-- Announced Positive Results from STRIDE 3 Clinical Trial of EYSUVIS in March 2020, Demonstrating Statistically Significant Results for Primary and Key Secondary Endpoints --
-- EYSUVISTM NDA Resubmitted on April 30th; Potential Approval and Launch Before Year-End --
-- Raised $146.9 Million in Gross Proceeds from Sales of Common Stock in Early 2020 --
-- 1Q 2020 INVELTYS® Revenue of $1.1 Million --
-- Conference Call and Webcast at 8:00 a.m. ET –
WATERTOWN, Mass.--(BUSINESS WIRE)--
Kala 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 first quarter ended March 31, 2020.
“The first quarter of 2020 was marked by substantial progress across our business, even as we contended with the uncertainties and unprecedented disruptions imposed by the COVID-19 pandemic,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. “In March, we announced positive results from our STRIDE 3 clinical trial of EYSUVIS, demonstrating statistically significant improvements in both the signs and symptoms of dry eye disease. These results replicated the positive results from prior trials, which highlight the potential of EYSUVIS to be the first prescription medicine for the short-term treatment of dry eye disease, including dry eye flares. As we announced earlier this week, we have resubmitted the NDA for EYSUVIS to the FDA incorporating the positive results from STRIDE 3 and are preparing for a potential approval and launch by year-end.”
COVID-19-related restrictions on elective procedures, which include most ocular surgeries, have affected INVELTYS® prescriptions and revenue, and the impacts are expected to persist through the pandemic. Kala is continuing to support INVELTYS and is preparing for a potential EYSUVIS launch in the second half of 2020. Kala’s sales force is utilizing virtual technologies to remain in contact with prescribers and, based on its interactions with eye care professionals across the United States, Kala expects that many deferred ocular surgeries will be rescheduled once conditions permit. Kala remains well-capitalized following its public offering of common stock in March 2020 and anticipates that its existing cash resources will enable it to fund its operations into at least the second quarter of 2022.
First Quarter and Recent Highlights:
EYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: In March 2020, Kala announced positive topline results from STRIDE 3, a Phase 3 clinical trial evaluating EYSUVIS for the treatment of dry eye disease. STRIDE 3 met both of its primary efficacy endpoints, demonstrating a statistically significant improvement in the symptom endpoint of ocular discomfort severity at day 15 in the overall intent-to-treat (ITT) population and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline. Statistical significance was also achieved in conjunctival hyperemia at day 15 in the ITT population (p