGENXBIO'S WET AMD GENE THERAPY MOVES INTO PHASE 3 TRIALS
REGENXBIO, a clinical-stage gene therapy biotechnology company, is conducting two pivotal, Phase 3 clinical trials for RGX-314, its gene therapy designed to halt the growth of leaky blood vessels that cause retinal degeneration and central vision loss in people with the wet form of age-related macular degeneration (AMD). In one study, the treatment is delivered via a subretinal injection. In the other trial, it is delivered by a suprachoroidal injection.
APELLIS' SYFOVRE APPROVED BY FDA FOR DRY AMD (GEOGRAPHIC ATROPHY)
The biopharmaceutical company Apellis received FDA approval to market SYFOVRE(R), a treatment for geographic atrophy (GA), the advanced from of dry age-related macular degeneration. Combined results from two Phase 3 clinical trials, DERBY and OAKS, showed that SYFOVRE (pegcetacoplan) reduced the growth rate of atrophic lesions associated with GA geographic atrophy (GA). SYFOVRE was the first treatment available for GA. An overactive complement system, a part of the innate immune system, is implicated in the retinal degeneration associated with AMD. SYFOVRE targets the C3 complement pathway.
ASTELLAS' IZERVAY APPROVED BY FDA FOR ADVANCED DRY AMD (GEOGRAPHIC ATROPHY)
Astellas has received FDA approval for IZERVAY(TM) (avacincaptad pegol) for the treatment of geographic atrophy (GA) secondary to advanced dry age-related macular degeneration. The drug was developed by Iveric Bio, which was acquired by Astellas. The drug, a C5 complement inhibitor, slowed the progression of lesion growth in two Phase 3 clinical trials. An overactive complement system, a part of the innate immune system, is implicated in the retinal degeneration associated with AMD. IZERVAY targets the C5 complement pathway.
OCUGEN LAUNCHES MODIFIER GENE THERAPY CLINICAL TRIAL FOR ADVANCED DRY AMD (GEOGRAPHIC ATROPHY)
Ocugen has initiated a Phase 1/2 clinical trial of OCU-410, a modifier gene therapy designed to slow progression of the growth of lesions associated with geographic atrophy (GA). OCU410 is administered with a single sub-retinal injection that targets multiple pathways causing dAMD, including lipid metabolism, inflammation, oxidative stress, and complement activation.
RETINAL PATCH PERFORMS PROMISINGLY IN CLINICAL TRIAL FOR DRY AMD
Regenerative Patch Technologies, a company developing stem-cell-derived treatments for people with retinal diseases, has reported encouraging results for the first five patients with advanced, dry age-related macular degeneration (AMD) participating in a Phase 1/2a clinical trial for its therapy - a patch comprised of a layer of retinal pigment epithelial (RPE) cells on a synthetic scaffold. One patient in the trial had visual acuity improvement of 17 letters (about 3 lines on an eye chart) in her treated eye. Three patients had vision maintained in their treated eyes. Two had improved fixation. No evidence of safety issues with the treatment was observed.
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Original text here: https://www.fightingblindness.org/news/age-related-macular-degeneration-research-advances-821
