Business
Kala Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update
-- Obtained FDA Approval for EYSUVISTM, First Prescription Therapy Approved Specifically for the Short-Term Treatment of the Signs and Symptoms of Dry Eye
About this update from Kala Bio, Inc.
[{"type":"text","content":"\n-- Obtained FDA Approval for EYSUVISTM, First Prescription Therapy Approved Specifically for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease --\n-- EYSUVIS Expected to Begin Shipping to Wholesalers by End of 2020 --\n-- 3Q 2020 INVELTYS® Net Revenue of $2.2 Million --\n-- Cash Position and INVELTYS Revenue Expected to Provide Runway Into at Least 3Q 2022\nEYSUVIS Revenue Expected to Provide Additional Runway --\n-- Conference Call and Webcast at 8:00 a.m. ET --\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nKala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported financial results for the third quarter ended September 30, 2020 and provided a corporate update.\n\n“We are pleased with our third quarter results and the fourth quarter of 2020 is off to a strong start following the recent FDA approval of EYSUVIS, which we plan to launch by year end as the first prescription therapy specifically designed to address the short-term treatment needs of people living with dry eye disease,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. “EYSUVIS, which is enabled by Kala’s proprietary AMPPLIFY technology, is well-suited to address a significant unmet need for eye care professionals and patients who want an FDA-approved, safe, effective and fast-acting therapy for dry eye disease. We are in a strong financial position to commercialize EYSUVIS along with INVELTYS and we look forward to ensuring that patients and eye care professionals have access to these innovative therapies.”\n\nThird Quarter and Recent Highlights:\n\nEYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25%: On October 26, 2020, the U.S. Food and Drug Administration (FDA) approved EYSUVIS for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (DED). The FDA granted approval for EYSUVIS based on results from four clinical trials that enrolled over 2800 patients and demonstrated rapid and significant improvements in both the signs and symptoms of dry eye disease. EYSUVIS was well-tolerated across the four trials, with adverse events and intraocular pressure increases comparable to that observed with vehicle (placebo).\n\nKala estimates that...