Eyenovia & SGN Nanopharma Announce Collaboration Agreement to Develop Novel Treatment for Chronic Dry Eye Disease

Rhea-AI Summary

Eyenovia (NASDAQ: EYEN) and SGN Nanopharma have announced a collaboration agreement to develop a novel treatment for chronic dry eye disease. The partnership aims to combine SGN's Micellar Nanoparticle Platform (MNP) cyclosporine formulation with Eyenovia's Optejet® dispenser. This collaboration targets the $3 billion U.S. addressable market for dry eye disease, affecting an estimated 35 million people.

Key points:

• SGN's MNP Cyclosporine showed superior results in clinical studies compared to current treatments
• Optejet dispenser delivers medication with 80% less drug volume, potentially improving tolerability
• The companies aim to create a 'best-in-class' therapy for the underserved dry eye market
• They plan to validate manufacturability and consult with the FDA for clinical development

Positive

• Collaboration targets a $3 billion U.S. addressable market for dry eye disease
• SGN's MNP Cyclosporine showed statistical superiority in clinical studies versus current standard of care
• Optejet dispenser delivers medication with 80% less drug volume, potentially improving tolerability
• Potential to create a 'best-in-class' therapy for the underserved dry eye market

Negative

• None.

Pharmaceutical Industry Analyst

This collaboration between Eyenovia and SGN Nanopharma marks a significant development in the dry eye disease treatment landscape. The partnership aims to combine SGN's Micellar Nanoparticle Platform (MNP) cyclosporine formulation with Eyenovia's Optejet® dispenser, potentially addressing key shortcomings in current treatments.

The $3 billion U.S. addressable market for dry eye disease presents a substantial opportunity. With $2.35 billion derived from cyclosporine-based therapeutics, there's clear demand for improved solutions. The companies' approach could disrupt this market by offering:

• Faster onset of action (4 weeks vs. up to 12 weeks for current treatments)
• Reduced side effects, particularly corneal irritation
• 80% less drug volume, minimizing exposure to preservatives

If successful, this combination therapy could indeed become the new standard of care, potentially capturing a significant market share. However, investors should note that the product is still in early stages, with manufacturability validation and FDA consultations pending. The path to market approval and commercialization will require substantial time and resources.

Overall, this collaboration represents a promising opportunity with substantial market potential, but it's important to temper expectations with the realities of pharmaceutical development timelines and regulatory hurdles.

Ophthalmology Specialist

The collaboration between Eyenovia and SGN Nanopharma represents a potentially groundbreaking advancement in dry eye disease treatment. As an ophthalmologist, I'm particularly intrigued by the combination of SGN's MNP cyclosporine formulation and Eyenovia's Optejet® dispenser.

Current cyclosporine treatments, while effective, have significant drawbacks:

• Delayed onset of action (up to 12 weeks)
• Side effects leading to patient non-compliance
• Potential overexposure to preservatives

The proposed solution addresses these issues head-on. The faster onset of action (4 weeks) could significantly improve patient experience and adherence. Moreover, the Optejet's ability to deliver an effective dose with 80% less drug volume is a game-changer, potentially reducing preservative-related side effects.

The lower incidence of corneal irritation is particularly noteworthy. This side effect often leads to treatment discontinuation, so mitigating it could dramatically improve long-term patient outcomes.

However, it's important to await clinical trial results to confirm these benefits in a larger patient population. If successful, this combination therapy could indeed revolutionize dry eye treatment, offering relief to millions of patients more quickly and with fewer side effects.

Market Research Analyst

The collaboration between Eyenovia and SGN Nanopharma taps into a substantial and growing market opportunity. With an estimated 35 million people affected by dry eye disease in the U.S., including a third of all diabetics, the potential patient base is significant.

Key market insights:

• U.S. addressable market: $3 billion annually
• Cyclosporine-based therapeutics: $2.35 billion of the total market
• 16 million formally diagnosed patients

These figures underscore the substantial commercial potential for an improved dry eye treatment. The current market leader's success, despite its limitations, demonstrates strong demand for effective solutions.

However, market penetration will depend on several factors:

• Pricing strategy relative to existing treatments
• Insurance coverage and reimbursement policies
• Marketing efforts to educate both physicians and patients
• Potential for expanding the diagnosed patient base

If the collaboration yields a product with demonstrably superior efficacy and tolerability, it could not only capture a significant share of the existing market but also potentially expand it by encouraging more patients to seek treatment.

