
Eyenovia Announces First Patients Enrolled in Phase 3 Study of MicroLine for Presbyopia
News Release

Eyenovia Announces First Patients Enrolled in Phase 3 Study of MicroLine for Presbyopia
Topline Results Expected First Half of 2021
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 or “readers,” contact lenses or surgery.
“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,” said Dr.
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.
About MicroLine
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.
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Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the
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Eyenovia Contact:
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jgandolfo@eyenovia.com
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