Business
Kala Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Corporate Update
-- EYSUVIS™ NDA Accepted by FDA; Assigned PDUFA Goal Date of October 30, 2020 -- -- 2Q 2020 INVELTYS® Revenue of $0.8 Million -- -- Conference Call and
About this update from Kala Bio, Inc.
[{"type":"text","content":"\n-- EYSUVIS™ NDA Accepted by FDA; Assigned PDUFA Goal Date of October 30, 2020 --\n-- 2Q 2020 INVELTYS® Revenue of $0.8 Million --\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 second quarter ended June 30, 2020.\n\n\n“We are very pleased with our progress in the second quarter,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. “In May, the FDA accepted our NDA resubmission for EYSUVIS, bringing us closer to potentially delivering the first prescription medicine for the short-term treatment of dry eye disease, including dry eye flares, which affects approximately 33 million people in the United States. We have now turned our attention toward a potential U.S. launch before year-end. Given our established relationships with eye care professionals across the United States and our experience with INVELTYS, we believe we are well-positioned for a successful launch of EYSUVIS, if approved.”\n\n\nSecond Quarter and Recent Highlights:\n\n\nEYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: In May 2020, Kala announced that the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) resubmission for EYSUVIS. The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its six-month review of the NDA.\n\n\nIf approved, Kala intends to commercialize EYSUVIS in the United States with its specialty sales force, which it plans to increase, pending the status of the COVID-19 pandemic, to a total of approximately 100 to 125 sales representatives, who will promote both EYSUVIS and INVELTYS.\n\n\nINVELTYS® (loteprednol etabonate ophthalmic suspension) 1%: In the second quarter of 2020, cataract procedures were down 50% compared to the second quarter of 2019, due to the deferral of ocular surgeries as a result of the COVID-19 pandemic.\n\n\nSimilarly, approximately 21,000 INVELTYS prescriptions were reported by Sym...