Formosa Pharmaceuticals continues its global expansion, announcing on the 14th that its Swiss and Liechtenstein licensing partner, Medvisis Switzerland AG, has submitted a marketing authorization application for its ophthalmic drug APP13007 (clobetasol propionate ophthalmic suspension 0.05%) to Swissmedic, the Swiss regulatory authority, for the treatment of postoperative ocular inflammation and pain. All regulatory filing costs will be covered by Medvisis.

APP13007 is a novel ophthalmic formulation developed using Formosa Pharmaceuticals' proprietary APNT (Advanced Platform Nano Technology) nanoparticle formulation platform, with clobetasol propionate, a high-potency corticosteroid, as its active ingredient. This innovative formulation, administered twice daily for 14 days, offers rapid and sustained relief from inflammation and pain in a simple and convenient dosing regimen.

At the end of 2024, Formosa Pharmaceuticals signed an exclusive licensing agreement with Medvisis, granting it the exclusive commercialization rights for APP13007 in Switzerland and Liechtenstein. The agreement includes an upfront payment, sales milestone payments, and other financial considerations throughout the contract period.

Switzerland performs over 100,000 cataract surgeries annually, with the corticosteroid market exceeding $2.1 million. The current standard treatment requires four to six doses per day, making APP13007’s twice-daily regimen a competitive advantage in the Swiss market.

To date, Formosa Pharmaceuticals has successfully licensed APP13007 to multiple global partners, including Grand Pharmaceutical Group Limited (China), Eyenovia (U.S.), Cristália (Brazil), Tabuk Pharmaceuticals (Middle East and North Africa), Tzamal (Israel), Apotex (Canada), and Medvisis (Switzerland). Industry analysts anticipate that market approvals will be secured gradually across different regions in 2024 and 2025, with faster approvals expected in the Middle East, North Africa, and Canada.

Resource: 台新藥眼科新藥遍地開花，瑞士授權夥伴申請上市查登