kala pharmaceuticals pipeline
Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Pipeline; Leadership; Investors; Get in Touch; LET’S TAKE THE LONG VIEW TOGETHER. Kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions. The FDA granted approval to EYSUVIS based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease. Dies geschieht in Ihren Datenschutzeinstellungen. Für nähere Informationen zur Nutzung Ihrer Daten lesen Sie bitte unsere Datenschutzerklärung und Cookie-Richtlinie. Kala will hold a conference call today at 8:30 a.m. Phase 3. Select one or more newsletters to continue. The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review of the NDA. Visit. ©2020 Kala Pharmaceuticals      All rights reserved. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Accessibility Policy. Please review our Privacy Statement. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of various risks and uncertainties including, but not limited to: the impact of extraordinary external events, such as the current pandemic health event resulting from the novel coronavirus (COVID-19), and their collateral consequences, including disruption of the activities of our sales force and the market for INVELTYS and any delay in timing of regulatory review of the NDA for EYSUVIS; whether the Company will be able to successfully implement its commercialization plans for INVELTYS and EYSUVIS, if approved; whether the market opportunity for INVELTYS and EYSUVIS is consistent with the Company’s expectations and market research; whether any additional clinical trials will be initiated or required for EYSUVIS prior to approval of the NDA, or at all, and whether the NDA for EYSUVIS will be approved on the timeline expected, or at all; the Company’s ability execute on the commercial launch of EYSUVIS, if and when approved, on the timeline expected, or at all; whether the Company will be able to generate its projected net product revenue on the timeline expected, or at all; whether the Company's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company's expected timeline; other matters that could affect the availability or commercial potential of INVELTYS and the Company's product candidates, including EYSUVIS; and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings the Company makes with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Kala Pharmaceuticals is developing novel treatments for diseases that affect mucosal tissues. EYSUVIS was well-tolerated across the four trials, with adverse events and intraocular pressure increases comparable to that observed with vehicle. Kala believes that EYSUVIS' broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, offer a differentiated product profile for the management of dry eye flares. Accessibility Policy. Pipeline; Clinical Trials; More ; Eysuvis Treatment for Dry Eye Disease Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for Eysuvis for Dry Eye Disease. Dazu gehört der Widerspruch gegen die Verarbeitung Ihrer Daten durch Partner für deren berechtigte Interessen. Kala Pharmaceuticals on the go with upcoming PDUFA. Kala Pharmaceuticals recently announced it will receive up to $110 million in debt financing from Athyrium Capital Management, LP. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Consistent with prior clinical experience, Eysuvis was well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. We also share information about your use of our site with analytics partners. EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. To access the conference call, please dial (866) 300-4091 (domestic callers) or (703) 736-7433 (international callers) five minutes prior to the start of the call and provide the conference ID: 2835104. Yahoo ist Teil von Verizon Media. As announced in March 2020, STRIDE 3, a Phase 3 clinical trial of Eysuvis, met both of its primary symptom endpoints, demonstrating a statistically significant improvement in ocular discomfort severity in both the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline. 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. program. AMPPLIFY is a trademark and INVELTYS is a registered trademark of Kala Pharmaceuticals.US-EYS-2000032      January All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Expected Milestones Planned Next Steps. All information these cookies collect is aggregated and therefore anonymous. 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. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Kala is developing Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease. Because we respect your right to privacy, you can choose not to allow some types of cookies. 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. The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. 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. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Approximately 80 percent of people living with dry eye disease suffer from episodic flares. Kaléo has an active pipeline in various stages of development across a range of therapeutic areas. You can set your browser to block or alert you about these cookies, but then some parts of the site will not work. var path = 'hr' + 'ef' + '='; This information might be about you, your preferences, or your device and is mostly used to make the site work as you expect it to. //-->. I am excited by the approval of EYSUVIS and confident that having access to an approved corticosteroid specifically for dry eye disease will meaningfully impact the management of patients across the U.S.”. 2020, Terms of Use WATERTOWN, MA, USA I October 27, 2020 I 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 … “The FDA’s acceptance of our NDA resubmission signifies critical progress toward our goal of delivering Eysuvis as the first prescription medicine for the short-term treatment of dry eye disease,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. WATERTOWN, Mass.--(BUSINESS WIRE)--May 26, 2020-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for …


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