Eyenovia to Present at the Ophthalmology Innovation Summit (OIS) Presbyopia Innovation Showcase

Rhea-AI Summary

Eyenovia, Inc. (NASDAQ: EYEN), a clinical-stage ophthalmic biopharmaceutical company, announced that Dr. David Wirta will present at the Ophthalmology Innovation Summit Presbyopia Innovation Showcase on January 28th. His talk will address the challenges faced by presbyopia patients and discuss the advantages of using Eyenovia's pilocarpine via the novel Optejet® dispenser. Currently, Eyenovia is assessing its MicroLine formulation in two Phase 3 studies, VISION-1 and VISION-2, which began enrollment in December 2020. These innovations aim to improve the quality of life for the 113 million Americans affected by presbyopia.

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that Dr. David Wirta will speak at the Ophthalmology Innovation Summit Presbyopia Innovation Showcase on January 28^th.

Dr. Wirta’s presentation will outline the challenges that presbyopia patients face, and the potential benefits of administering pilocarpine through Eyenovia’s novel Optejet® dispenser. The company is currently evaluating its proprietary pilocarpine formulation in the Optejet dispenser (MicroLine¹) in two Phase 3 studies, VISION-1 and VISION-2. The VISION program commenced enrollment in December 2020.

Presbyopia is the age-related hardening of the eye’s lens, causing blurred near vision. It affects approximately 113 million Americans. Vision impairment typically begins after age 40 and is often corrected with eyeglasses or “readers,” contact lenses or surgery.

“We have known about the ability of pilocarpine to temporarily constrict the pupil and improve near vision for quite some time, yet the ability to administer a consistent dose, without the mess or side effect profile associated with traditional eyedroppers, has limited its use in this context,” stated Dr. Wirta, Medical Director, Eye Research Foundation, Newport Beach, Calif. “There are many surveys, as well as published studies, that conclude that wearing eyeglasses in this population may diminish quality of life and lead to certain biases, suggesting the need for an alternative solution. I believe Eyenovia’s MicroLine product, delivered by the Optejet dispenser, may be that solution.”

“We are grateful to Dr. Wirta for his continued support and leadership in the VISION studies of MicroLine for presbyopia,” stated Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. “We believe MicroLine has the potential to fundamentally change the way millions of Americans deal with presbyopia, and expect to have the data readout from our VISION 1 study by mid-year, subject to any impacts of COVID-19.”

Dr. Wirta is a consultant to Eyenovia. In addition to his current work on the VISION studies, he served as an investigator on Eyenovia’s Phase 3 MydCombi pharmacologic mydriasis studies. He was also a podium presenter of those studies at the 2019 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting. The company submitted its NDA for MydCombi to the FDA in December 2020.

Interested parties may register for the Showcase free of charge here.

¹ Eyenovia has out-licensed MicroLine to Arctic Vision (Hong Kong) Limited in Greater China and South Korea

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 1/5^th the drug volume of a traditional eye dropper, the Optejet is designed to deliver targeted, consistent doses more conveniently than typical eyedroppers.

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.

Forward-Looking Statements

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 U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the timing and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210126005382/en/

FAQ

What is Eyenovia's announcement regarding presbyopia?

Eyenovia announced Dr. David Wirta will speak at the Ophthalmology Innovation Summit on January 28th, focusing on presbyopia challenges and their Optejet dispenser.

When did the VISION studies for Eyenovia's MicroLine commence?

The VISION studies commenced enrollment in December 2020.

How many Americans are affected by presbyopia according to Eyenovia's press release?

Approximately 113 million Americans are affected by presbyopia.

What are the Phase 3 studies mentioned in Eyenovia's announcement?

Eyenovia is currently conducting two Phase 3 studies called VISION-1 and VISION-2 for their MicroLine product.

What is the expected outcome date for Eyenovia's VISION-1 study?

Data from the VISION-1 study is expected to be available by mid-year, subject to any impacts from COVID-19.