Ocugen plans FDA filings for three eye-disease gene therapies in 2027 and 2028
Image: Primary Ocugen outlined plans to seek U.S. approval for three experimental gene therapies for serious eye diseases. It expects trial results for OCU400, which targets retinitis pigmentosa, in the first quarter of 2027 and for OCU410ST, which targets Stargardt disease, in the second quarter. The company plans to file applications after those results.
A third treatment, OCU410 for geographic atrophy associated with dry age-related macular degeneration, is scheduled for an application at the end of 2028. An independent monitoring committee reviewed the ongoing OCU410ST study, which will continue as planned. The applications depend on trial results and do not establish that any treatment will receive approval.
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