Formosa Pharmaceuticals, Inc. and AimMax Therapeutics, Inc. announced the submission of a New Drug Application to the United States Food & Drug Administration (US FDA) for APP13007, a novel aqueous nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), for the treatment of inflammation and pain following ocular surgery. This proprietary homogeneous nanosuspension has a solution-like appearance which offers great comfort to the eyes and enhanced drug penetration into ocular tissues. APP13007 was evaluated in two pivotal Phase 3 trials in more than 60 sites across the United States.

Both trials were randomized, double-masked studies comparing APP13007 to its matching placebo in nearly 750 subjects following cataract surgery, and included 151 subjects in a corneal endothelial cell safety substudy. Treatment with one drop, twice daily for 14 days met the primary endpoints by producing rapid and sustained clearance of ocular inflammation and relief of ocular pain which were statistically and clinically superior to placebo (p<0.001). APP13007 was well-tolerated with a safety profile similar to that of placebo.