Angioid Streaks

All html pdf doc xls ppt match recent 10 20 30 none small medium large Home About Chugai News Chugai Files in Japan for Additional Indication of Vabysmo for Angioid Streaks, a Leading Cause of Vision Loss The filing is based on the results from a Japanese phase III study for angioid streaks associated with neovascularization, a rare disease with a poor prognosis The application will be reviewed under priority review in Japan If approved, Vabysmo will be the first product for angioid streaks in Japan TOKYO, September 6, 2024 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed for an additional indication with the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)] (Hereafter Vabysmo), for the treatment of angioid streaks associated with neovascularization. For this indication, Vabysmo received orphan drug designation from the MHLW, and the applications will be reviewed under priority review. “Angioid streaks is a rare disease with no approved products in Japan. We will continue to work for approval as soon as possible so that Vabysmo, which demonstrated vision improvement in a Japanese phase III study, can contribute to the treatment of patients as a new option for angioid streaks,” said Chugai’s President and CEO, Dr. Osamu Okuda. This application is based on the results of a Japanese phase III study, the NIHONBASHI study for angioid streaks associated with neovascularization. [Reference] ・NIHONBASHI study Positive Phase III Results Showed Vabysmo Improved Vision for the First Time in Japanese in Angioid Streaks (Press release by Chugai issued on April 15, 2024) https://www.chugai-pharm.co.jp/english/news/detail/20240415113000_1064.html About angioid streaks Angioid streaks is a disease characterized by cracks in parts of the retina, causing-discoloration (pigmented streak) of the fundus. The disease is often asymptomatic, and when choroidal neovascularization extends to the macula region of the fundus, it causes symptoms such as decreased or distorted vision. People with neovascularization have a poor prognosis, but conventional treatments such as surgery and laser are not sufficiently effective, and new treatment options are needed. The number of patients with angioid streaks in Japan is unknown, but approximately 300 patients have pseudoxanthoma elasticum (one of the designated intractable diseases), which is known to be associated with angioid streaks in approximately half of patients.1,2 About NIHONBASHI study NIHONBASHI study is a multicenter, single-arm phase III study in Japan evaluating the efficacy and safety of Vabysmo for the people with angioid streaks associated with neovascularization. 24 people were enrolled into this study. The primary endpoint is the change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at 12 weeks. Secondary endpoints include the mean change in BCVA score at 52 weeks, change in central subfield thickness from baseline over time, and safety. About Vabysmo Vabysmo is the first bispecific antibody approved for the eye. 3,4 It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGFA, Vabysmo is designed to stabilize blood vessels. 4,5 Vabysmo is approved in nearly 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in several countries, including the US, EU and Japan, for the treatment of macular edema following retinal vein occlusion. Review by other health authorities is ongoing. 3,6 Trademarks used or mentioned in this release are protected by law. Sources Chatziralli I, Saitakis G, Dimitriou E, Chatzirallis A, Stoungioti S, Theodossiadis G, et al. ANGIOID STREAKS: A Comprehensive Review From Pathophysiology to Treatment. Retina. 2019;39(1):1-11. Japan Intractable Diseases Information Center. Pseudoxanthoma elasticum (designated intractable disease 166) [Internet; cited September 2024]. Available from: https://www.nanbyou.or.jp/. (Japanese only) United States Food and Drug Administration (U.S. FDA). Highlights of prescribing information, Vabysmo. 2022 [Internet; cited September 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf. Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, Phase III, non-inferiority trials. The Lancet. 2022; 399:729-40. Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, Phase III trials. The Lancet. 2022; 399:741-755. Roche data on file. [PDF 252KB] Contact: For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Hideki Sato Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Back Home About Chugai News Chugai Files in Japan for Additional Indication of Vabysmo for Angioid Streaks, a Leading Cause of Vision Loss About Chugai Message from the CEO Chugai’s Five Strengths Company Outline Our Vision Our Strategy History of Chugai Pharmaceutical Chugai Group R&D Digital Transformation "CHUGAI DIGITAL" Videos & Advertisements Press Room News Media Conference Partnering To our suppliers Investor Relations Management Policy Financial Results Reports & Downloads Shareholder Information Corporate Governance ESG at Chugai Main Products / Development Pipeline See how Chugai compares to other companies Strategic Alliance with Roche Chugai’s Five Strengths Events & Presentations Contacts & Information FAQs Recruitment Chugai Recruiting Site Sustainability Basic Policy (Creation of Shared Value) Sustainability and Business Strategy Sustainable Patient-Centric Healthcare Global Health Human Resources and Diversity & Inclusion Ethics and Compliance Supply Chain Management Human Rights Social Contribution Global Environment Health and Productivity Management Governance External Evaluations Activity Reports Data Chugai's Transparency Guidelines You are now moving to an external website. 