Formosa Pharmaceuticals, AimMax Therapeutics unveiled data from CPN-301, the first of two pivotal Phase 3 clinical studies of APP13007, a novel ophthalmic nanosuspension formulation of a potent corticosteroid, clobetasol propionate (0.05%).
Formosa Pharmaceuticals Inc. and AimMax Therapeutics Inc. have reported successful top-line results from CPN-301, the first of two pivotal Phase 3 clinical studies of APP13007, a novel ophthalmic nanosuspension formulation of a potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain after cataract surgery.
According to the companies, CPN-301 was a randomly assigned, double-masked trial in the United States of APP13007 versus matching placebo (1:1 ratio) in 378 subjects following cataract surgery. The primary endpoints are complete and sustained resolution of ocular inflammation and pain after cataract surgery.
"We are extremely encouraged to observe the clinical outcome of this novel formulation of clobetasol propionate and are appreciative of the painstaking efforts of our clinical team at AimMax Therapeutics and the clinical investigators for achieving this latest milestone of APP13007," said Erick Co, PhD, Formosa Pharmaceuticals' CEO.
Treatment with an APP13007 eyedrop twice daily for 14 days met the two primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically and clinically superior to placebo.
There were 26.5% of subjects who showed sustained anterior chamber cell (ACC) count = 0 (inflammation free) from post-operative day 8 (POD8) through POD15 in the APP13007 arm as compared to 5.1% in the placebo arm (p<0.001). A total of 58.6% of subjects had ACC count = 0 on POD15 following APP13007 treatment as compared to 15.7% following placebo treatment (p<0.001).
Sixty-eight percent (68.0%) of subjects showed sustained ocular pain grade = 0 (pain free) as early as POD4 through to POD15 in the APP13007 arm as compared to 23% in the placebo arm (p<0.001). A total of 77.3% of subjects on APP13007 were ocular pain free at POD4 as compared to 43.7% on placebo (p<0.001).