{"id":50141,"date":"2022-10-27T07:02:06","date_gmt":"2022-10-27T05:02:06","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/positive-topline-phase-iii-results-show-genentechs-vabysmo-improved-vision-for-people-living-with-retinal-vein-occlusion-rvo\/"},"modified":"2022-10-27T07:02:06","modified_gmt":"2022-10-27T05:02:06","slug":"positive-topline-phase-iii-results-show-genentechs-vabysmo-improved-vision-for-people-living-with-retinal-vein-occlusion-rvo","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/positive-topline-phase-iii-results-show-genentechs-vabysmo-improved-vision-for-people-living-with-retinal-vein-occlusion-rvo\/","title":{"rendered":"Positive Topline Phase III Results Show Genentech\u2019s Vabysmo Improved Vision for People Living With Retinal Vein Occlusion (RVO)"},"content":{"rendered":"
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\n\u2012 Vabysmo achieved its primary endpoint of non-inferiority compared to aflibercept in RVO in the BALATON and COMINO clinical trials \u2013<\/i>\n<\/p>\n

\n\u2012 Vabysmo was generally well tolerated, with <\/i>a safety profile consistent with previous trials \u2013<\/i>\n<\/p>\n

\n\u2012 Vabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditions \u2013<\/i>\n<\/p>\n

\n\u2012 Detailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world \u2013<\/i>\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results from two global Phase III studies, BALATON and COMINO, <\/b>evaluating the first and only bispecific antibody for the eye, Vabysmo\u00ae (faricimab-svoa), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). RVO is a vision-threatening condition that impacts more than 1 million people in the United States.\n<\/p>\n

<\/a><\/p>\n

\nBoth studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every four weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every four weeks.\n<\/p>\n

\n\u201cThese encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cToday\u2019s results add to the extensive evidence supporting Vabysmo\u2019s efficacy in treating multiple types of retinal conditions. We look forward to submitting these data to regulatory authorities.\u201d\n<\/p>\n

\nVabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.\n<\/p>\n

\nIn both studies, Vabysmo was generally well tolerated. The safety profile was consistent with previous trials.\n<\/p>\n

\nDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world.\n<\/p>\n

\nVabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. The level of Ang-2 is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.\n<\/p>\n

\nTo date, Vabysmo is approved in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, for people living with wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabysmo\u2019s long-term efficacy and safety in wet AMD and DME has been demonstrated by two-year data from four large, global studies involving more than 3,000 participants. Vabysmo is the only injectable eye medicine approved for wet AMD and DME by the U.S. Food and Drug Administration (FDA) with the option for treatments from one to four months apart in the first year following four initial monthly loading doses, based on evaluation of the patient\u2019s anatomy and vision outcomes. Globally, more than 165,000 Vabysmo doses have been distributed for treatment of these conditions to date. RVO, wet AMD and DME together affect around 3 million people in the United States and are among the leading causes of vision loss.\n<\/p>\n

\nAbout Retinal Vein Occlusion<\/b>\n<\/p>\n

\nRetinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular diseases. It affects more than 1 million people in the U.S., mainly those aged 50 or older, and can lead to severe and sudden vision loss. The level of angiopoietin-2 (Ang-2) is elevated in RVO, and it is thought that increased Ang-2 expression drives disease progression. RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage, and retinal swelling called macular edema. Currently, macular edema due to RVO is typically treated with repeated intravitreal injection of anti-vascular endothelial growth factor therapies. There are two main types of RVO: branch retinal vein occlusion (BRVO), which affects an estimated 887,000 people in the U.S. and occurs when one of the four smaller \u201cbranches\u201d of the main central retinal vein becomes blocked; and central retinal vein occlusion (CRVO), which is less common, affecting an estimated 265,000 people in the U.S., and occurs when the eye\u2019s central retinal vein becomes blocked.\n<\/p>\n

\nAbout the BALATON and COMINO Studies<\/b>\n<\/p>\n

\nBALATON (NCT04740905<\/a>) and COMINO (NCT04740931<\/a>) are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo\u00ae\ufe0f (faricimab-svoa) compared to aflibercept. For the first 20 weeks, patients are randomized 1:1 to receive six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24-72, all patients receive Vabysmo (6.0 mg) up to every four months \u2013 according to a personalized treatment interval dosing regimen \u2013 using a treat-and-extend approach.\n<\/p>\n

\nThe BALATON study is being conducted in 553 people with branch retinal vein occlusion. The COMINO study is being conducted in 729 people with central retinal or hemiretinal vein occlusion.\n<\/p>\n

\nThe primary endpoint of each study is the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. Secondary endpoints include change in central subfield thickness from baseline over time up to week 24.\n<\/p>\n

\nAbout the Vabysmo\u00ae (faricimab-svoa) Clinical Development Program<\/b>\n<\/p>\n

\nGenentech has a robust Phase III clinical development program for Vabysmo. The program includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in wet, or neovascular, macular degeneration (AMD), and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). Genentech has also initiated the Phase IV Elevatum study of Vabysmo in underrepresented patient populations with DME and supports several other independent studies to further understand retinal conditions with a high unmet need.\n<\/p>\n

\nAbout Vabysmo\u00ae (faricimab-svoa)<\/b>\n<\/p>\n

\nVabysmo (faricimab-svoa) is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.\n<\/p>\n

\nVabysmo U.S. Indications<\/b>\n<\/p>\n

\nVabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age\u2011related macular degeneration (AMD) and diabetic macular edema (DME).\n<\/p>\n

\nImportant Safety Information<\/b>\n<\/p>\n

\nContraindications<\/b>\n<\/p>\n

\nVabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.\n<\/p>\n

\nWarnings and Precautions<\/b>\n<\/p>\n