FDA重新考虑湿AMD疗法审查前景增强

2026-06-16 21:23

Outlook Therapeutics (OTLK) traded higher in the premarket on Tuesday after the U.S. Food and Drug Administration agreed to reconsider its marketing application for ONS-5010, a treatment targeting the eye disorder wet age-related macular degeneration (wet AMD).
The company shares crashed earlier this year after the FDA issued a complete response letter, declining to approve ONS-5010, which the regulator had already rejected in August.
Also known as Lytenava, ONS-5010 is an ophthalmic formulation of bevacizumab, a biologic therapy marketed by Roche (RHHBY) as Avastin.
Earlier this month, the New Jersey-based biotech said it has resubmitted a Biologics License Application for ONS-5010 for neovascular age-related macular degeneration (nAMD) or wet AMD. The FDA has issued a Class 1 review and a target action date of July 29, 2026, in connection with the BLA.

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