The U.S. Food and Drug Administration (FDA) has recently granted approval for Eyenovia’s eye drops, aimed at reducing inflammation and pain in patients post-eye surgery, as confirmed by Taiwan-based Formosa Pharmaceuticals on Monday. Eyenovia obtained the U.S. commercial rights for this drug from Formosa last August.
This innovative treatment, containing the potent topical steroid clobetasol propionate, has traditionally been utilized for managing skin conditions like eczema and psoriasis. However, this marks the first instance of its application in treating eye diseases.
Eyenovia is diligently working towards launching the product by mid-year and aims to secure a significant share of the estimated $1.3 billion annual market opportunity, as stated by Eyenovia CEO Michael Rowe. However, neither Formosa nor Eyenovia has disclosed details regarding pricing or the brand name for the eye drops.
The FDA’s approval follows data from two late-stage studies conducted by Formosa among patients who underwent cataract surgery. These studies demonstrated that the eye drops, known as APP13007, when administered twice a day for two weeks, effectively reduced post-surgical eye inflammation and pain.
It’s noteworthy that Canada-based Bausch + Lomb’s Lotemax, prescribed three times a day, is also FDA-approved for managing inflammation and pain post-eye surgery.
This development underscores the growing importance of innovative treatments in addressing unmet medical needs, particularly in the realm of ophthalmology. The approval of Eyenovia’s eye drops signifies a significant advancement in improving post-surgical outcomes for patients undergoing eye procedures.
