Eyenovia Congratulates Formosa Pharmaceuticals on FDA Approval of Clobetasol Propionate Ophthalmic Suspension 0.05% for the Treatment of Post-operative Inflammation and Pain Following Ocular Surgery

Approval based on nearly 9 out of 10 patients achieving complete absence of post-surgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post-ocular surgery

Eyenovia plans to launch in the U.S. as soon as this summer using its Mydcombi sales force providing pre-surgical pupil dilation and post-surgical care in an estimated $1.3 billion annual U.S. market

NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today congratulates Formosa Pharmaceuticals (TWO:6838) on the FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of post-operative inflammation and pain following ocular surgery. Eyenovia acquired the U.S. commercial rights to clobetasol propionate ophthalmic suspension 0.05% from Formosa Pharmaceuticals in August 2023.

Formosa’s proprietary APNT technology, which has been used in the development of clobetasol propionate ophthalmic suspension to reduce the particle size of the active pharmaceutical ingredient, is thought to provide many benefits, including high uniformity and purity, improved stability, improved dispersion properties and greater bioavailability.

“We congratulate Formosa Pharmaceuticals on the FDA approval of clobetasol propionate ophthalmic suspension 0.05%, the first approved therapeutic to leverage its APNT formulation platform, and the first new ophthalmic steroid to enter the U.S. market in over 15 years,” stated Michael Rowe, Eyenovia’s Chief Executive Officer. “The efficacy profile of clobetasol propionate ophthalmic suspension 0.05% is highly desirable, and adverse events were seen in no more than 2% of patients; many of the adverse events may have been caused by the surgical procedure itself. Moreover, we believe its efficacy, safety, and convenient dosing regimen – twice daily without titration versus up to four times daily for other post-surgical topical ophthalmic treatment options – will resonate with patients and eye doctors alike for the almost 7 million ocular surgeries that take place in this country every year.”

“In addition to its many favorable clinical attributes, clobetasol propionate ophthalmic suspension 0.05% fits perfectly within our commercial strategy by allowing us to leverage our sales and distribution infrastructure. We are working towards a robust launch mid-year starting with an educational campaign focused on cataract surgeons,” Mr. Rowe concluded.