Ocugen (OCGN) said Monday that the European Medicines Agency's Committee for Advanced Therapies issued a positive opinion granting Advanced Therapy Medicinal Product classification for its OCU410 and OCU410ST gene therapy candidates, which are being developed to treat vision loss caused by geographic atrophy and Stargardt disease.
Dosing in the Phase 2 portion of the OCU410 clinical trial has been completed, and Ocugen expects to begin a Phase 3 trial next year, with plans to pursue regulatory approval in the US and Europe in 2028.
Last week, the US Food and Drug Administration endorsed Ocugen's plan to initiate a Phase 2/3 pivotal confirmatory trial for OCU410ST, which could support future biologics license and marketing authorization applications in the US and EU, respectively.
If approved, OCU410 could become the first treatment available in Europe for geographic atrophy, a late-stage form of dry age-related macular degeneration. While two therapies are currently approved in the US, neither has received approval in the EU.
Ocugen is also developing OCU410ST for Stargardt disease, a genetic eye disorder that causes progressive vision loss. There are no approved treatments available for Stargardt disease globally, according to the company.
Shares of Ocugen were down over 2% in recent trading.
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