Positive topline results from VISION-1 phase III study of Microline for the treatment of presbyopia.-Eyenovia

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 III study demonstrating the utility of the company’s MAP technology in improving the therapeutic index of topical ophthalmic drugs. Key highlights from the study include : VISION-1 met its primary endpoint with a statistically significant proportion of subjects treated with a therapeutic dose of MicroLine showing a three-line or more improvement in distance corrected near visual acuity (DCNVA) versus placebo in low light conditions at two hours post-treatment. MicroLine was very well tolerated. Adverse events were all mild in nature and there were no serious adverse events. In a post-study survey, 70% of study participants reported strong interest in using MicroLine for near vision improvement should it be approved. These patients said they would expect to use the product three to four times per week on average.