Retinal degeneration

Endogena Therapeutics Receives US FDA Fast Track Designation for EA-2353 for the Treatment of Retinitis Pigmentosa

Retrieved on: 
Monday, February 6, 2023
MBA, Safety, MD, Severe cognitive impairment, IND, Epithelium, Doctor of Philosophy, AMD, Patient, Retinitis pigmentosa, SAN, FDA, Retinal degeneration, Retinal pigment epithelium, US, Ageing, US Foods, IPF, Therapy, Pharmaceutical industry, Ophthalmology, RP

Fast Track is a process designed to enable patients to benefit earlier from important new drugs for serious conditions.

Key Points: 
  • Fast Track is a process designed to enable patients to benefit earlier from important new drugs for serious conditions.
  • This gene-independent treatment approach has significant advantages in RP, which has multiple genetic causes.
  • EA-2353 was granted orphan drug designation by the US FDA in May 2021.
  • This Fast Track designation will enable Endogena Therapeutics to have more frequent communications with the US FDA on the development of EA-2353 and allow more rapid regulatory review of the future new drug application.

Pixium Vision announces peer-reviewed publications demonstrating the potential of the Next Generation PRIMA implant to restore vision at five times higher resolution than current implant

Retrieved on: 
Thursday, January 12, 2023
Diamond, Retinal degeneration, Visual impairment, PRIMA, Severe cognitive impairment, CET, Nature Communications, Stanford University, AMD, Hope, Human, Bipolar, Vance DeGeneres, Patient, Retina, Visual acuity, Journal, Neuron, Nervous system, Pixel, Mnemos EP, RATS, Electrode, Telescopic sight, Television, Medical device, Camera, Dentistry, Ophthalmology

Pixium Vision is developing the second generation of PRIMA implants in collaboration with its long-term academic partner Stanford University.

Key Points: 
  • Pixium Vision is developing the second generation of PRIMA implants in collaboration with its long-term academic partner Stanford University.
  • "Our new second generation PRIMA implant represents a huge leap forward in prosthetic vision and offers a real chance to restore sight close to natural vision in patients blinded by retinal degeneration," said Lloyd Diamond, Chief Executive Officer of Pixium Vision.
  • They are based on the design of the original PRIMA implants, which were also co-developed by Pixium Vision and Stanford University.
  • A resolution of 24mm on the retina corresponds to 5 times higher acuity than the clinical average with the current implant, promising a significant improvement of central vision for many AMD patients.

Opus Genetics Announces Acquisition of the Rights to Two Gene Therapy Product Candidates for Inherited Retinal Diseases

Retrieved on: 
Wednesday, December 28, 2022
Ghent University Hospital, Severe cognitive impairment, Therapy, RESEARCH, Medical genetics, Louise Ivers, AAV, Ghent University, Epithelium, Retinal pigment epithelium, BEST1, Division, IRDS, Growth, Patient, Raymond, Retina, Genetics, Retinal degeneration, PARK, Doctor of Philosophy, Pharmaceutical industry, MD, EU, Opus, Ophthalmology, IND

RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first, clinical-stage gene therapy company developing treatments for inherited retinal diseases, today announced it has acquired the rights to two preclinical-stage AAV-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio. Opus will develop the novel gene therapy candidates to address bestrophin-1 (BEST1)-related inherited retinal diseases and rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), respectively.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first, clinical-stage gene therapy company developing treatments for inherited retinal diseases, today announced it has acquired the rights to two preclinical-stage AAV-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio.
  • Opus will develop the novel gene therapy candidates to address bestrophin-1 (BEST1)-related inherited retinal diseases and rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), respectively.
  • The BEST1 gene therapy is designed to deliver a functional copy of the BEST1 gene to retinal pigment epithelial cells to produce bestrophin-1 protein and normalize homeostasis between the photoreceptors and retinal pigment epithelial cells.
  • Iveric retains certain rights with respect to the potential future commercialization of gene therapy products for BEST1 and/or RHO-adRP under certain circumstances.

Pixium Vision announces completion of implantations in the European pivotal trial PRIMAvera and confirms target read-out around the end of 2023 and regulatory submission in Europe in H1 2024

Retrieved on: 
Thursday, December 15, 2022
Diamond, Primavera, Physician, AMF, Geographic atrophy, Mnemos EP, Vance DeGeneres, AMD, Rehabilitation, LogMAR chart, IMO, CET, Safety, PRIMA, EN, Moorfields Eye Hospital, Vision Institute, Visual acuity, Stanford University, Risk, Peripheral vision, University of Pittsburgh School of Medicine, Research, Wilfrid Sellars, University, Retinal degeneration, Patient, Prima, UPMC, Medical device, Medical imaging, Pharmaceutical industry

A total of 38 patients have been implanted with the Prima System in the PRIMAvera study (NCT04676854), an open-label, baseline-controlled, non-randomized, multi-center, prospective, single-arm pivotal trial.

