The company plans to start a second Phase 3 registration study, VISION-2, as it continues on path toward a New Drug Application submission to the FDA.
Eyenovia Inc. on Tuesday announced that the company’s VISION-1 study evaluating the company’s pilocarpine formulation, MicroLine, for the temporary improvement of near vision in adults with presbyopia, achieved its primary endpoint.
According to the company, 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 the FDA.
The company noted that VISION-1 results will be presented at an upcoming 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 a 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.
According to the company, 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.
Moreover, investigators also found that MicroLine was well tolerated. Adverse events were all mild in nature and there were no serious adverse events.
A post-study survey found that 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.
Sean Ianchulev, MD, CEO and chief medical officer of Eyenovia, pointed out that the company was pleased with the VISION-1 study results, which he said “marks another major milestone for our Micro-Array Print platform technology.”
“Along with plans for VISION-2 in the coming months, we continue to prepare for the potential FDA approval of MydCombi for mydriasis in the fourth quarter and full enrollment of the CHAPERONE study for pediatric myopia shortly thereafter,” he said in a statement.
Robert Weinreb, MD, distinguished professor and chairman of Ophthalmology at the University of California, San Diego, noted in a statement that MicroLine also may improve community eye health.
“Presbyopic patients now often obtain reading glasses without a comprehensive eye examination,” he said in the statement. “With the potential future availability of MicroLine, such patients instead might seek an eye examination in order to obtain a prescription for the product.”
The VISION trials are Phase 3, double-masked, placebo-controlled, cross-over superiority trials that will enroll participants with presbyopia. The primary endpoint is binocular distance corrected near visual acuity. MicroLine is intended for the “on demand” improvement of near vision in people with presbyopia.