Formosa Pharmaceuticals and Saval Corporation Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Post-Operative Inflammation and Pain

TAIPEI, April 25, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with Laboratorios Saval ("Saval"), a Chilean-based pharmaceutical company operating in Central and South America, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery.  Saval, a family-owned pharmaceutical company founded in 1938, boasts its own internal R&D and GMP manufacturing facilities, while holding international strategic partners. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007), approved by the U.S. Food and Drug Administration (FDA) in March, 2024, was launched in the United States in September.  The licensing agreement includes upfront payment and milestones, with additional considerations throughout the term of the agreement.

APP13007's active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform.  The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain.  In a recent US survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (...