Formosa Pharma Reports Phase 3 Success of CPN-303 for Post-Cataract Inflammation and Pain in Chinese Patients

Formosa Pharmaceuticals, Inc. has announced the successful completion and positive top-line results from the CPN-303 Phase 3 clinical study of APP13007 (GPN00833). This study was carried out in Chinese patients undergoing cataract surgery by Grand Pharma, who holds the commercialization rights for the drug in Mainland China, Hong Kong, and Macau.

APP13007 is an innovative ophthalmic nanosuspension containing the corticosteroid clobetasol propionate (0.05%). It was recently approved and launched in the United States to manage post-operative inflammation and pain following ocular surgery. Grand Pharma acquired the exclusive rights to market APP13007 in their territories from Formosa Pharmaceuticals in 2021.

The CPN-303 study is a randomized, double-blind trial that included 255 participants. It compared the effects of APP13007 against a placebo following cataract surgery. The study design mirrored the earlier successful Phase 3 studies, CPN-301 and CPN-302, conducted in the United States in 2022. The primary goals were to achieve complete and sustained resolution of ocular inflammation and pain after surgery. This was measured by the anterior chamber cell (ACC) count reaching zero from post-operative day 8 (POD8) through POD15 and ocular pain grade being zero from POD4 through POD15.

Results showed that treatment with APP13007 eye drops, administered twice daily for 14 days, met both primary endpoints. The drug produced rapid and sustained reduction of ocular inflammation and relief from pain, significantly outperforming the placebo. Specifically, 31.8% of subjects treated with APP13007 had an ACC count of zero from POD8 through POD15, compared with 20.0% in the placebo group (p<0.05). Furthermore, 91.2% of the APP13007 group reported no ocular pain by POD4, remaining pain-free through POD15, in contrast to 55.3% of those on placebo (p<0.001).

The treatment was well tolerated, with a safety profile comparable to placebo. The pharmacokinetic profile also met the anticipated standards.

Erick Co, Ph.D., President and CEO of Formosa Pharmaceuticals, expressed his congratulations to Grand Pharma for the effective and swift execution of the Phase 3 study. He noted that the trial results are consistent with those observed in the United States trials. Co also emphasized the company's eagerness to support Grand Pharma in the commercial launch of APP13007 in China.

Formosa Pharmaceuticals, Inc. is a biotechnology company focused on ophthalmology and oncology. Utilizing its advanced nanoparticle formulation technology (APNT®), the company enhances the dissolution and bioavailability of active pharmaceutical ingredients for various forms of administration, including topical, oral, and inhaler. This technology helps in creating formulations with high uniformity, purity, and stability, facilitating the use of drugs that are either poorly soluble or highly potent, which otherwise might face significant challenges in terms of safety, delivery, and tissue penetration.
 

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