Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. report successful top-line results from CPN-302, the second of the two pivotal Phase 3 clinical studies of APP13007, a novel ophthalmic nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain after cataract surgery. CPN-302 was a randomized, double-masked trial in the United States that evaluated APP13007 versus matching placebo (1:1 ratio) in 370 randomized subjects following cataract surgery (including 151 in a corneal endothelial cell sub-study). As in the first Phase 3 study, CPN-301, the primary endpoints were complete and sustained resolution of ocular inflammation and pain after cataract surgery, i.e., anterior chamber cell (ACC) count = 0 from post-operative day 8 (POD8) through POD15 and ocular pain grade = 0 from POD4 through POD15.  Treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically (p<0.001) and clinically superior to placebo.  A total of 57.8% of subjects had ACC count = 0 on POD15 following APP13007 treatment as compared to 18.9% following placebo treatment (p<0.001).

A total of 85.4% of subjects on APP13007 were ocular pain free as early as at POD4 as compared to 51.4% on placebo (p<0.001). APP13007 treatment was well tolerated with a safety profile similar to that of placebo. There were no study drug-related serious adverse events, and the treatment-emergent adverse events were mainly ocular events commonly seen after cataract surgery.   Adverse events of IOP elevation were infrequent and were managed easily without the need to stop the study drug.

 There was no difference between APP13007 and placebo in corneal endothelial cell density prior to treatment or at 3 months following treatment.