Formosa Pharmaceuticals, in collaboration with its licensee Grand Pharma, has announced positive top-line results from the Phase 3 CPN-303 trial evaluating APP13007 for the treatment of inflammation and pain following cataract surgery in Chinese patients. The randomized, double-blind study compared APP13007 to placebo in 255 subjects and met its primary endpoints with clinically and statistically significant results.
Key Findings from the CPN-303 Trial
The CPN-303 trial assessed the efficacy and safety of APP13007, a novel ophthalmic nanosuspension formulation of clobetasol propionate (0.05%), in resolving ocular inflammation and pain post-cataract surgery. The primary endpoints were complete and sustained resolution of ocular inflammation, defined as an anterior chamber cell (ACC) count of 0 from post-operative day 8 (POD8) through POD15, and ocular pain grade = 0 from POD4 through POD15.
APP13007, administered as an eyedrop twice daily for 14 days, demonstrated superior efficacy compared to placebo. Specifically, 31.8% of subjects in the APP13007 group achieved an ACC count of 0 from POD8 through POD15, compared to 20.0% in the placebo group (p<0.05). Furthermore, 91.2% of subjects treated with APP13007 were free of ocular pain by POD4 and remained pain-free through POD15, whereas only 55.3% of subjects in the placebo group achieved the same outcome (p<0.001).
Safety and Tolerability
The treatment was well tolerated, with a safety profile similar to that of placebo. The pharmacokinetic profile was also consistent with expectations, reinforcing the drug's suitability for post-operative use.
Implications for Post-Cataract Care
"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.
These results align with previous Phase 3 studies conducted in the United States, suggesting consistent efficacy and safety across different patient populations. With the prevalence of cataract surgery and the need for effective post-operative management, APP13007 represents a valuable option for healthcare professionals.
