Loteprednol for pain following ocular surgery

October 10, 2018 0 By CH Unnikrishnan

The US FDA has approved loteprednol etabonate ophthalmic suspension 1%  (Inveltys) for the treatment of post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication.

All other ocular steroids are approved for four-times-a-day dosing. The use of ocular steroids post-surgery is to achieve a rapid reduction of inflammation and to promote healing of the eye. Therefore, ensuring close adherence to the steroid regimen is a critical factor for physicians in the post-surgery care of the patient and eventual overall success of the procedure, Kala Pharmaceuticals, Inc said.

Kala has initiated a third Phase 3 clinical trial, STRIDE 3 (STRIDE – Short Term Relief In Dry Eye), evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.The company expects to report top-line results for STRIDE 3 in the fourth quarter of 2019.

Kala also plans to submit a New Drug Application (NDA) for KPI-121 0.25% during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2,000 patients, including one Phase 2 trial and two Phase 3 efficacy and safety trials (STRIDE 1 and STRIDE 2), the company said.