Eyenovia Announces Publication of Study Demonstrating Favorable Impact on the Ocular Surface of Medication Delivered with the Optejet®

Rhea-AI Summary

Eyenovia (NASDAQ: EYEN) announced two significant developments for its Optejet® dispenser. A study published in the Journal of Ocular Pharmacology and Therapeutics demonstrated that Optejet can deliver latanoprost with significantly less exposure to harmful preservatives compared to traditional eye drops, avoiding cytotoxicity associated with larger volumes. Additionally, a Phase 4 study of Mydcombi, presented at the American Academy of Optometry, showed that a half-dose achieved clinically relevant pupil dilation with favorable safety outcomes. The study reported mean pupil diameter changes from 2.74mm at baseline to 6.42mm after 30 minutes, with 67% of eyes dilated to ≥6mm.

Positive

• Optejet demonstrates ability to deliver medication with 80% less volume than traditional eye drops
• Study shows reduced exposure to harmful preservatives while maintaining therapeutic efficacy
• Phase 4 study confirms effectiveness of half-dose administration, potentially expanding product applications
• Favorable safety profile with only mild adverse events reported in clinical study

Negative

• None.

Insights

Medical Research Analyst

The publication of this study represents a significant scientific advancement for Eyenovia's Optejet technology. The research demonstrates two key findings: 80% reduction in preservative exposure while maintaining therapeutic efficacy and successful pupil dilation with half-dose administration.

The preservative reduction finding is particularly important as BAK-related ocular surface toxicity is a major concern in ophthalmology. The ability to achieve therapeutic effects with reduced preservative exposure could lead to better treatment adherence and fewer side effects. This opens opportunities for reformulating existing medications using Optejet technology.

The Phase 4 study results showing effective pupil dilation with half-doses (67% of eyes reaching ≥6mm dilation) and faster recovery time provides clinical validation for dose optimization. This flexibility in dosing could be particularly valuable for specific patient populations requiring shorter duration procedures.

Publication in the Journal of Ocular Pharmacology and Therapeutics highlights the ability of the Optejet to achieve a therapeutic dose of medication with far less exposure to harmful preservatives

Additional presentation at the American Academy of Optometry summarizes a Phase 4 study of Mydcombi demonstrating that clinically relevant mydriasis can be achieved with a half-dose per eye

NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a publication in the Journal of Ocular Pharmacology and Therapeutics as well as an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis” Annual Meeting.

Publication in the Journal of Ocular Pharmacology and Therapeutics

The peer-reviewed paper highlights the ability of Eyenovia’s proprietary Optejet dispenser to deliver a therapeutic dose of latanoprost with far less exposure to the preservative benzalkonium chloride (BAK) than traditional eye drops. BAK, in larger volumes, can cause unwanted side effects, including cytotoxicity, cytoplasmic shrinkage, and loss of cell-cell contact, and expression of chemokine (C-C motif) ligand 2 and interleukin-6 (markers of inflammation).

In contrast, this in-vitro study of latanoprost plus BAK delivered in the same amount by the Optejet dispenser (8 microliters) avoided the cytotoxicity associated with larger volumes found in eye drops and was similar to no treatment controls and BAK-free latanoprost drops.  

“We have shown in prior studies the ability of the Optejet dispenser to achieve a therapeutic dose of medication with approximately 80% less volume and exposure to harmful preservatives than traditional eye drops,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The implication here is that preserved medications may not need to be reformulated to get many of the benefits of non-preserved products if delivered with the Optejet. We believe this creates potential opportunities for the Optejet to improve the administration of topical ocular therapeutics well beyond our own development pipeline.”

Presentation at the American Academy of Optometry’s “Academy 2024”

Eyenovia also announced today an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis,” which is being held November 6-9, in Indianapolis, IN.

The presentation details the results of an open-label Phase 4 study of 1% tropicamide and 2.5% phenylephrine ophthalmic metered spray, similar to Mydcombi, Eyenovia’s commercially available product for inducing mydriasis.

Twenty-nine subjects completed the study and administered one spray. Baseline pupil diameter (PD) for all eyes was 2.74±0.48 mm. Mean change in PD from baseline to 30 minutes was 3.69±1.25 mm. At 30 minutes post-dosing, mean PD was 6.42±1.25 mm, with 67% and 43% of eyes dilated to ≥ 6mm and 7mm, respectively. The majority of patients returned to functional vision (PD ≤ 5 mm) as early as 3.5 hours post-instillation, with 93% reaching that point by six hours. Safety outcomes were favorable, as only mild adverse events were reported (dry eye and mild instillation site pain) all of which resolved without intervention.

“We conducted this study to address questions from doctors about modulating dosing for patients who may benefit from a lower dose of tropicamide or phenylephrine,” stated Dr. Julie Whitcomb, Senior Director of Medical Affairs at Eyenovia. “What we found in this study was that a half dose may also provide clinically relevant pupil dilation, was well-tolerated, and had a desirable shorter duration of effect.”

Presentation details:

Title:	An Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Tropicamide 1% and Phenylephrine 2.5% Ophthalmic Spray (MydCombi®)
Poster:	#109, Exhibit Hall H
Presenter:	Dr. Josianne Manasse, OD, SUNY College of Optometry
Date/time:	Friday, November 8th, 1:00-3:00pm

For additional information on the Expo: https://aaopt.org/meetings/academy-2024-indianapolis/

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi^® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-surgical pain and inflammation, as well as the ongoing late-stage development of medications in the Optejet device for pediatric progressive myopia as well as out-licensing for additional indications. For more information, visit Eyenovia.com.

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

PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05%

Forward-Looking Statements
Except for historical information, all 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 the timing and scale of acceptance and use of our approved products. 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 products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and 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 product candidates; 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. Andy Jones Chief Financial Officer ajones@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 key findings of Eyenovia's (EYEN) Optejet study published in 2024?

The study showed Optejet can deliver latanoprost with significantly less exposure to BAK preservative than traditional eye drops, avoiding cytotoxicity while maintaining therapeutic effectiveness.

What were the pupil dilation results in Eyenovia's (EYEN) Phase 4 Mydcombi study?

The study showed mean pupil diameter increased from 2.74mm to 6.42mm after 30 minutes, with 67% of eyes dilated to ≥6mm and 43% to ≥7mm using a half-dose.

How long did pupil dilation effects last in Eyenovia's (EYEN) Mydcombi Phase 4 study?

The majority of patients returned to functional vision (pupil diameter ≤5mm) as early as 3.5 hours post-instillation, with 93% reaching that point by six hours.