Key Points: 
  • A total of 38 patients have been implanted with the Prima System in the PRIMAvera study (NCT04676854), an open-label, baseline-controlled, non-randomized, multi-center, prospective, single-arm pivotal trial.
  • The study is being conducted in leading clinical centers in France, Germany, the UK, the Netherlands, and Italy.
  • A read-out of the PRIMAvera study's primary endpoints is expected around the end of 2023.
  • Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy.

Global Vision Care Market to Reach $85.69 Million by 2028 at a 3.7% CAGR - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 7, 2022
Health, Optical, Paragon, VPS, Primary, Lens (anatomy), Food, Cataract, Analysis, Regulation of tobacco by the U.S. Food and Drug Administration, Retinal degeneration, Joint Medical Service (Germany), Prevalence, Retinal detachment, FDA, Orthokeratology, Glaucoma, Personal computer, Computer vision syndrome, Reading, Conjunctivitis, Marketing, Electronics, Distribution, USD, Market share, Retail, Health insurance

The "Global Vision Care Market, By Product, By Distribution Channel & By Region- Forecast and Analysis 2022-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Vision Care Market, By Product, By Distribution Channel & By Region- Forecast and Analysis 2022-2028" report has been added to ResearchAndMarkets.com's offering.
  • Global Vision Care Market was valued at USD 66.45 Million in 2021, and it is anticipated to attain a value of USD 85.69 Million by 2028, at a CAGR of 3.7% over the prediction period (2022 - 2028).
  • Top-down and bottom-up approaches were used to estimate and validate the size of the Global Vision Care Market and to estimate the size of various other dependent submarkets.
  • The market for vision care products is expected to grow dramatically as the world continues its shift toward digitization.

Opus Genetics Receives FDA Clearance of IND Application for OPGx-001, a Gene Therapy Candidate Intended for the Treatment of Rare Inherited Retinal Disease LCA5

Retrieved on: 
Thursday, December 1, 2022
Triangle Park (Quezon City), Severe cognitive impairment, Science, PARK, Food, Retina, LCA5, IND, Safety, Genetics, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, IPSC, Disease, Leber congenital amaurosis, Foundation Fighting Blindness, Retinal degeneration, LCA, AAV, RESEARCH, FDA, Pharmaceutical industry, Opus

RESEARCH TRIANGLE PARK, N.C., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first, clinical-stage gene therapy company developing treatments for inherited retinal diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1/2, first-in-human clinical trial of OPGx-001 in patients with Leber congenital amaurosis (LCA) resulting from biallelic mutations in the LCA5 gene (LCA5). OPGx-001 is an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5 gene to retinal photoreceptors. Currently, there are no approved treatments for individuals with LCA5-related vision loss.

Key Points: 
  • OPGx-001 is an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5 gene to retinal photoreceptors.
  • This FDA clearance of our IND application for OPGx-001 for LCA5 marks a significant milestone for Opus, as our first program to enter the clinic, said Ben Yerxa, Ph.D., Chief Executive Officer of Opus.
  • OPGx-001 utilizes an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5 gene to photoreceptors in the retina.
  • Opus Genetics is a clinical-stage gene therapy company for inherited retinal diseases with a unique model and purpose.

Pixium Vision announces participation in investor conferences in November and December 2022

Retrieved on: 
Tuesday, November 15, 2022
Diamond, OIS, UPMC, Carousel, University, EN, Mnemos EP, Showcase, La Salle, Patient, IMO, Rehabilitation, CET, Risk, LSX, Research, Retinal degeneration, Vision Institute, Vance DeGeneres, Stanford University, Moorfields Eye Hospital, AMF, Financial services, Management

Lloyd Diamond, Chief Executive Officer, and Offer Nonhoff, Chief Financial Officer, will attend in person and host investor meetings.

Key Points: 
  • Lloyd Diamond, Chief Executive Officer, and Offer Nonhoff, Chief Financial Officer, will attend in person and host investor meetings.
  • Pixium Vision management team members will be present at booth number 112 demonstrating the Prima System.
  • Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy.
  • Pixium Visions bionic vision systems are associated with a surgical intervention and a rehabilitation period.

