Eyenovia Announces Positive Study Results Demonstrating that its Optejet® Delivery Technology Reduces Conjunctival Cell Toxicity from Preserved Ophthalmic Solutions to a Level Comparable with Non-Preserved Solutions

Rhea-AI Summary

Eyenovia, Inc. (NASDAQ: EYEN) announced positive results from a study with Tufts Medical Center evaluating its Optejet microdose technology against standard eye drops using Latanoprost + Benzalkonium Chloride (BAK). The study demonstrated that Optejet significantly reduced ocular surface damage compared to traditional methods. This new approach minimizes the toxic effects associated with preservatives found in standard treatments, which is a major concern for patients using long-term ocular therapies for conditions like glaucoma. The findings support the efficacy of Eyenovia's innovative MAP™ therapeutics.

Positive

• Successful study results showing Optejet technology reduces ocular surface damage.
• Study indicates improved tolerance of Latanoprost + BAK when using Optejet compared to standard drops.
• Aligns with Eyenovia's focus on addressing long-term ocular adverse effects from preservatives.

Negative

• None.

Study conducted with Tufts Medical Center represents a breakthrough showing that Microdose Array Print (MAP™) technology can provide similar benefits of non-preserved medications

NEW YORK, March 15, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, today announced positive results from a research study conducted in collaboration with Dr. Pedram Hamrah, Interim Chairman of Ophthalmology at Tufts Medical Center, which evaluated the ocular surface damage from Latanoprost+Benzalkonium Chloride (BAK) treatment administered via Optejet versus Latanoprost+BAK administered via standard eye drops.

Preservatives in topical ophthalmic drugs administered via standard eye drops help ensure sterility of the product and increase shelf-life. However, patients on chronic topical ophthalmic drug treatments often display long term ocular adverse effects due to toxicity from over-exposure to preservatives.  

“Long term use of ophthalmic eye drops with preservatives is a significant clinical concern and therapeutic burden,” remarked Professor Robert Weinreb, MD, Chair of Ophthalmology at the University of California, San Diego and member of the Eyenovia Scientific Advisory Board. “For patients with chronic conditions such as glaucoma, this is a major concern when treatment with topical medications can last a lifetime.”

Per the study design, conjunctival epithelial cells were exposed to drug by standard drop or Optejet microdose technology. Cell-based assays were then conducted to assess cell viability, cytotoxicity, apoptosis, ROS generation and ATP generation (metabolic activity).

The study found that human conjunctival epithelial cells tolerated Latanoprost+BAK treatment administered via Optejet technology significantly better than Latanoprost+BAK administered via standard drops. Optejet technology had similar results to both latanoprost without BAK and no-treatment controls with respect to all four measures.

Beth Scott, OD, Vice President of Regulatory and Medical Affairs at Eyenovia, commented, “It is well established that BAK preservative in most preserved eye drops causes damage to the ocular surface, including the cornea epithelium, conjunctiva, and neural cells. The current study successfully proved that due to the much smaller volume of drug and preservatives required with the Optejet device, the level of ocular surface damage due to preservative toxicity would be minimal. This study adds to the body of evidence supporting our breakthrough Optejet technology.”

About Eyenovia, Inc. 
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP^TM) 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 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 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 (which could still be adversely impacted by COVID-19 and resulting social distancing), 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 impacts of COVID-19 on our supply chain; 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 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.

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 were the results of the Eyenovia study conducted with Tufts Medical Center?

The study found that Eyenovia's Optejet technology significantly reduces ocular surface damage compared to standard eye drops with Latanoprost + BAK.

How does Optejet technology benefit patients using eye drops?

Optejet minimizes the toxic effects associated with preservatives in traditional eye drops, improving patient tolerance and safety.

When was the study by Eyenovia and Tufts Medical Center announced?

The study results were announced on March 15, 2022.

What is the relationship between Eyenovia and Tufts Medical Center?

Eyenovia collaborated with Tufts Medical Center for a study evaluating the efficacy of its Optejet technology.

What is Eyenovia's focus in the ophthalmic market?

Eyenovia is focused on developing microdose therapies for conditions like mydriasis, presbyopia, and myopia progression.