Eyenovia (NASDAQ:EYEN) announced that the first set of patients has been enrolled in the company’s Phase 3 VISION-1 study of MicroLine, a proprietary pilocarpine formulation delivered via its Optejet dispenser for the improvement in near vision in patients with presbyopia.
Presbyopia is an age-related hardening of the lens causing blurred near vision, which affects approximately 113 million people in the U.S. Vision impairment typically begins after age 40 and is often corrected with eyeglasses or readers, contact lenses or surgery.
Along with mydriasis and myopia, this is Eyenovia’s third Phase 3 program using its Optejet system, which is the “first technology of which we are aware to demonstrate the benefits in Phase 3 trials of topical ophthalmic therapies using high precision, targeted micro-dosing,” Dr. Sean Ianchulev, CEO and CMO of Eyenovia, said in a statement.
The company expects to complete enrollment in the VISION-1 study relatively quickly and have topline data in the first half of 2021, subject to any impacts of COVID-19.
The VISION trials are Phase 3, double-masked, placebo-controlled, cross-over superiority trials that will each enroll approximately 100 participants between the ages of 40 and 60 who suffer with visual impairment from presbyopia. The primary endpoint is same-day improvement of binocular distance corrected near visual acuity.