Eyenovia Announces First Patients Enrolled in Phase 3 Study of MicroLine for Presbyopia
Eyenovia announced that the first set of patients has been enrolled in the company’s phase 3 VISION-1 study of MicroLine, its proprietary pilocarpine formulation delivered via its Optejet dispenser, for the improvement in near vision in patients with presbyopia.
“Eyenovia’s VISION studies are designed to demonstrate improvement in near visual acuity in patients with presbyopia. Along with mydriasis and myopia, this is our third phase 3 program using our smart 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 microdosing,” Sean Ianchulev, MD, PhD, Chief Executive Officer and Chief Medical Officer of Eyenovia, said in a company news release. “With our first set of patients now enrolled in the phase 3 VISION-1 study, we expect to complete enrollment 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. MicroLine is designed for use “on demand” for symptomatic improvement of near vision impairment secondary to presbyopia.
“For the large percentage of my patients who have no prior vision impairment, developing presbyopia can be a life-altering event as they come to terms with one of the first outward signs of aging,” said Dr. David Wirta of the Eye Research Foundation in Newport Beach, California, a VISION-1 study investigator. “MicroLine has the potential to remove my patients’ dependance on reading glasses by providing an easy-to-use pharmaceutical treatment that could add to our options in treating this condition.”
Dr. William Flynn, Director of Eye Associates Research Center of San Antonio, Texas and a VISION-1 study investigator, added, “Many patients find transitioning from no glasses to reading glasses has a significant impact on their quality of life. By providing a way to minimize this impact so that glasses are not needed in all situations, we have the potential to help improve our patients’ treatment satisfaction.”
Eyenovia’s MicroLine is a proprietary microdosed formulation of pilocarpine for presbyopia that is delivered via the company’s Optejet dispenser. Providing high precision microdosing at approximately 1/5th the drug volume of a traditional eyedropper, the Optejet is designed to deliver targeted, consistent doses more conveniently than typical eyedroppers.