Formosa Pharmaceuticals, Inc. (6838.TWO) report a summary of integrated clinical results for APP13007, a novel ophthalmic nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain after cataract surgery. 

Included in the summary results are Phase 2 clinical trials (CPN-201) and two parallel Phase 3 clinical trials (CPN-301 and CPN-302) for APP13007.  All three trials were randomized, double-masked trials in the United States that evaluated APP13007 versus matching placebo (~1:1 ratio) in a total of nearly 900 subjects following cataract surgery.  Primary endpoints included 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.  Across all trials, treatment with an APP13007 eyedrop twice daily for 14 days consistently achieved both primary endpoints by producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were statistically and clinically superior to placebo.  In the ITT population for both Phase 3 trials, a total of 58.2% of subjects had ACC count = 0 on POD15 following APP13007 treatment as compared to 17.3% following placebo treatment.  For sustained clearance of inflammation, 26.5% of subjects had no inflammation cells (ACC count = 0) from POD8 through POD15 following APP13007 treatment as compared to 6.8% following placebo treatment.  A total of 81.4% of subjects on APP13007 were ocular pain free as early as at POD4 as compared to 47.4% on placebo (p<0.001).  For sustained ocular pain grade, 71.6% of subjects had no pain (Pain Grade = 0) from POD4 through POD15 following APP13007 treatment as compared to 27.7% following placebo treatment.  All data were statistically significant with p value < 0.001. APP13007 treatment was well tolerated with a safety profile similar to that of placebo.

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