Eyenovia and Formosa Begin Developing Clobetasol Propionate for U.S. Dry Eye Treatment

On August 7, 2024, Eyenovia, Inc., a commercial-stage ophthalmic company with two FDA-approved products, announced a new partnership with Formosa Pharmaceuticals, a Taiwan-based company. The two companies signed a non-binding agreement to co-develop a formulation of clobetasol propionate ophthalmic suspension 0.05% in combination with Eyenovia's Optejet device. This formulation aims to provide short-term relief for dry eye disease.

Eyenovia and Formosa Pharmaceuticals will conduct due diligence and aim to finalize a definitive agreement. The finalized contract is expected to include shared development costs and a division of profits upon commercialization. This new agreement builds upon a collaboration established in February 2023, which included testing clobetasol propionate with the Optejet device and planning an FDA consultation about its potential for dry eye treatment.

Clobetasol propionate, a potent steroid, received FDA approval on March 4, 2024, for reducing inflammation and pain following ocular surgeries. The U.S. market for topical ocular steroids and steroid combinations currently generates around $1.3 billion in sales annually. Adding an indication for acute dry eye could significantly expand the usage of clobetasol propionate, benefiting millions of people who suffer from periodic flare-ups despite existing treatments.

Michael Rowe, CEO of Eyenovia, highlighted the unique profile of clobetasol propionate, noting its efficacy in pain and inflammation relief and its low incidence of adverse events. He expressed optimism that the drug could significantly benefit dry eye patients who experience occasional flare-ups. Rowe also emphasized the company's enthusiasm for advancing the project with Formosa and leveraging their Optejet dispenser technology.

Erick Co, President and CEO of Formosa Pharmaceuticals, echoed this sentiment, expressing eagerness to advance the partnership. He noted that the compatibility of their respective technologies has already been demonstrated. Co highlighted the potential for successfully developing APNT® formulations for advanced delivery devices like the Optejet, viewing it as a significant opportunity for both companies.

The ophthalmic suspension of clobetasol propionate 0.05% is the first product developed using Formosa’s proprietary APNT® nanoparticle formulation platform. This platform reduces the particle size of active pharmaceutical ingredients, ensuring high uniformity and purity. The technology allows for better penetration into relevant compartments of the eye, ultimately enhancing bioavailability.

Eyenovia, Inc. is known for commercializing Mydcombi™ (a combination of tropicamide and phenylephrine hydrochloride ophthalmic spray) for mydriasis, and clobetasol propionate ophthalmic suspension 0.05% for post-surgical inflammation and pain. The company also develops the Optejet® device for pediatric progressive myopia and other potential indications through out-licensing.

Through this new collaboration, both Eyenovia and Formosa Pharmaceuticals aim to bring innovative solutions to the ophthalmic market, potentially transforming the treatment landscape for dry eye disease and other ocular conditions.