US FDA approves Eyenovia's eye drug, Formosa Pharma says

[March 05, 2024]  (Reuters) -The U.S. Food and Drug Administration had approved Eyenovia's eye drops to reduce inflammation and pain in patients who have undergone eye surgery, Taiwan-based Formosa Pharmaceuticals said on Monday.

Eyenovia acquired U.S. commercial rights of the drug last August from Formosa.

The treatment, which contains potent topical steroid clobetasol propionate, is typically used to treat skin conditions such as eczema and psoriasis.

The steroid has so far not been used to treat eye diseases.

Eyenovia is working to launch the product mid-year, and seeks to capture a significant share of an estimated $1.3 billion annual market opportunity, Eyenovia CEO Michael Rowe said.

Formosa did not provide details on the pricing or the brand name for the eye drops, while Eyenovia did not immediately respond to Reuters' request for comments.

The U.S. FDA's approval came in following data from two late-stage studies conducted by Formosa in patients who had undergone cataract surgery.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

In both studies, the drops - known as APP13007 - were administered twice a day for two weeks and helped reduce post-surgical eye inflammation and pain.

Canada-based Bausch + Lomb's Lotemax, used thrice a day, is also approved by the U.S. health regulator to treat inflammation and pain after eye surgery.

(Reporting by Sriparna Roy, Sneha S K and Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar, Shounak Dasgupta and Sherry Jacob-Phillips)

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