Tag: retina

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

PARIS, July 07, 2025 (GLOBE NEWSWIRE) --  PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce that the first patient has been successfully dosed in its Phase I clinical trial (PST-611-CT1) aiming to assess safety and tolerability of its lead program, PST-611, in humans.

-  500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia

Dr. Clark Brings 25 Years of Experience Treating Retina Diseases and Developing Emerging Therapies as a Principal Investigator in Over 70 Clinical Trials and as an Early Pioneer of VEGF Inhibitors

- Broad Use of Suprachoroidal Injection Platform Highlighted Across Retinal Indications -

MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.