Eyenovia Announces FDA Acceptance of IND for MicroLine for Presbyopia, Clearing Path to Initiate Phase 3 VISION Trial by Year End
Eyenovia, Inc. (NASDAQ: EYEN) announced that the U.S. FDA has accepted its IND application for MicroLine, a pilocarpine formulation aimed at enhancing near vision in presbyopia patients. The company plans to initiate the Phase 3 VISION program, starting with the VISION-1 study later this month. Presbyopia affects around 113 million Americans, with MicroLine offering a microdosed alternative to traditional eye drops using the Optejet® dispenser for precise dosing. The VISION trials will focus on assessing the effectiveness of MicroLine in adults aged 40-60 with presbyopia.
- FDA acceptance of IND application for MicroLine.
- Planned initiation of Phase 3 VISION program with VISION-1 study by year-end.
- MicroLine offers a new microdosed delivery system via Optejet, addressing current treatment limitations.
- Risks associated with clinical trial design and enrollment may be impacted by COVID-19.
- Dependence on timely regulatory approvals for product candidates.
NEW YORK--(BUSINESS WIRE)--Eyenovia, Inc., (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U. S. Food and Drug Administration (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.
Presbyopia, the age-related hardening of the lens causing blurred near vision, affects approximately 113 million Americans. Vision impairment typically begins after age 40 and is often corrected with eyeglasses, contact lenses or surgery. Because many individuals with presbyopia have otherwise normal vision, presbyopia has been shown to have a negative impact on quality of life and wearing glasses is often the first outward sign of aging.
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,” said Dr. Sean Ianchulev, Chief Executive officer and Chief Medical Officer of Eyenovia. “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.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.
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