TAIPEI - Formosa Pharmaceuticals, Inc. (6838.TW) reports completion and successful top-line results from CPN-303, a Phase 3 clinical study of APP13007 (GPN00833), conducted in Chinese cataract surgery patients by licensee, Grand Pharma (0512.HK).
APP13007, a novel ophthalmic nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), was recently approved and launched in the United States for the treatment of post-operative inflammation and pain following ocular surgery. Grand Pharma obtained exclusive rights from Formosa Pharma in 2021 for the commercialization of APP13007 in Mainland China, Hong Kong and Macau.
CPN-303 is a randomized, double-blind trial in China that evaluated APP13007 versus matching placebo (2:1 ratio) in 255 subjects following cataract surgery. Similar to Phase 3 studies, CPN-301 and CPN-302, completed in the United States in 2022, the primary endpoints were complete and sustained resolution of ocular inflammation and pain after cataract surgery, i.e.., anterior chamber cell (ACC) count = 0 from post-operative day 8 (POD8) through POD15 and ocular pain grade = 0 from POD4 through POD15. Treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were clinically and statistically superior to placebo. A total of 31.8% of subjects had ACC count = 0 on POD8 through POD15 following APP13007 treatment as compared to 20.0% following placebo treatment (p
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