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Eyenovia Announces Poster Presentation at ARVO 2023

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Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company, announced a poster presentation at the ARVO 2023 meeting on April 25, showcasing their Optejet technology for delivering the anti-glaucoma medication latanoprost.

CEO Michael Rowe highlighted that the Optejet achieves therapeutic dosing with lesser exposure to harmful preservatives compared to conventional eye drops. The upcoming PDUFA date on May 8 for Mydcombi, a mydriasis agent, is crucial as it could validate the Optejet technology.

The study demonstrated Optejet via Micro-Array Print (MAP) reduces ocular surface stress and is associated with lower cell toxicity and inflammatory responses compared to traditional methods.

Positive
  • Eyenovia's Optejet technology achieves therapeutic doses with less exposure to harmful preservatives.
  • The upcoming May 8 PDUFA date for Mydcombi could validate the Optejet technology.
  • Study results indicate that Optejet reduces ocular surface stress and inflammatory responses.
Negative
  • None.

NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in connection with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced a poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2023 annual meeting, which is being held April 23-27 in New Orleans.

“This important study confirms that our proprietary Optejet dispensing technology can achieve a therapeutic dose of the anti-glaucoma medication latanoprost with significantly less exposure to excess drug and harmful preservatives than can be achieved using conventional eye drops,” stated Michael Rowe, chief executive officer of Eyenovia. “We are fast approaching the May 8th PDUFA date for our most advanced clinical program, the mydriasis agent Mydcombi, which, if approved, would be the first FDA approved product using the Optejet and would provide critical validation of this technology. We believe the Optejet can be leveraged across a broad range of high-value ophthalmic indications, many of which we plan to explore in the future through both internal development programs and external collaborations.”

Presentation details:

Title:Cytotoxicity Evaluation for BAK-Preserved Latanoprost Delivered by Drop Versus Micro-Array Print (MAP) Technology
  
Presenters:Pedram Hamrah, MD, and Deshea Harris, MSc, Tufts Medical Center, Boston
  
Date:April 25th, 2023
  
Time:11:45 a.m. – 1:30 p.m. CDT (12:45 p.m. – 2:30 p.m. EDT)
  
Location:Exhibit Hall
  
Posterboard #:B0374

Summary: Treatment with the anti-glaucoma medication Latanoprost that is preserved with benzalkonium chloride (BAK) over a long period of time has consistently demonstrated cytotoxic effects. This poster describes results of a study evaluating BAK-preserved latanoprost delivered via conventional eye dropper versus Eyenovia’s proprietary Micro-Array Print (MAP) technology.

This study found that Optejet using MAP technology has the potential to reduce ocular surface stress when administering BAK+ latanoprost. Excellent human conjunctival cell tolerability was observed and was comparable to preservative-free latanoprost. Significantly less cell toxicity, significantly lower RNA levels of proinflammatory chemokine IL-6 and CCL2, and significantly lower protein levels of proinflammatory cytokine IL-6 were observed.

Conclusion: MAP technology appears better in reducing inflammatory processes than BAK+ latanoprost administered with traditional eye drops. In conclusion, precision dosing has the potential to decrease ocular surface disorders typically associated with long-term use of preserved eye drops.

For more information: https://www.arvo.org/annual-meeting/

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAPTM) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information, visit Eyenovia.com.

The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.

Forward-Looking Statements

Except for historical information, all the statements, expectations and assumptions contained in this presentation 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 in some cases 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, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining 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; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical 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.

Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com

Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363

Eyenovia Media Contact:
Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com 


FAQ

What is the significance of the Eyenovia presentation at ARVO 2023?

The presentation highlights the efficacy of Eyenovia's Optejet technology in delivering latanoprost with reduced cytotoxicity compared to conventional methods.

When is the PDUFA date for Eyenovia's Mydcombi?

The PDUFA date for Eyenovia's Mydcombi is set for May 8, 2023.

What are the benefits of the Optejet technology?

Optejet technology is designed to deliver medications with less exposure to preservatives, potentially reducing ocular surface stress and inflammatory reactions.

How did Eyenovia's study compare Optejet to traditional eye drops?

The study found that Optejet using MAP technology has significantly lower cell toxicity and inflammatory markers compared to conventional eye drops.

Eyenovia, Inc.

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