TAIPEI, Nov. 4, 2024 /PRNewswire/ -- 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<0.05). Additionally, 91.2% of subjects on APP13007 were free of ocular pain (ocular pain = 0) by POD4 and remained pain-free through POD15, as compared to only 55.3% of subjects taking placebo (p<0.001).
APP13007 treatment was well tolerated with a safety profile similar to that of placebo and the pharmacokinetic profile also aligned with expectations.
“Formosa Pharma congratulates our partners at Grand Pharma on their successful and swift execution of this Phase 3 study in Chinese patients. We are pleased to note that the results of their trial are consistent with observations and outcomes of our United States trials. We look forward to working with Grand Pharma toward their commercial launch in China.” said Erick Co, Ph.D., President and CEO of Formosa Pharmaceuticals.
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.
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