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Chugai announced Monday that Vabysmo (faricimab) met the primary endpoint of a Phase III study in Japanese patients with angioid streaks associated with neovascularisation, setting up a filing for expanded use of Roche’s bispecific antibody.The NIHONBASHI study investigated Vabysmo in 24 patients with angioid streaks and neovascularisation. The primary endpoint was the change in the best-corrected visual acuity (BCVA) score at 12 weeks, while secondary goals included BCVA score change at 52 weeks, changes in the central subfield thickness over time, and safety.The company noted that Vabysmo-treated participants had statistically significant and clinically meaningful improvements in vision at 12 weeks. In terms of safety, the drug was well tolerated with no new signals identified. Detailed data will be unveiled at an upcoming conference.“I am very pleased that Vabysmo demonstrates good vision improvement for the first time in Japanese [patients with]...angioid streaks, a rare disease with no approved drugs in Japan,” remarked Chugai CEO Osamu Okuda.The bispecific, which targets pathways involving Ang-2 and VEGF-A, is currently approved for treating neovascular macular degeneration and diabetic macular oedema in over 90 countries, including the US and EU. It was also authorised for the treatment of retinal vein occlusion by the FDA in October, and subsequently in Japan last month. Vabysmo racked up more than $2 billion in annual sales for Roche last year, positioning the prouct at number seven in the top 10 fastest-growing drugs in 2023 (for more, see Spotlight On: Pharma’s fastest-growing drugs in 2023).

[04-October-2023] Ontario and New Brunswick among latest jurisdictions to reimburse biosimilar of anti-VEGF ranibizumab, improving patient access to treatment for certain retinal diseases TORONTO, Oct. 4, 2023 /CNW/ - Biogen Canada Inc. is pleased to announce that Ontario, New Brunswick, and Prince Edward Island have joined Quebec to reimburse PrBYOOVIZ™ (ranibizumab injection), an anti-vascular endothelial growth factor (anti-VEGF) biosimilar therapy for certain eye conditions affecting the retina. In addition, BYOOVIZ is now covered by the Non-Insured Health Benefits (NIHB) and Veterans Affairs Canada (VAC) Health Care Benefits programs. BYOOVIZ is the first biosimilar available in Canada that references PrLUCENTIS® to treat retinal vascular disorders including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema. This provides an additional option for retinal disease management with anti-VEGF therapies, which have become a therapeutic mainstay for various retinal vascular disorders1. With no significant differences in quality, efficacy and safety as their reference biologic drugs, biosimilars offer important, more cost-effective treatment options that can respond to patient needs2. Public reimbursement of biosimilars helps create opportunities for savings and resource reallocation to other areas in the healthcare system. "We're excited to see the expansion of patient access to BYOOVIZ and are very pleased that more jurisdictions are incorporating this additional anti-VEGF option into their publicly administered programs," said Eric Tse, General Manager at Biogen Canada. "We believe this holds great potential for patients, physicians and the healthcare system, and With World Sight Day approaching, are particularly delighted we are able to meet patients' needs with a treatment option that helps make vision care more accessible." The reimbursement criteria for BYOOVIZ for each jurisdiction providing public access through its public drug benefit plan can be found by following the links below: Ontario New Brunswick Prince Edward Island Quebec Non-Insured Health Benefits Program Drug Benefits List Veterans Affairs Canada Treatment Benefits List About BYOOVIZ Administered into the eye by intravitreal injection, BYOOVIZ treats damage to the retina (the light-sensitive back part of the eye) and acts to stop the growth and leakage of new blood vessels in the eye, abnormal processes that contribute to several eye diseases that can cause decreased vision3. BYOOVIZ received marketing authorization from Health Canada in 2022 after meeting quality, efficacy and safety criteria and having demonstrated similar efficacy and a comparable safety pro its reference biologic drug3,4,5. BYOOVIZ is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous choriorentinopathy or idiopathic chorioretinaopathy3. Biogen markets and sells BYOOVIZ pursuant to an agreement with Samsung Bioepis, the marketing authorization holder for the product. The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar candidate referencing EYLEA® (aflibercept). As part of the agreement, Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization. About Biogen Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer's disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology, and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable, and equitable world. To learn more about Biogen Canada, please visit . LUCENTIS® is a registered trademark of Genentech Inc. EYLEA® is a registered trademark of Regeneron Pharmaceuticals SOURCE Biogen Canada