Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration (FDA) for its new formulation of the steroidal eye drug clobetasol propionate (0.05%), designed to treat post-operative inflammation and pain following ocular surgery. The drug will be commercialized in the US by Eyenovia Inc., (Nasdaq: EYEN) pursuant to a deal signed in August 2023.
Leveraging its proprietary APNT platform, Formosa has developed a clobetasol propionate ophthalmic suspension with reduced particle size. This innovation results in a drug with enhanced uniformity and purity, improved stability and dispersion properties, and greater bioavailability. The approval marks the first new ophthalmic steroid to enter the US market in over 15 years. Eyenovia is optimistic about the product’s commercial potential, citing a convenient twice-daily dosing regimen, which is more favorable compared to the up to four times daily dosing required for other post-surgical topical ophthalmic treatments. With nearly 7 million ocular surgeries performed in the US each year, the market potential for this new formulation is significant.- Flcube.com