Ocular Therapeutix Plans to File Eye Disease Drug Marketing Application in Q4
MT Newswires Live
Sep 15
Ocular Therapeutix (OCUL) said Tuesday that its marketing application for Axpaxli, its experimental treatment for wet age-related macular degeneration, remains on track for submission in Q4 following its meeting with the US Food and Drug Administration.
The company said the FDA meeting confirmed the planned marketing application package, which will include efficacy and safety data from a phase 3 trial, interim safety data from an ongoing trial, and other supporting evidence.
The application will be submitted under a pathway that could shorten the FDA review timeline by up to 60 days compared with the traditional submission, it added.
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