Eyenovia, Inc., known as EYEN, announced on Tuesday that the FDA has approved clobetasol propionate ophthalmic suspension eye drops developed by Taiwan's Formosa Pharmaceuticals. This PBS approval is significant because it's the first medication that harnesses Formosa's APNT technology to treat inflammation and pain after eye surgery.
The endorsement from the FDA is underpinned by two substantial Phase III trials. Almost 750 patients participated in these rigorous and well-controlled trials, which were random, two-fold-masked, and placebo-controlled in design.
Eyenovia secured the U.S. commercial rights to this product from Formosa Pharmaceuticals in August 2023. The total transaction, encompassing an upfront payment as well as development and sales milestones, carried a worth of $86 million.
Taking their business strategy forward, Eyenovia aims to launch the product by the middle of the year. The estimated market potential for the product stands at a staggering $1.3 billion annually.
