Eyenovia, Formosa Gets FDA Approval For Clobetasol Propionate Ophthalmic Eye Drops

(RTTNews) - Eyenovia, Inc. (EYEN) on Tuesday revealed that Taiwan-based Formosa Pharmaceuticals' clobetasol propionate ophthalmic suspension eye drops has received FDA's approval.

This approval marks the first therapeutic to utilize Formosa's APNT technology for treating post-operative inflammation and pain following eye surgery.

The FDA's approval is based on two significant Phase III trials that enrolled almost 750 patients and were randomized, double-masked, and placebo-controlled.

In August 2023, Eyenovia acquired the U.S. commercial rights to the product from Formosa Pharmaceuticals. The total deal package, including upfront payment and development and sales milestones, had a value of $86 million.

The company's objective is to launch the product by mid-year with an estimated $1.3 billion annual market opportunity.