Business
Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results
– Completed Last Patient Last Visit for STRIDE 3 Dry Eye Disease Trial; Topline Results on Track for First Quarter of 2020 – – Achieved Full Year 2019
About this update from Kala Bio, Inc.
[{"type":"text","content":"\n– Completed Last Patient Last Visit for STRIDE 3 Dry Eye Disease Trial; Topline Results on Track for First Quarter of 2020 – \n\n\n– Achieved Full Year 2019 INVELTYS® Revenues of $6.1 Million –\n\n\n– Conference Call and Webcast Today at 8:00 a.m. ET –\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nKala Pharmaceuticals, Inc. (Kala) (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 fourth quarter and full year ended December 31, 2019.\n\n\n“The last patient has now completed their final study visit in the STRIDE 3 Phase 3 trial,” said Mark Iwicki, Chief Executive Officer of Kala. “We are on track to report topline data in this quarter and to resubmit our New Drug Application to the U.S. Food and Drug Administration in the second quarter of 2020. If approved, we believe that EYSUVIS (KPI-121 0.25%), our product candidate for dry eye disease, could become the preferred prescription therapy for dry eye flares, which affects the vast majority of patients with dry eye disease. In 2019, we successfully launched INVELTYS, achieving steady growth in prescriptions and market share, and we continue to build a broad base of prescribing eye care professionals. This reflects the strong demand we are seeing for INVELTYS in the marketplace, as well as the execution of our commercial team. Our field sales, marketing and market access infrastructure has us well-positioned to rapidly launch EYSUVIS later this year, if approved.”\n\n\nFourth Quarter and Recent Highlights:\n\n\nEYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: In February 2020, Kala completed the last patient, last visit in STRIDE 3 (STRIDE – Short Term Relief in Dry Eye), its Phase 3 clinical trial evaluating EYSUVIS for the temporary relief of the signs and symptoms of dry eye disease. Specific modifications were made to the inclusion and exclusion criteria of STRIDE 3 relative to STRIDE 1 and STRIDE 2 to improve the probability of success of the trial. Kala expects the results of this trial to serve as the basis of its response to the complete response letter (CRL) it received in August 2019 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for EYSUVIS. Kala is targeting to r...