MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has reached a significant milestone in the development of a groundbreaking treatment for geographic atrophy (GA), an advanced form of dry age-related macular degeneration (dAMD) that affects approximately 1 million Americans. The biopharmaceutical company announced the completion of dosing in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA), a novel modifier gene therapy candidate.
OCU410 is being developed as a unique, one-time, gene-agnostic treatment designed to regulate multiple disease pathways—including lipid metabolism, inflammation, oxidative stress, and the membrane attack complex (complement)—with just a single sub-retinal injection. This innovative approach stands in contrast to existing FDA-approved anti-complement therapies for GA, which target only a single pathway and require multiple intravitreal injections over several years.
The recent dosing phase involved three subjects receiving a medium dose of OCU410 through subretinal administration. This step marks a pivotal advancement in the ArMaDa clinical trial, conducted across up to 13 leading retinal surgery centers in the United States.
Dr. Huma Qamar, Chief Medical Officer of Ocugen, expressed optimism about OCU410’s potential to offer a transformative solution for GA treatment. Similarly, Syed M. Shah, MD, the lead investigator for the OCU410 trial, highlighted the therapy’s promise to change the therapeutic landscape for GA, offering a significant improvement over the limited benefits of current treatments.
The ArMaDa trial’s next phase involves a Data and Safety Monitoring Board meeting to review the 4-week safety data of the medium dose cohort before proceeding to the high dose—the final step in the Phase 1 dose-escalation study. This comprehensive trial aims to evaluate the safety of unilateral subretinal administration of OCU410 in subjects with GA, encompassing both dose-ranging and dose-expansion studies.
As Ocugen continues to pioneer this potentially life-altering therapy, the GA community watches closely, hopeful for a simpler and more effective treatment option. With ongoing updates from the company, the medical community and patients alike are eager to see how OCU410 could redefine the management of age-related macular degeneration.
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