TAIPEI , Sept. 9, 2024 /PRNewswire/ -- Formosa Pharmaceuticals, Inc. (hereinafter referred to as "Formosa Pharma," 6838.
TW) announced the successful first shipment to the United States of its new ophthalmic drug, Clobetasol Propionate Ophthalmic Suspension, 0.05% (APP13007), manufactured by Bora Pharmaceuticals Ophthalmic (hereinafter referred to as "Bora," 6472.TW).
Formosa Pharma's U.S. partner, Eyenovia, Inc.
(NASDAQ: EYEN ), has initiated the pre-launch activities for APP13007 and is expected to begin commercialization in late September. APP13007, developed through Formosa Pharma's proprietary APNT ® nanotechnology platform, is the first drug approved by the U.S.
FDA for ophthalmic use utilizing the super-potent corticosteroid, clobetasol propionate. Almost 7 million ophthalmic surgeries are performed annually in the U.S.
, and the ophthalmic steroid and steroid-combination drug market is valued at USD $1.3 billion . According to a recent survey conducted by Eyenovia of 100 U.
S. ophthalmic surgeons, efficacy and cost were identified as the most important factors when choosing a treatment for postoperative inflammation and pain. APP13007 offers a more convenient dosing regimen with its proven efficacy, requiring only twice-daily administration compared to other treatments that require up to four doses per day.
Having recently obtained the Drug Export License from Taiwan's Food and Drug Administration (TFDA) in late August, Formosa Pharma has coordinated its first US shipme.