Formosa Pharma and Eyenovia to Co-Develop Clobetasol Propionate Ophthalmic Suspension for Acute Dry Eye in US

Pharmaceuticals has announced the signing of a non-binding terms agreement with Eyenovia, Inc., aiming to co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% for short-term relief of dry eye disease. Both companies will engage in due diligence processes to solidify a definitive agreement, which will encompass shared developmental costs and profit division upon commercialization.

This new agreement is set to build upon an earlier collaboration established in February 2023. The initial partnership focused on testing clobetasol propionate in the Optejet® device and included discussions with the FDA about dry eye indications. Clobetasol propionate, an effective steroid, was approved by the FDA on March 4, 2024, for reducing inflammation and pain associated with ocular surgeries in the U.S., which number an estimated seven million annually. The intended new indication for acute dry eye could broaden its use among millions who experience flare-ups. According to the American Academy of Ophthalmology, around 80% of dry eye patients suffer from flare-ups, and IQVIA data suggests that about two million people in the U.S. are treated with prescription medications for dry eye.

The Clobetasol Propionate Ophthalmic Nanosuspension, 0.05% is the first product developed through Formosa's APNT® nanoparticle formulation platform. This proprietary technology minimizes the particle size of active pharmaceutical ingredients, enhancing their uniformity and purity. This, in turn, allows better penetration into relevant eye compartments and increases bioavailability.

Erick Co, President and CEO of Formosa Pharmaceuticals, expressed enthusiasm about advancing their partnership with Eyenovia. He stated, "We have already demonstrated the compatibility of our technologies, and realizing APNT® formulations in advanced delivery devices like Optejet® presents a tremendous opportunity for both companies." Michael Rowe, CEO of Eyenovia, added, "Clobetasol propionate ophthalmic suspensions offer a unique profile that could benefit dry eye patients significantly. The drug’s effectiveness in pain and inflammation relief, coupled with its low incidence of adverse events, may provide substantial relief to millions suffering from periodic flare-ups. We at Eyenovia look forward to advancing this project with Formosa and integrating it into our Optejet® dispenser technology."

Formosa Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on ophthalmology and oncology. The company uses its proprietary nanoparticle formulation technology, APNT®, to enhance the dissolution and bioavailability of active pharmaceutical ingredients for topical, oral, and inhaler administration. Formulations developed through APNT® achieve high uniformity, purity, and stability, allowing the effective utilization of poorly soluble or highly potent drug agents.

Eyenovia, Inc. is a company specializing in ophthalmic technology and is commercializing Mydcombi™ for mydriasis and clobetasol propionate ophthalmic suspension for postsurgical inflammation and pain. Additionally, Eyenovia is developing the Optejet® device for its therapeutic products for pediatric progressive myopia and other indications.

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