Kala Pharma wins FDA nod for twice-daily ocular corticosteroid

The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication, according to the Waltham, Mass. company.

While corticosteroids are used following ocular surgery to control inflammation and pain, physicians prescribe ocular steroids to achieve a rapid reduction of inflammation and to promote healing. All other ocular steroids are only approved for four-times-a-day dosing.

“The FDA approval of Inveltys is a tremendous milestone for Kala,” said Kim Brazzell, Kala’s chief medical officer, in a prepared statement. “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.”

“Today’s approval of Inveltys is welcome news for the eye care community as it provides a clear advancement in the treatment for inflammation and pain following ocular surgery,” said Dr. Terry Kim, chief of the cornea and external disease division at  Duke University Eye Center. “Having access to a BID corticosteroid in a novel nanoparticle formulation with proven safety and efficacy will make a positive impact on the management of my post-operative patients.”

Kala expects to launch Inveltys in early 2019 and plans to hire a specialty sales force for the drug in the U.S.

Kala has also begun a third Phase III clinical trial, Stride 3, for its dry-eye disease drug, KPI-121 . The company changed the design of Stride 3 after revealing mixed results from two Phase III trials in January.

The company expects to report top-line results for Stride 3 in the fourth quarter of 2019 and also plans to submit a new drug application for KPI-121 0.25% during the second half of 2018. The application will include data from three clinical trials studying approximately 2,000 patients, including one Phase II trial and two Phase III efficacy and safety trials (Stride 1 and Stride 2).

Kala’s shares dropped 6% yesterday following the Inveltys approval announcement. After closing at 12.51 per share, the stock was trading at 12.57 at midday today.