Any claim or cause of action arising out of or related to the Site or the Terms of Use must be filed within one year after such claim or cause of action arose. 1x1 Meetings: Friday, November 19, 2021, Piper Sandler 33rd Annual Healthcare Conference Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. The US Food and Drug Administration has approved Susvimo (ranibizumab) 100mg/mL for intravitreal use… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. We also continued to advance our pipeline. [Image from Genentech] Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD). Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated a patent held by Mati Therapeutics, Inc. (Mati) relating to a drug delivery system containing dexamethasone. While it is early in the fourth quarter, monthly growth in ASC volumes appears to be coming back on track as the Company estimates sales of in-market sales of over 9,600 billable units in October, its second-largest month ever. Ocular inflammation and pain following cataract surgery, Post-surgical ocular inflammation and pain, here to unlock and sign up to a 14-day FREE TRIAL, Ocular Therapeutix™ to Participate at Two Upcoming Investor Conferences, https://www.businesswire.com/news/home/20211115005512/en/. Research and development (R&D) expenses were $56.0 million for the third quarter of 2021, as compared to $29.3 million for the third quarter of 2020. This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines. The failure of any party to exercise or enforce any right or provision of the Terms of Use shall not constitute a waiver of such right or condition. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. The U.S. Commercial Uptake of DEXTENZA. View source version on businesswire.com: https://www.businesswire.com/news/home/20211101005314/en/, Website design & development Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company's product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; the development and regulatory status of the Company's product candidates, such as the Company's development of and prospects for approvability of OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI for the treatment of retinal diseases including wet AMD; the ongoing development of the Company's extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; the potential utility of any of the Company's product candidates; the potential benefits and future operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; potential market sizes for indications targeted by the Company's product candidates, if approved; the expected impact of the COVID-19 pandemic on the Company and its operations; the sufficiency of the Company's cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. CMS further indicated that DEXTENZA is eligible to receive separate payment in the ASC setting because it meets the criteria set forth in the non-opioid as a surgical supply provision, which is favorable for 2023 and beyond. Customer Service For product information, new accounts, payments, orders, and more 1 (800) 377-7790. Wet Age-related Macular Degeneration (AMD). Six poster presentations will be made at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting being held November 12 -15, 2021. An archive of the webcast will be available until February 8, 2022 on the Company's website. The value of this book lies in the quality and expertise of the text chapters contributed by multiple international experts across the globe. Clearly written by the contributors providing a global perspective about the subject. Please see the full Prescribing Information for EYLEA. FDA approves Biktarvy for young children with HIV. The Company continues enrolling subjects in the U.S.-based Phase 1 clinical trial evaluating a single OTX-TKI implant containing a 600µg dose of axitinib plus anti-. The second was Medicare's final rule that determined that DEXTENZA will be paid separately in the hospital outpatient and ASC settings in 2022 and is eligible under the current criteria for separate payment in the ASC as a non-opioid pain management drug beyond 2022, positioning our vibrant business in the surgical setting to grow into the foreseeable future. Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. 8032 0 obj <>/Filter/FlateDecode/ID[<2CC82E111E78C547A014AF86F429A036><78458149D806BD499552FC34433DC427>]/Index[7995 104]/Info 7994 0 R/Length 155/Prev 569324/Root 7996 0 R/Size 8099/Type/XRef/W[1 3 1]>>stream intravitreal use by compounding pharmacies. Presentation: Pre-recorded fireside chat will be made available on-demand beginning on Thursday, November 18th at 8:00 AM GMT / 4:00 AM ET About ReSure Following supportive data from a U.S.-based Phase 1 clinical trial, the Company is targeting the initiation of a randomized, double-masked, active-controlled Phase 2 clinical trial by year end 2021 in the United States. Ocular Therapeutix Inc. The live webcast can be accessed by visiting the Investors section of the Company's website at investors.ocutx.com. PG0495 Intravitreal and Punctum Corticosteroid Implants. This compares to a net loss of $11.9 million, or a loss of $(0.19) per share on a basic and a loss of $(0.21) per share on a diluted basis for the same period in 2020. This book will focus for the first time on how to avoid complications of uveitis, or how to deal with them either surgically or medically. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this press release. Please check the paediatric RAG list for those drugs/indications which are specific to use in children only. This book will serve as an important resource as it contains a number of relevant references highlighted for their importance to the field. It is a treatment option for corneal disease not amenable to standard penetrating keratoplasty (PKP) or corneal transplant. 0 Four Company-sponsored and investigator-initiated presentations were made at the American Academy of Optometry (AAOPT) Annual Meeting 2021 November 3 - 6, 2021. This cash guidance is subject to a number of assumptions including those related to the severity and duration of the COVID-19 pandemic, the revenues, expenses and reimbursement associated with DEXTENZA, and the pace of research and clinical development programs, among other aspects of the business. Received Final Rules for the Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) from the Centers for Medicare and Medicaid (CMS). This decision affirms the judgment made in June 2020 by the Patent Trial and Appeal Board (PTAB) of the…. If any provision of the Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of the Terms and Conditions, which shall remain in full force and effect. Allergic conjunctivitis represents the Company's first indication that will primarily be prescribed by physicians within the office setting and begins to lay the commercial foundation for additional potential pipeline product candidates to be used to treat patients in that setting. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. 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ReSure Sealant is indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults.
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intravitreal injection reimbursement