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 (<2%) were highlighted as key drivers to prescribing APP13007.  APP13007 anticipates having significant potential in Saval's territories, whose ophthalmic corticosteroid market is estimated at almost USD $7.5 million, currently led by treatments with a less convenient dosing regimen (4 to 6 times daily).

"We are pleased that Saval has identified APP13007 as a worthy therapy to include in their ophthalmology core business unit.  Saval's vast network throughout Latin America will guarantee that patients recovering from ocular surgery will have access to APP13007." said Erick Co, President and CEO of Formosa Pharmaceuticals.

"At Saval we are committed to providing patients with affordable and high-quality products in a broad range of therapeutic areas throughout Latin America. Ophthalmology is part of our core and APP13007 will provide physicians and patients with an innovative and valuable addition to the available treatment options.  We are pleased to partner with Formosa Pharmaceuticals and look forward to working together for Latin American patients and physicians" said Nicolás Donoso, CEO of Laboratorios Saval.

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology.  The company's proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.  Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in safety, delivery, and penetration to target tissues.  For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

About Saval Corporation:

Laboratorios Saval S.A. is based in Santiago, Chile and currently is present in 14 countries in Central and South America. For more than 85 years, Saval has provided patients and physicians with affordable and high-quality products in multiple therapeutic areas. For more information, please refer to www.savalcorp.com.

SOURCE Formosa Pharmaceuticals Inc.,