Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting

Rhea-AI Summary

Eyenovia, Inc. (NASDAQ: EYEN) announced upcoming presentations on their clinical trials at the American Academy of Optometry Academy 2020 event. Dr. April Jasper will present updates on the CHAPERONE and VISION studies, focusing on low-dose atropine and pilocarpine for myopia and near vision improvement, respectively. Dr. Siddarth Rathi will discuss results from the MIST studies, evaluating a microdose formulation for pupil dilation. Eyenovia's innovative microdose array print (MAP™) therapeutics aim to enhance treatment efficacy for various ophthalmic conditions.

Positive

• Upcoming presentations at the American Academy of Optometry highlight significant clinical trial updates.
• The CHAPERONE study may offer effective solutions for pediatric myopia progression.
• The VISION study focuses on improving near vision, addressing a widespread issue.
• Eyenovia's proprietary MAP™ technology is on track for future NDA filings, expanding its market potential.

Negative

• None.

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 Drs. Siddarth Rathi and April Jasper will present the latest analyses and updates from the company’s clinical studies at the American Academy of Optometry Academy 2020 At Home Con.

On Wednesday, October 7, April Jasper, OD, medical monitor for the company’s CHAPERONE study and member of the Eyenovia Scientific Advisory Board, will provide pre-recorded updates on the CHAPERONE (evaluation of low-dose atropine for the reduction of pediatric myopia progression) and the VISION (evaluation of low-dose pilocarpine for improvement in near vision) clinical trials. Dr. Jasper will also provide an update on the company’s upcoming Mydcombi (low-dose tropicamide and phenylephrine fixed combination for pupil dilation) NDA filing with the U.S. Food and Drug Administration (FDA).

On Thursday, October 8 at 6 p.m. EDT, Siddarth Rathi, MD, of The Eye Institute of West Florida and medical monitor for the MIST 1 and MIST 2 studies, will present additional analyses of data from the MIST 1 and MIST 2 studies of Eyenovia’s proprietary first-in-class fixed combination microdose formulation of phenylephrine and tropicamide for mydriasis (pupil dilation). Clinical results will cover Pupil Dilation Speed with MAP™ Fixed Combination (FC) Tropicamide 1% Phenylephrine 2.5% (TR-PH)-Ophthalmic Solution.

About Eyenovia

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, please visit www.eyenovia.com.

About MicroPine for Progressive Myopia

MicroPine (atropine ophthalmic solution) is being evaluated in the CHAPERONE Phase 3 clinical study for reduction in pediatric myopia progression. Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, myopic maculopathy, retinal detachment, posterior subcapsular cataract, glaucoma and visual impairment. MicroPine has been developed for comfort, hygiene and ease-of-use in children. Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).

Feasibility Dose-finding Atropine Studies: ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials)

About MicroLine for Presbyopia

MicroLine (pilocarpine ophthalmic solution) is a pharmacologic treatment for presbyopia which will be evaluated in the VISION 1 and VISION 2 Phase 3 clinical studies. Presbyopia is the non-preventable, age-related hardening of the natural lens, which causes a gradual loss of the eye’s ability to accommodate or focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options are typically device-based, such as reading glasses, progressive and multifocal contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the company’s high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability and usability.

About Mydcombi™ for Mydriasis

Mydcombi is Eyenovia's first-in-class fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive and diabetic eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed for use without anesthetic, we are developing Mydcombi to improve the efficacy and tolerability of pharmacologic mydriasis.

About Optejet® and MicroRx Ocular Therapeutics

Eyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet is less than 75% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40% – 50% with conventional eyedroppers. The design of Optejet includes no protruding nozzle to help reduce the risks of dispenser to eye contact and contamination reported with conventional droppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.