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Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, today 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.

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.

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.

“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. 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, said Terry Kim, M.D., Professor of Ophthalmology and Chief, Cornea and External Disease Division, Duke University Eye Center.

“On behalf of the Kala team, I want to thank the many patients and clinicians who participated in our clinical trials. With this approval, our ongoing commercialization preparations now advance to the next phase where we plan to hire a specialty sales force that will focus on eye care professionals in the United States. We expect to launch Inveltys in the beginning of 2019, said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals.


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