Positive results from VISIO-2 phase III trial of Microline as a potential on demand treatment for presbyopia

The VISION-2 study evaluated the safety and efficacy of Eyenovia’s 2% pilocarpine micro-array print (MAP) formulation versus placebo, all administered via the company’s proprietary Optejet device. VISION-2 is the fourth 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; i. In a modified per-protocol analysis of evaluable patients, excluding a non-study related adverse event impacting pupil size and reactivity (new onset anisocoria), VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment. ii. The study also achieved all secondary endpoints at a statistically significant level. iii. MicroLine was very well tolerated. Adverse events were reported in fewer than 3% of patients, and all were mild and/or transient.

Michael Rowe, Chief Executive Officer of Eyenovia stated- “Proprietary market research that we conducted in May of this year reveals that 80% of patients in our target market surveyed would prefer the Optejet device over traditional eyedrops. That market consists of presbyopes between the ages of 40 and 55 years who have otherwise never needed to wear glasses. We view Optejet as a significant advantage not only for MicroLine, but for our entire pipeline of development programs, including MydCombi for pharmacologic mydriasis, for which we are preparing to resubmit our New Drug Application (NDA), and MicroPine for progressive myopia,”

“The positive results from this study confirm earlier findings that MicroLine may represent an exciting new on-demand treatment option for the millions of people who suffer from presbyopia who never had to wear reading glasses previously,” stated April Jasper, OD, medical monitor and scientific advisor to the company. “Of note in this study is the very low incidence of side effects, such as headache and brow ache, that are often associated with topical pilocarpine treatments. This is due to the precision dispensing of the Optejet, which coats the corneal surface without exposing the eye to excess drug and preservative toxicity. I look forward to incorporating this novel technology into my own practice if and when approved.”

The VISION-2 study was a double-masked, placebo-controlled, cross-over superiority trial in which 140 subjects with presbyopia were treated. During the study, subjects were randomly assigned to a treatment sequence for dosing with pilocarpine 2% as well as placebo, both administered via the Optejet dispenser. The primary endpoint was improvement in high contrast binocular distance corrected near visual acuity without loss of distance vision measured in low light conditions 2 hours after treatment.