Primary endpoint was achieved with well-tolerated micro-array print (MAP™) safety profile
Upcoming key 12 month milestones include Mydcombi PDUFA; Vision 2 Phase 3 trial results and completion of enrollment for CHAPERONE Phase 3 trial
NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of MAP™ therapeutics, today announced that its VISION-1 study evaluating the company’s proprietary pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint. Preparations are underway for a second Phase 3 registration study, VISION-2. These studies are required for FDA approval and will serve as the basis for a planned New Drug Application (NDA) submission to FDA. VISION-1 results will be presented at a future ophthalmic-focused medical meeting.
The VISION-1 study evaluated the safety and efficacy of Eyenovia’s 1% and 2% pilocarpine Micro-Array Print formulations versus placebo, all administered via the company’s proprietary Optejet® dispenser. VISION-1 is the third Phase 3 study demonstrating the utility of the company’s MAP technology in improving the therapeutic index of topical ophthalmic drugs.