Investors should monitor the progress of clinical trials and regulatory approvals, as these will be critical milestones in realizing the market potential of this collaboration.

The U.S. addressable market for Dry Eye Disease is valued at over $3 billion by independent sources

NEW YORK, July 30, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, and SGN Nanopharma, today announced that the companies have entered into a collaboration agreement to develop a treatment for chronic dry eye disease.

Under the terms of the agreement, the companies will work to develop SGN’s Micellar Nanoparticle Platform (MNP) platform-based cyclosporine formulation for use with Eyenovia’s Optejet^® dispenser. The companies are currently validating the novel drug-device combination product's manufacturability to support clinical testing and will then schedule a consultation meeting with the FDA to discuss clinical development.

It has been estimated by independent sources that as many as 35 million people are affected by dry eye disease in the U.S., including 1/3 of all diabetics. Of these, approximately 16 million have been formally diagnosed. The current standard of care treatment for dry eye is cyclosporine, an immune inhibitor that makes it easier for the body to produce tear fluid by inhibiting the underlying inflammation. Dry eye represents an approximate $3 billion addressable market annually in the U.S., of which approximately $2.35 billion is derived from sales of cyclosporine-based therapeutics.

“Our MNP Cyclosporine was shown to be statistically superior in a head-to-head clinical study versus the current standard of care. The data demonstrates the efficacy of MNP Cyclosporine in as little as four weeks and a lower incidence of side effects such as corneal irritation,” stated Dr. Navdeep Jaikaria, Chairman & Chief Executive Officer of SGN Nanopharma. “With the precision dosing afforded by the Optejet dispenser, we believe we can further improve this promising drug's efficacy and tolerability profile. Our ‘drug-device’ combination therapy with Eyenovia has the potential to be the ‘best-in-class’ and to significantly improve patient outcomes and market penetration in this highly underserved dry eye market. We look forward to working with our partners at Eyenovia, and our investors toward this goal.”

“Notwithstanding the widespread use of cyclosporine-based treatments for dry eye disease, currently available formulations have significant shortcomings, including a delayed onset of action of up to 12 weeks and unpleasant side effects that result in significant patient attrition and non-compliance,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The Optejet dispenser has been shown in prior studies to deliver a therapeutic dose of medication with 80% less drug volume, thereby minimizing exposure to harmful preservatives and improving tolerability. We believe the power of SGN’s MNP platform, when combined with the Optejet, will result in a more efficacious and better tolerated cyclosporine-based treatment that we believe has the potential to become the standard of care in this multi-billion-dollar addressable market.”   

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. 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 Proprionate Ophthalmic Suspension 0.05%

About SGN Nanopharma, Inc.

SGN Nanopharma (https://sgnnanopharma.com/) is an innovation-led, clinical-stage, nanopharmaceutical company focused on creating impactful, best-in-class nanotherapeutics targeting large unmet medical needs while reducing the cost and time to commercialization. Chronic diseases continue to be underserved by the current, prevalent mono-therapeutic approaches (which are partially effective at best), creating persisting unmet medical needs. Our objective is to select for and bring to market clinically differentiated, superior combination nanomedicines that mitigate unmet medical needs in large therapeutic areas to create maximal patient impact.

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 estimated market opportunities for our product candidates and platform technology, and the timing for availability and sales growth 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.
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

SGN Nanopharma Contact:

Vineet Singhal
Chief Operating Officer
Vineets@sgn.bio

FAQ

What is the collaboration between Eyenovia and SGN Nanopharma for?

Eyenovia (EYEN) and SGN Nanopharma are collaborating to develop a novel treatment for chronic dry eye disease, combining SGN's Micellar Nanoparticle Platform cyclosporine formulation with Eyenovia's Optejet® dispenser.

How large is the U.S. addressable market for dry eye disease that Eyenovia (EYEN) is targeting?

The U.S. addressable market for dry eye disease is valued at over $3 billion, according to independent sources mentioned in the press release.

What advantages does the Eyenovia (EYEN) Optejet dispenser offer for dry eye treatment?

The Optejet dispenser has been shown to deliver a therapeutic dose of medication with 80% less drug volume, potentially minimizing exposure to harmful preservatives and improving tolerability in dry eye treatment.

How does SGN's MNP Cyclosporine perform compared to current dry eye treatments?

SGN's MNP Cyclosporine was shown to be statistically superior in a head-to-head clinical study versus the current standard of care, demonstrating efficacy in as little as four weeks and a lower incidence of side effects such as corneal irritation.