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Ocugen launches Phase III trial of one-time gene therapy for geographic atrophy
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Fusion42 · 1 September 2026 · Fusion42 review
Ocugen has initiated a global Phase III trial of OCU410, a one-time gene therapy for geographic atrophy secondary to dry age-related macular degeneration. The trial follows FDA alignment on endpoints and design, targeting a Biologics License Application in 2028, with potential for regulatory filings in the US and Europe.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it.
◆ ◆ The Wire takeaway
The FDA’s acceptance of a single pivotal Phase III gene therapy trial opens a streamlined path for durable one-time treatments in ophthalmology. You should track how this shift affects development timelines and regulatory expectations for gene therapies targeting chronic conditions.
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2 sources · 1 Sep 2026
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