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23.08.2018 20:26:35

FDA Approves Kala's Ocular Surgery Product

(RTTNews) - Kala Pharmaceuticals Inc. (KALA), Thursday said the U.S. Food and Drug Administration has approved Inveltys for the treatment of post-operative inflammation and pain following ocular surgery.

Inveltys is the first twice-daily ocular corticosteroid approved for this indication. Other options available are approved to use for four times a day.

"The FDA approval of INVELTYS is a tremendous milestone for Kala," said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. "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. We believe INVELTYS will be an important addition to eye care professionals' treatment armamentarium."

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.

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