Formosa Pharmaceuticals announced on the 4th that its licensed partner, Yunda Pharmaceutical, has successfully met the endpoints in the Phase III clinical trial (trial code CPN-303) of APP13007, a new drug for the treatment of post-cataract surgery inflammation, conducted in China.
APP13007 is a novel formulation developed using Formosa Pharmaceuticals' proprietary APNTR nanoparticle platform, with the potent corticosteroid clobetasol propionate as its active ingredient. The drug has already received FDA approval for treating inflammation and pain following eye surgeries and was launched in the United States in September 2024. In 2021, Yunda Pharmaceutical signed an exclusive licensing agreement with Formosa Pharmaceuticals for the commercialization of APP13007 in China, Hong Kong, and Macau.
The CPN-303 trial was a multi-center, double-blind, placebo-controlled Phase III clinical trial conducted in China, involving 255 patients who had undergone cataract surgery. Participants were randomly assigned in a 2:1 ratio to receive either the study drug or a placebo. The trial aimed to evaluate the efficacy and safety of APP13007 (Yunda’s code GPN00833) for treating post-surgery inflammation and pain in the Chinese population.
Formosa Pharmaceuticals stated that the design of this new drug trial is similar to the Phase III trials CPN-301 and CPN-302 completed in the United States in 2022. In the treatment group, patients were given two doses of APP13007 eye drops daily for 14 days. The primary efficacy endpoints were the proportion of patients who achieved complete resolution of postoperative eye inflammation and full pain relief, sustained through the end of the treatment course. The inflammation endpoint was defined as having a 0 anterior chamber cell (ACC) count from Day 8 to Day 15 post-surgery.
The results showed that the 14-day, twice-daily regimen of APP13007 rapidly and persistently cleared eye inflammation, demonstrating statistically and clinically significant superiority over the placebo. In the APP13007 group, 31.8% of patients had a 0 ACC count from Day 8 to Day 15, compared to only 20.0% in the placebo group (p<0.05). Additionally, 91.2% of patients in the APP13007 group achieved complete pain relief by Day 4 post-surgery, with no recurrence until Day 15, significantly higher than the 55.3% in the placebo group (p<0.001).
The trial also showed that APP13007 had good tolerability, with a safety profile similar to that of the placebo. Pharmacokinetic data also met expectations.
CEO Dr. Erick Co expressed his excitement about the results and looks forward to collaborating with Yunda Pharmaceutical to drive the commercialization of APP13007 in the Greater China region.
Resource (mandarin): 台新藥眼科用藥APP13007再報喜！大陸三期試驗數據達標
