Genentech's Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to Four Months for People With Retinal Vein Occlusion (RVO) in Phase III Trials

Genentech, a member of the Roche Group, has recently announced positive results from the Phase III BALATON and COMINO studies, showcasing the long-term efficacy and safety of Vabysmo® (faricimab-svoa) in treating macular edema caused by branch and central retinal vein occlusion (BRVO and CRVO). These findings mark a significant milestone in the treatment of retinal vein occlusion (RVO), a condition that affects millions of people worldwide.

The studies demonstrated that patients treated with Vabysmo experienced extended treatment intervals of up to four months while maintaining the vision gains achieved in the first 24 weeks of the trials. Moreover, Vabysmo exhibited robust and sustained drying of retinal fluid, as measured by a reduction in central subfield thickness, for up to 72 weeks. This is the first time that such significant vision and anatomical improvements have been maintained for over a year using a personalized treat-and-extend dosing regimen in both global Phase III BRVO and CRVO trials. Importantly, Vabysmo demonstrated a favorable safety profile consistent with previous trials.

Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, expressed enthusiasm about the results, stating, “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. 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.”

If approved by the FDA, Vabysmo would become the first and only treatment targeting and inhibiting two disease pathways associated with various vision-threatening retinal conditions. Currently, Vabysmo is already approved in over 80 countries worldwide for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Adding RVO as a third indication would provide a much-needed treatment option for the millions of individuals affected by these conditions.

Retinal vein occlusion (RVO) affects more than 1 million people in the United States and 28 million people globally. It is the second most common cause of vision loss due to retinal vascular diseases. RVO occurs when the veins in the retina become blocked, leading to sudden and severe vision loss. Vabysmo, with its unique mechanism of action targeting angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), aims to stabilize blood vessels and prevent further damage.

The Phase III BALATON and COMINO studies, which evaluated the efficacy and safety of Vabysmo compared to aflibercept, demonstrated positive results in the first 24 weeks, meeting their primary endpoints of non-inferior vision gains. Additionally, Vabysmo showed rapid and robust drying of retinal fluid during this period. Detailed results from weeks 24 to 72 will be presented at an upcoming medical meeting.

Genentech’s commitment to ophthalmology extends beyond Vabysmo. The company is actively researching and developing new treatments for various eye diseases, including wet AMD, DME, diabetic retinopathy (DR), geographic atrophy (GA), and other retinal conditions. With a strong Phase III clinical development program for Vabysmo and ongoing studies exploring its potential in underrepresented patient populations, Genentech aims to address the unmet needs of individuals living with retinal diseases.

In conclusion, the positive long-term results from the Phase III BALATON and COMINO studies highlight the potential of Vabysmo as a groundbreaking treatment for macular edema due to branch and central retinal vein occlusion. If approved, Vabysmo would provide a much-needed option for patients suffering from RVO, wet AMD, and DME, offering the possibility of preserving vision and reducing the burden of managing these conditions. Genentech’s dedication to advancing ophthalmology treatments underscores their commitment to improving the lives of individuals with retinal diseases.

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