Eyenovia, Inc. 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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