Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics 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. 

CPN-301 was a randomized, 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. 

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. 

APP13007 treatment was well tolerated with a safety profile similar to that of placebo.  There were no serious adverse events, and the treatment-emergent adverse events were mainly ocular events commonly seen after cataract surgery.  Both the APP13007 and placebo treatments had comparable profiles of change in intraocular pressure (IOP) from baseline. 

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, Ph.D., Formosa Pharmaceuticals' Chief Executive Officer.