FDA Approves Eyenovia’s IND Application for MicroLine for Presbyopia, Allowing for Phase 3 Trials
Eyenovia announced that the FDA has accepted its investigational new drug (IND) application for MicroLine, a proprietary pilocarpine formulation for the improvement in near vision in patients with presbyopia. The company intends to initiate the phase 3 VISION program, beginning with the VISION-1 study later this month.
MicroLine is Eyenovia’s proprietary presbyopia formulation of pilocarpine. Pilocarpine is a well-characterized drug in ophthalmology, with many studies demonstrating its ability to increase the eye’s depth of focus to counter the age-related loss of accommodative effect and improve near vision. The use of pilocarpine for presbyopia as an eye drop may be limited due to the potential for dose-related side effects as well as the inconvenience and inconsistency of dosing with traditional eye droppers. Eyenovia’s MicroLine is a proprietary microdosed formulation of pilocarpine that is delivered via the company’s Optejet dispenser. High precision microdosing at approximately 1/5th the drug volume of a traditional eye dropper with the Optejet is designed to deliver targeted, consistent doses more conveniently than typical eyedroppers.
“We prioritized the development of MicroLine because of the significant unmet need we see in presbyopia, and because we believe MicroLine can address many shortcomings of current treatment options by delivering a microdose of pilocarpine via our proprietary Optejet dispenser,” Dr. Sean Ianchulev, MD, PhD, Chief Executive officer and Chief Medical Officer of Eyenovia, said in a company news release. “We are on track to initiate the VISION-1 phase 3 trial by year end, subject to any impacts of COVID-19. We believe the VISION studies could confirm that our approach to presbyopia is a well-tolerated, effective, on-demand complement to reading glasses for those situations when wearing glasses is less than ideal.”
The VISION trials are phase 3, doubled-masked, placebo-controlled, cross-over superiority trials that will enroll participants between the ages of 40 and 60 with presbyopia. The primary endpoint is binocular distance corrected near visual acuity. MicroLine is intended for the “on demand” symptomatic treatment of near vision impairment secondary to presbyopia.