Benzinga | May 25, 2021 09:05AM EDT

Eyenovia Reports Topline Results From VISION-1 Phase 3 Study Of MicroLine For Treatment Of Presbyopia Met Primary Endpoint

Primary endpoint was achieved with well-tolerated micro-array print (MAP(tm)) 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(tm) 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(r) 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.

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.

"We are extremely pleased at the success of our VISION-1 study, marking another major milestone for our Micro-Array Print platform technology," stated Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "Along with plans for VISION-2 in the coming months, we continue to prepare for the potential FDA approval of MydCombi(tm) for mydriasis in the fourth quarter and full enrollment of the CHAPERONE study for pediatric myopia shortly thereafter."

Presbyopia is the age-related, progressive hardening of the eye's lens, making it difficult for the clear lens of the eye to change shape. Presbyopia causes blurred near vision and is often corrected with eyeglasses or "readers," contact lenses or surgery. In the 40 to 55 age group, approximately 18 million people in the U.S. are presbyopic, suggesting a multi-billion U.S. market opportunity for MicroLine, if approved.

Dr. Robert Weinreb, Distinguished Professor and Chair of Ophthalmology at the University of California, San Diego, added, "Besides being a new option for presbyopic patients, MicroLine also may improve community eye health. Presbyopic patients now often obtain reading glasses without a comprehensive eye examination. With the potential future availability of MicroLine, such patients instead might seek an eye examination in order to obtain a prescription for the product."

"Optometrists know that presbyopic patients are seeking more options to help them perform common activities, such as reading a menu or glancing at their smart phone," said April Jasper, OD FAAO and Eyenovia Medical Monitor. "Many of these patients simply purchase reading glasses without the benefit of a regular eye exam and end up unhappy being dependent on them and because they can make them look older. The ability to have an option such as MicroLine could address a common request from patients for the freedom to not have to wear glasses in certain situations."