Kala Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, announced that the U.S. Food and Drug Administration (FDA) has approved Inveltys (loteprednol etabonate ophthalmic suspension) 1% 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. Approximately 8 million patients undergo ocular surgeries each year.
“The approval of Inveltys offers patients and their eye care professionals the first and only BID ocular corticosteroid therapy that has been shown in clinical trials to be clinically effective while maintaining a proven safety profile, which may improve compliance and prove less burdensome for patients,” Kim Brazzell, Ph.D., chief medical officer of Kala Pharmaceuticals, said.
All other ocular steroids are only approved for four-times-a-day dosing. This more frequent dosing requirement can lead to issues for both doctors and patients. Corticosteroids are the foundation of therapy for post-ocular surgery care, with the key goal of controlling inflammation and pain which is caused by surgical trauma to the eye.
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 also continues to advance KPI-121 0.25% for dry eye disease. 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).
(Source: Kala Pharmaceuticals, Inc.)
