The company's proprietary mucus penetrating particle technology dramatically improves drug distribution and pharmacokinetics by uniformly coating the mucosal surface with biocompatible, drug-loaded particles. In addition, the potential for Eysuvis to be used both as a first line prescription medicine and complementary to existing therapies, could result in a preferred profile for the short-term treatment of dry eye disease, including the management of dry eye flares and other dry eye associated conditions. La première tranche de 75 millions de dollars est déjà à la banque, tandis que les 35 millions restants sont payables à certaines étapes clés du pipeline de la société. Consistent with prior clinical experience, Eysuvis was well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the January 2019 launch of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product candidate, Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25%, for which a New Drug Application (NDA) is under review by the United States Food and Drug Administration (FDA) with a target action date under the Prescription Drug User Fee Act (PDUFA) set for October 30, 2020. “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. Click on the different category headings to find out more and change our default settings. These flares can be caused by a wide variety of triggers and often cannot be adequately managed with current therapies. “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. 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. Kala believes that the broad mechanism of action of Eysuvis, rapid onset of relief of both signs and symptoms and favorable tolerability and safety profile combine for a strong profile to treat Dry Eye Disease. By using our website without changing your cookie settings you agree to our use of cookies as described in our Privacy Statement. Wir und unsere Partner nutzen Cookies und ähnliche Technik, um Daten auf Ihrem Gerät zu speichern und/oder darauf zuzugreifen, für folgende Zwecke: um personalisierte Werbung und Inhalte zu zeigen, zur Messung von Anzeigen und Inhalten, um mehr über die Zielgruppe zu erfahren sowie für die Entwicklung von Produkten. Kala is a Biopharmaceutical Company Committed To Advancing the treatment of eye diseases . Für nähere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklärung und Cookie-Richtlinie. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Additionally, a live webcast and subsequent archived recording of the presentation will be available under “Events” in the “Investors” section of the Kala website at http://kalarx.com. 2020, Terms of Use program. Kala has completed one Phase 2 and three Phase 3 clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3 (STRIDE - Short Term Relief In Dry Eye) for EYSUVIS. This website uses cookies. Eysuvis utilizes Kala's AMPPLIFY™ mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissues of the eye. The information does not usually directly identify you, but it can give you a more personalized web experience. Information. inveltys.com. The small-cap pharma wields an intriguing technology pipeline. Kala Pharmaceuticals, Inc. (NASDAQ: KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today 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 … This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties, including statements regarding the Company's lead product candidate, EYSUVIS, for the short-term relief of the signs and symptoms of dry eye disease.


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