Kala's eye inflammation candidate headed for NDA

Kala Pharmaceuticals Inc. (Waltham, Mass.) said a 1% formulation of KPI-121 loteprednol etabonate mucosal penetrating particle met the co-primary endpoints in a confirmatory Phase III trial to treat pain and ocular inflammation following cataract surgery. The company intends to submit an NDA to FDA in late 2017 in the indication.

Compared to placebo, KPI-121 led to a greater proportion of patients with complete resolution of anterior chamber cells (p=0.01) and complete resolution of ocular pain (p<0.0001) at day 8. Kala said KPI-121 also met the study's secondary endpoints...