Kala Pharmaceuticals Announces FDA Approval of Dry Eye Drug

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WATERTOWN, Mass.—Kala Pharmaceuticals (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, announced that the U.S. Food and Drug Administration (FDA) has approved Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. “The FDA approval of Eysuvis as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major accomplishment for Kala and an important moment for patients, who have been waiting for an FDA-approved, safe, effective and fast-acting therapy,” said Mark Iwicki, chairman, president and chief executive officer of Kala Pharmaceuticals.

“As we prepare to launch Eysuvis, we will leverage our strong foundation of highly experienced ophthalmology marketing, sales and market access professionals with the goal of establishing Eysuvis as the preferred, first-line prescription therapy for dry eye disease. We’d like to thank the many patients and investigators that were involved in the clinical trials that led to this important milestone.”

Kala reported that as of Sept. 30, 2020, it had cash, cash equivalents and short-term investments of $159.1 million. Kala anticipates that its existing cash, cash equivalents and short-term investments, along with sales of Inveltys, will enable it to fund its operations into at least the third quarter of 2022, with additional cash runway expected based on revenues from sales of Eysuvis.