Eyenovia Announces Taiwan Export License Approval to Commence Shipment of Clobetasol Propionate Ophthalmic Suspension (0.05%) to the U.S.

Rhea-AI Summary

Eyenovia (NASDAQ: EYEN) has announced that its partner, Formosa Pharmaceuticals, received a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05%. This approval allows for shipment of the product to the U.S., with a planned launch in late September 2024. Clobetasol is a powerful steroid for reducing inflammation and pain after ocular surgeries, entering a $1.3 billion market for topical ocular steroids. Clinical studies showed that 80% of patients experienced rapid relief from postsurgical pain within four days, and 60% achieved total resolution of inflammation within 15 days. Eyenovia plans to offer competitive pricing to enhance affordability for all patients.

Positive

• Received Taiwan Export License for clobetasol propionate, allowing U.S. shipment
• Planned U.S. launch in late September 2024
• Entering a $1.3 billion market for topical ocular steroids
• 80% of patients experienced rapid pain relief within 4 days in clinical studies
• 60% of patients achieved total inflammation resolution within 15 days
• Competitive pricing strategy to enhance affordability

Negative

• None.

Insights

Financial Analyst

The approval of Taiwan's Export License for clobetasol propionate is a significant milestone for Eyenovia (NASDAQ: EYEN). This paves the way for the company's planned U.S. launch in September 2024, potentially opening up a $1.3 billion market opportunity in topical ocular steroids. The product's competitive advantages, including twice-daily dosing and competitive pricing, could drive strong market adoption. However, investors should note that market penetration and revenue generation will depend on factors such as marketing effectiveness and acceptance by healthcare providers. The 80% rapid pain relief and 60% inflammation resolution rates are promising, but real-world performance will be important for long-term success.

Medical Research Analyst

Clobetasol's approval as the first new ophthalmic steroid in over 15 years is noteworthy. The clinical data showing rapid pain relief and inflammation resolution is impressive, particularly the low incidence (1%) of increased eye pressure - a common concern with steroid use. This favorable safety profile could be a key differentiator in the market. The twice-daily dosing regimen also offers a significant advantage over competitors requiring up to four daily doses. However, it's important to monitor post-market surveillance data to confirm these benefits in a broader patient population. The product's potential to become a leading choice for postsurgical care is promising, but its long-term efficacy and safety profile will ultimately determine its market position.

Market Research Analyst

Eyenovia's strategic partnership with Formosa Pharmaceuticals and the subsequent export license approval demonstrate effective global collaboration in bringing innovative treatments to market. The company's focus on competitive pricing is smart, addressing one of the top concerns of ophthalmic surgeons. This approach could drive rapid adoption, especially if it translates to better insurance coverage and patient affordability. The timing of the launch in September 2024 gives Eyenovia ample time for market preparation and education of healthcare providers. However, success will hinge on effective marketing strategies and the ability to differentiate clobetasol from established treatments. The company should also be prepared for potential competitive responses from incumbent players in this lucrative market.

Eyenovia is planning for a U.S. launch for Clobetasol in late September 2024

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced that its strategic partner, Taiwan-based Formosa Pharmaceuticals (TWO:6838), was granted a Taiwan Export License for clobetasol propionate ophthalmic suspension 0.05% (“clobetasol propionate”) to allow for shipment of commercial product to the U.S.

Clobetasol is a powerful steroid approved for reducing inflammation and pain following the approximately seven million ocular surgeries performed annually in the U.S. In August 2023, Eyenovia secured exclusive rights to distribute and sell clobetasol in the U.S., entering a market for topical ocular steroids and steroid combinations valued at approximately $1.3 billion annually.

“Clobetasol is the first new ophthalmic steroid to be approved in the U.S. in over 15 years, with benefits that may position it as a leading choice for postsurgical care,” said Dr. Francis S. Mah, Director of the Cornea Service at Scripps Clinic in La Jolla, California and member of the Eyenovia Scientific Advisory Board. “Clinical studies have shown that 80% of patients experienced rapid, complete relief from postsurgical pain within four days of the procedure, and 60% achieved total resolution of inflammation within 15 days after surgery. From a safety perspective, fewer than 1% of patients experienced an increase in eye pressure, a side effect of concern to ocular surgeons and commonly associated with steroids.”

A recent survey of 100 ophthalmic surgeons highlighted efficacy and cost as the two most important factors when choosing a treatment for postoperative inflammation and pain. Clobetasol's proven efficacy, allowing for just twice-daily dosing, offers an easier regimen versus other treatments that require up to four doses per day plus titration. Additionally, Clobetasol will be competitively priced to enhance affordability for all patients, regardless of their insurance coverage.

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About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet^® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as out-licensing for additional indications. At Eyenovia, our vision is to improve yours. 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 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.
Andrew 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

When is Eyenovia (EYEN) planning to launch clobetasol propionate in the U.S.?

Eyenovia is planning to launch clobetasol propionate in the U.S. in late September 2024.

What is the market value for topical ocular steroids that Eyenovia's (EYEN) clobetasol propionate is entering?

Eyenovia's clobetasol propionate is entering a market for topical ocular steroids and steroid combinations valued at approximately $1.3 billion annually.

What percentage of patients experienced rapid pain relief with Eyenovia's (EYEN) clobetasol propionate in clinical studies?

In clinical studies, 80% of patients experienced rapid, complete relief from postsurgical pain within four days of the procedure using clobetasol propionate.

How does Eyenovia (EYEN) plan to price clobetasol propionate for the U.S. market?

Eyenovia plans to competitively price clobetasol propionate to enhance affordability for all patients, regardless of their insurance coverage.