Formosa Pharmaceuticals announced today (6th) that its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension 0.05% (APP13007), has successfully obtained a special export license from Taiwan's Food and Drug Administration (TFDA). The company plans to complete its first shipment to its U.S. licensing partner, Eyenovia, Inc. (NASDAQ: EYEN), within this month. Eyenovia aims to launch the drug in the U.S. market by the end of September.

APP13007 is a novel ophthalmic drug that combines the ultra-potent corticosteroid Clobetasol Propionate with Formosa Pharmaceuticals’ proprietary APNT nanoparticle formulation platform. It is the first clobetasol-based drug approved by the U.S. FDA for ocular use. With approximately 7 million eye surgeries performed annually in the U.S., the market for ophthalmic steroids and steroid combinations is valued at around $1.3 billion. With the acquisition of this export license, Formosa Pharmaceuticals and Eyenovia are officially entering this lucrative market.

Dr. Francis S. Mah, Director of Cornea Services at Scripps Clinic in La Jolla, California, and a member of Eyenovia's Scientific Advisory Board, noted that clobetasol propionate ophthalmic suspension represents the first new active ingredient approved for ophthalmic steroid use in 15 years. Clinical studies have shown that nearly 90% of patients experienced complete relief from post-operative pain within 15 days, and 60% achieved complete resolution of inflammation. Additionally, less than 1% of patients experienced a sudden increase in intraocular pressure, a common side effect of other steroid eye drops.

Formosa Pharmaceuticals is actively preparing for the first shipment of the drug and will continue to fulfill orders based on production schedules. Eyenovia plans to complete the commercial launch of Clobetasol Propionate Ophthalmic Suspension in the U.S. by the end of September.

Resource (mandarin): 台新藥眼科新藥美國首批出貨在即，目標本月底完成上市銷售