FDA Approves Ocular Post-Operative Treatment for Pain and Inflammation

The Kala Pharmaceuticals therapy INVELTYS becomes the first twice-daily ocular corticosteroid indicated for such treatment.

The US Food and Drug Administration (FDA) has approved loteprednol etabonate ophthalmic suspension 1% (INVELTYS) for the treatment of post-operative inflammation and pain following ocular surgery.

With the approval, the Kala Pharmaceuticals therapy becomes the first twice-daily ocular corticosteroid indicated for such treatment.

Previous ocular steroids indicated for post-operative ocular treatment were approved for four-times-a-day dosing, according to Kala—a dosing regimen that could hinder the reduction of inflammation and healing of the patient eye. Kim Brazzell, PhD, chief medical officer of Kala, noted the approximate 8 million patients undergoing ocular surgeries annually could benefit greatly from the INVELTYS approval.

"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," Brazzell said in a statement. "We believe INVELTYS will be an important addition to eye care professionals’ treatment armamentarium."

Mark Iwicki, chairman, president, and chief executive officer of Kala, said the therapy is anticipated to launch in the beginning of 2019. The company also intends to advance clinical analysis for KPI-121 0.25%, an investigative therapy intended for dry eye disease. A third phase 3 trial for the therapy, Short Term Relief in Dry Eye (STRIDE 3), will evaluate the solution for its capabilities in temporarily relieving dry eye disease signs and symptoms.

Kala intends to report top-line results from STRIDE 3 in the fourth quarter of 2019, and to submit a New Drug Application (NDA) for KPI-121 0.25% during the second half of 2018. The NDA will include data from 3 clinical trials involving approximately 2000 patients, including one phase 2 trial and a pair of phase 3 efficacy and safety trials (STRIDE 1 and STRIDE 2).