Benzinga | Nov 4, 2021 08:19AM EDT

Eyenovia Reports First Patient Enrolled In Phase 3 VISION-2 Trial Of MicroLine For Presbyopia

Vision-2 follows successful Vision-1 trial with expected top-line results in Q2 2022

Presbyopia represents a multi-billion-dollar market opportunity in the U.S. alone

NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP(tm)) therapeutics, today announced that the first patient has been enrolled in the Company's second Phase 3 clinical trial of MicroLine, its proprietary pilocarpine formulation for temporary improvement in near vision (presbyopia), known as VISION-2.

"Following the completion of VISION-1 study, we are pleased to initiate this second Phase 3 trial that, if successful, will contribute to the clinical evidence supporting a new drug/device combination application to the US FDA," stated Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "By leveraging the numerous benefits of our microdose array print (MAP(tm)) technology, we believe MicroLine has the potential to be among the first drug treatments to improve blurred near vision that can adversely impact quality of life in patients with presbyopia."

"Additionally, with 18 million people between the ages of 40 and 55 in the US afflicted with presbyopia, this is a significant market opportunity for our company -- in excess of several billion dollars according to very recent third-party market research. We look forward to continuing to advance this promising and differentiated therapeutic through late-stage development for the potential benefit of patients, eye care practitioners and shareholders alike."

The VISION-2 study is a double-masked, placebo-controlled, cross-over superiority trial in which approximately 140 subjects with presbyopia will be treated. During the study, subjects will be randomly assigned to a treatment sequence for dosing with pilocarpine 2% as well as placebo, both administered via the Optejet(tm) dispenser. The primary endpoint is improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions 2 hours after treatment. Topline data is expected in mid-2022.