Eyenovia Congratulates Formosa Pharmaceuticals on FDA Approval of Clobetasol Propionate Ophthalmic Suspension 0.05% for the Treatment of Post-operative Inflammation and Pain Following Ocular Surgery

Rhea-AI Summary

Eyenovia celebrates Formosa Pharmaceuticals' FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain. Eyenovia plans a U.S. launch in the $1.3 billion market with Mydcombi™ sales force. The product offers high efficacy, safety, and convenience with a twice-daily dosing regimen.

Insights

Pharmaceutical Industry Analyst

The FDA approval of clobetasol propionate ophthalmic suspension 0.05% represents a significant milestone for Eyenovia and the ophthalmic pharmaceutical market. The approval introduces a new therapeutic option for post-operative care, which is particularly notable given the absence of new entrants in the ophthalmic steroid market for over a decade and a half. The reported efficacy, with a high percentage of patients achieving complete absence of post-surgical pain and inflammation, positions the drug as a potential market leader in this segment.

The use of Formosa's APNT™ technology in the drug's development could signal a competitive advantage in terms of drug delivery and efficacy. Improved bioavailability and stability may translate into better patient outcomes and adherence to treatment regimens. The convenient dosing of twice daily without titration is also likely to be attractive to both patients and physicians, potentially increasing its adoption in the nearly 7 million ocular surgeries performed annually in the U.S.

From a commercial perspective, Eyenovia's strategy to leverage its existing Mydcombi™ sales force for the launch is a prudent move that could optimize market penetration and reduce go-to-market costs. The company's plans to explore further development of the product for dry eye treatment expand its potential market reach, considering the estimated $3.6 billion market size for dry eye treatments.

Medical Research Analyst

The clinical benefits of clobetasol propionate ophthalmic suspension 0.05% are underscored by the high rate of patients experiencing complete absence of post-surgical pain and inflammation. Such outcomes are critical in the post-operative period, not only for patient comfort but also for the prevention of complications that can lead to longer-term visual impairment. The low incidence of adverse events, potentially attributable to the surgery itself, is an encouraging sign of the drug's safety profile.

It's important to consider that the ophthalmic steroid market has been relatively stagnant in terms of innovation. This approval could stimulate further research and development in this area, potentially leading to more advanced treatments. The application of APNT™ technology in ophthalmology may set a new standard for drug formulation, offering a glimpse into the future of ocular therapeutics.

However, it is crucial to monitor post-market surveillance data to validate the long-term safety and efficacy of the drug, as clinical trial conditions often differ from real-world usage. Any new information could impact the drug's market performance and acceptance by the medical community.

Market Research Analyst

The introduction of clobetasol propionate ophthalmic suspension 0.05% into the U.S. market taps into a substantial economic opportunity within the ophthalmic surgery aftercare segment. Eyenovia's targeting of the cataract surgery demographic with an educational campaign is a strategic approach to capture a significant share of the market, especially considering the aging population and the associated rise in cataract prevalence.

Market dynamics such as pricing, insurance coverage and competition from existing treatments will influence the uptake of the new drug. Eyenovia's commercial strategy, including the leveraging of its Mydcombi™ sales force, could provide a cost-effective approach to market entry. The potential expansion into the dry eye market further indicates a strategic approach to diversifying and maximizing the product's lifecycle.

Investors and stakeholders should monitor the product's launch and early adoption rates as indicators of its commercial viability. Additionally, any strategic partnerships or marketing initiatives could play a pivotal role in shaping the product's trajectory in the competitive landscape of ophthalmic treatments.

Approval based on nearly 9 out of 10 patients achieving complete absence of post-surgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post-ocular surgery

Eyenovia plans to launch in the U.S. as soon as this summer using its Mydcombi™ sales force providing pre-surgical pupil dilation and post-surgical care in an estimated $1.3 billion annual U.S. market

NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today congratulates Formosa Pharmaceuticals (TWO:6838) on the FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of post-operative inflammation and pain following ocular surgery. Eyenovia acquired the U.S. commercial rights to clobetasol propionate ophthalmic suspension 0.05% from Formosa Pharmaceuticals in August 2023.

Formosa’s proprietary APNT™ technology, which has been used in the development of clobetasol propionate ophthalmic suspension to reduce the particle size of the active pharmaceutical ingredient, is thought to provide many benefits, including high uniformity and purity, improved stability, improved dispersion properties and greater bioavailability.

“We congratulate Formosa Pharmaceuticals on the FDA approval of clobetasol propionate ophthalmic suspension 0.05%, the first approved therapeutic to leverage its APNT™ formulation platform, and the first new ophthalmic steroid to enter the U.S. market in over 15 years,” stated Michael Rowe, Eyenovia’s Chief Executive Officer. “The efficacy profile of clobetasol propionate ophthalmic suspension 0.05% is highly desirable, and adverse events were seen in no more than 2% of patients; many of the adverse events may have been caused by the surgical procedure itself. Moreover, we believe its efficacy, safety, and convenient dosing regimen – twice daily without titration versus up to four times daily for other post-surgical topical ophthalmic treatment options – will resonate with patients and eye doctors alike for the almost 7 million ocular surgeries that take place in this country every year.”

“In addition to its many favorable clinical attributes, clobetasol propionate ophthalmic suspension 0.05% fits perfectly within our commercial strategy by allowing us to leverage our sales and distribution infrastructure. We are working towards a robust launch mid-year starting with an educational campaign focused on cataract surgeons,” Mr. Rowe concluded.

Longer term, Eyenovia is exploring further development of the product in the Optejet dispenser as a potential treatment for dry eye, which the Company estimates to be a $3.6 billion market.

Eyenovia will provide a further update on this and other recent developments, including timing for approval of its tradename for this product, during its fourth quarter and full-year 2023 results conference call in mid-March.

PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for CLOBETASOL PROPRIONATE OPHTHALMIC SUSPENSION 0.05%

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

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic suspension 0.05% to reduce pain and inflammation following ocular surgery, which was approved by the FDA on March 4, 2024.

Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia (Apersure) and myopia progression (MicroPine, partnered with Arctic Vision in China and South Korea).

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 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 products, product candidates and platform technology, and the timing for launch of clobetasol propionate ophthalmic suspension 0.05% and any additional indications for its use,. 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 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

FAQ

What is the FDA approval for clobetasol propionate ophthalmic suspension 0.05% by Formosa Pharmaceuticals?

The FDA approved clobetasol propionate ophthalmic suspension 0.05% for treating post-operative inflammation and pain following ocular surgery.

What is Eyenovia's plan regarding the U.S. market launch of clobetasol propionate ophthalmic suspension 0.05%?

Eyenovia plans to launch the product in the U.S. using its Mydcombi™ sales force in the estimated $1.3 billion market as early as this summer.

What are the benefits of Formosa's APNT™ technology in developing clobetasol propionate ophthalmic suspension?

Formosa's APNT™ technology provides benefits like high uniformity, purity, improved stability, dispersion properties, and greater bioavailability.

What is the dosing regimen for clobetasol propionate ophthalmic suspension 0.05%?

The product offers a convenient dosing regimen of twice daily without titration, compared to up to four times daily for other post-surgical topical ophthalmic treatments.

What is Eyenovia's long-term plan for clobetasol propionate ophthalmic suspension 0.05%?

Eyenovia is exploring further development of the product in the Optejet dispenser as a potential treatment for dry eye, estimated to be a $3.6 billion market.