Opus Genetics Sponsors Uni-Rare Natural History Study for People with Inherited Retinal Diseases

Retrieved on: 
Monday, November 14, 2022
AAV, Retinal degeneration, PARK, Severe cognitive impairment, RESEARCH, Ophthalmology, RDH12, Retina, Science, Triangle Park (Quezon City), Research, IRDS, Retinal dehydrogenase, IRD, Visual impairment, Natural history, Organization, Genetics, Gene, Patient, Pharmaceutical industry, Opus

RESEARCH TRIANGLE PARK, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first gene therapy company developing treatments for inherited retinal diseases, today announced the company will co-sponsor the Uni-Rare Study, a new natural history study for approximately 1,500 people with mutations in one of more than 300 rare genes associated with inherited retinal diseases (IRDs).

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Opus Genetics, a patient-first gene therapy company developing treatments for inherited retinal diseases, today announced the company will co-sponsor the Uni-Rare Study, a new natural history study for approximately 1,500 people with mutations in one of more than 300 rare genes associated with inherited retinal diseases (IRDs).
  • Opus is building a strong portfolio of programs focused on treating genetic mutations that cause inherited retinal diseases.
  • The natural history data collected as part of the Foundations Uni-Rare Study, a first of its kind in retinal diseases, will be critical to the future research and development of new therapies for inherited retinal diseases.
  • Opus Genetics is a groundbreaking gene therapy company for inherited retinal diseases with a unique model and purpose.

Nacuity Pharmaceuticals Expands Board of Directors with Appointment of Dr. Russell Kelley

Retrieved on: 
Tuesday, November 8, 2022
Opus, GLOBE, RD, Duke University, Investment, Eye, Burroughs Wellcome Fund, Retina, Foundation, Cystinosis, Retinal degeneration, Retinitis pigmentosa, Foundation Fighting Blindness, Visual impairment, Science, Gaps, MBA, Cataract, CEO, Oxidative stress, Pharmaceutical industry

FORT WORTH, Texas, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Nacuity Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts, and other ocular diseases caused by oxidative stress, today announced the appointment of Russell Kelley, Ph.D., MBA, to its board of directors.

Key Points: 
  • FORT WORTH, Texas, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Nacuity Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts, and other ocular diseases caused by oxidative stress, today announced the appointment of Russell Kelley, Ph.D., MBA, to its board of directors.
  • Dr. Kelley currently serves as managing director of the Retinal Degeneration (RD) Fund, the venture arm of Foundation Fighting Blindness and a significant investor of Nacuity.
  • Dr. Kelley is a pharmacologist who brings a wealth of experience advancing life science technologies to Nacuitys board.
  • Dr. Kelley helped launch the RD Fund and has been instrumental in building a portfolio of novel technologies including genetic medicines.

Foundation Launching its Largest Natural History Study to Date for 1,500 People with Inherited Retinal Diseases Caused by Rare Mutated Genes

Retrieved on: 
Thursday, November 10, 2022
IRDS, RPE65, Retina, Macular degeneration, Research, Gene, Population, Ophthalmology, Therapy, Nanoparticle, USH2A, Severe cognitive impairment, Company, CEP290, Genetics, University of Pittsburgh School of Medicine, Foundation Fighting Blindness, Wilfrid Sellars, USH1B, Environment, MYO7A, Doctor of Pharmacy, Triangle Park (Quezon City), CNGA3, AAV, Science, Patient, CEO, RHO, CNGB3, MD, RPGR, Doctor of Philosophy, Research Triangle, Foundation, HIV disease progression rates, Retinitis pigmentosa, CHM, Biotechnology, Retinal degeneration, Leber congenital amaurosis, PROM1, IRD, Technology, RDH12, Usher syndrome, PCDH15, University, Visual impairment, Atsena Otie Key, MBA, LCA, Natural history, Pharmaceutical industry, Medical device, Vaccine, Antibiotics, Opus, GUCY2D

COLUMBIA, Md., Nov. 10, 2022 /PRNewswire/ -- The Foundation Fighting Blindness, the world's leading organization committed to finding treatments and cures for blinding retinal diseases, is committing at least $8.6 million for its Uni-Rare Study, a new natural history study for approximately 1,500 people with one of more than 300 rare genes associated with inherited retinal diseases (IRDs) including: retinitis pigmentosa, Leber congenital amaurosis, Usher syndrome, and a broad range of other conditions.

Key Points: 
  • "A majority of the 300 genes linked to inherited retinal diseases have not been well characterized in the clinic.
  • "We are excited to launch a highly inclusive study to benefit a large segment of the population affected by IRDs, which are so genetically diverse."
  • Established in 1971, the Foundation Fighting Blindness is the world's leading private funding source for retinal degenerative disease research.
  • Opus Genetics is a groundbreaking gene therapy company for inherited retinal diseases with a unique model and purpose.