– Vabysmo showed robust and sustained retinal drying up to 72 weeks and a safety profile consistent with previous trials –
– If approved by the FDA, RVO would be Vabysmo’s third indication in addition to wet age-related macular degeneration (AMD) and diabetic macular edema (DME) –
– Vabysmo is the first and only treatment that targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline long-term results from the global Phase III BALATON and COMINO studies evaluating extended treatment intervals with Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).
From weeks 24 to 72, all people in both studies received Vabysmo using a treat-and-extend dosing regimen, which allows tailoring of their treatment interval according to the individual patient’s response to treatment. Data showed people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the trials. Vabysmo continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness. This is the first time that vision and anatomical improvements have been maintained for more than a year using a personalized treat-and-extend dosing regimen in both global Phase III BRVO and CRVO trials. In both studies, Vabysmo was generally well-tolerated and the safety profile was consistent with previous trials.
“These are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition.”
RVO impacts 28 million people globally and more than 1 million people in the United States. If approved by the FDA, RVO would be the third indication for Vabysmo in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Together, the three conditions affect around 3 million people in the U.S. and are among the leading causes of vision loss.
Detailed results from weeks 24 to 72 of the Phase III BALATON and COMINO studies will be presented at an upcoming medical meeting.
Data from the first 24 weeks of the Phase III BALATON and COMINO studies, presented at Angiogenesis, Exudation and Degeneration 2023, demonstrated early and sustained vision improvement with Vabysmo, with both studies meeting their primary endpoints of non-inferior vision gains compared to aflibercept. A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline to week 24, as measured by reduction in central subfield thickness.
Data up to 24 weeks have been submitted to global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency. A decision from the FDA is expected in late 2023.
Vabysmo 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.
To date, Vabysmo is approved in more than 80 countries around the world for people living with wet AMD and DME, including the United States, Japan, the United Kingdom and the European Union, with more than 1.5 million doses distributed globally.
About Retinal Vein Occlusion (RVO)
Retinal 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 “branches” 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’s central retinal vein becomes blocked.
About the BALATON and COMINO Studies
BALATON (NCT04740905) and COMINO (NCT04740931) are two randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo®️ (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, using a treat-and-extend approach.
The BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion.
The primary endpoint of each study was the change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. Secondary endpoints (weeks 0-24) include change in central subfield thickness and drying of retinal fluid, from baseline over time up to week 24. Secondary endpoints (weeks 24-72) were treatment durability at 68 weeks and continuation of weeks 0-24 endpoints.
About the Vabysmo® (faricimab-svoa) Clinical Development Program
Genentech 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, age-related 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 several Phase IV studies, including the ELEVATUM study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo in a subpopulation of wet AMD highly prevalent in Asia, as well as the VOYAGER study, a global real-world data collection platform. Genentech also supports several other independent studies to further understand retinal conditions with a high unmet need.
About Vabysmo® (faricimab-svoa)
Vabysmo (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.
Vabysmo U.S. Indications
Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD) and diabetic macular edema (DME).
Important Safety Information
Vabysmo 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.
Warnings and Precautions
- Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
- Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection.
- Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event.
The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 7%). These are not all the possible side effects of Vabysmo.
Pregnancy, Lactation, Females and Males of Reproductive Potential
- Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo.
- It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo.
Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.
About Genentech in Ophthalmology
Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Shirley Dang, (650) 467-6800
Jenée D. Williams, (650) 303-2958
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