Formosa Pharmaceuticals Announces Top-Line Results from Phase 3 Trial of APP13007 in China

Formosa Pharmaceuticals recently announced the completion of CPN-303, a Phase 3 clinical trial conducted in Chinese cataract surgery patients to evaluate APP13007 (GPN00833). This trial, managed by Formosa’s licensee Grand Pharma (0512.HK), demonstrated positive top-line results, showcasing APP13007’s effectiveness in treating post-operative inflammation and pain.

About APP13007: A Novel Ophthalmic Nanosuspension

APP13007 is an innovative ophthalmic nanosuspension containing clobetasol propionate (0.05%), a potent corticosteroid. Approved and launched in the U.S., APP13007 is used for managing inflammation and pain after ocular surgeries. Formosa granted Grand Pharma exclusive rights to commercialize APP13007 in Mainland China, Hong Kong, and Macau in 2021. In the U.S., Eyenovia holds commercial rights acquired in 2022, while Apotex Inc. has exclusive commercialization rights in Canada.

Phase 3 CPN-303 Trial Design and Endpoints

The CPN-303 study is a randomized, double-blind trial evaluating APP13007 against a matching placebo (2:1 ratio) in 255 cataract surgery patients in China. The study’s primary endpoints were:

       • Complete and sustained resolution of ocular inflammation

       • Reduction in post-surgical ocular pain

These endpoints align with those from CPN-301 and CPN-302 Phase 3 studies completed in the United States in 2022.

Positive Results: APP13007 Achieves Both Primary Endpoints

Results from CPN-303 showed that APP13007, administered as an eyedrop twice daily for 14 days, met its primary endpoints by significantly reducing ocular inflammation and pain:

       • Pain-Free Results: 91.2% of APP13007-treated patients reported being pain-free by day 4 post-surgery, remaining so through day 15. By comparison, only 55.3% of the placebo group were pain-free (p<0.001).

These findings underscore the treatment's rapid and lasting efficacy in managing post-surgical discomfort.

Executive Remarks on Trial Success and Future Launch

Dr. Erick Co, PhD, President and CEO of Formosa Pharmaceuticals, praised the successful trial execution:

“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.”

With these results, Formosa and Grand Pharma are well-positioned to advance APP13007 toward commercialization in China, expanding access to this effective post-surgical treatment.