NEW YORK—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, has announced that its strategic partner, Taiwan-based Formosa Pharmaceuticals, was granted a Taiwan export license for clobetasol propionate ophthalmic suspension 0.05% to allow for shipment of commercial product to the U.S. Eyenovia said it is planning for a U.S. launch for clobetasol later this month. Clobetasol is a steroid approved in the U.S. for reducing inflammation and pain following ocular surgery. 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, Calif., and a member of the Eyenovia scientific advisory board. “Clinical studies have shown that 80 percent of patients experienced rapid, complete relief from postsurgical pain within four days of the procedure, and 60 percent achieved total resolution of inflammation within 15 days after surgery. From a safety perspective, fewer than 1 percent of patients experienced an increase in eye pressure, a side effect of concern to ocular surgeons and commonly associated with steroids.”