Roche's Vabysmo Recommended by CHMP for Retinal Vein Occlusion

Roche has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorization for Vabysmo® (faricimab) to treat visual impairment due to macular edema secondary to retinal vein occlusion (RVO). The final decision from the European Commission is expected soon.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, expressed optimism about this development, citing the significant impact of retinal vein occlusion on patients' lives. He highlighted the potential of Vabysmo to offer a new treatment option that could help preserve and improve vision.

This recommendation is based on 72-week data from two Phase III studies, BALATON and COMINO, involving over 1,200 participants with macular edema due to branch and central RVO. In these studies, Vabysmo showed early and sustained vision improvements that were non-inferior to aflibercept, alongside robust retinal drying. The safety profile of Vabysmo was consistent with earlier studies, and the treatment was well tolerated.

Currently, available treatments for RVO are typically administered every one to two months. Vabysmo, however, offers a different approach, with patients receiving the treatment up to every four months after the initial period.

Vabysmo is already approved for RVO in the United States and Japan and is authorized for use in over 95 countries for other conditions, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Roche's commitment to ophthalmology is evident in its broad pipeline of retina treatments. The company is dedicated to innovation in science and the development of treatments that can save eyesight. Their extensive research includes ongoing Phase III clinical programs evaluating the long-term safety and tolerability of Vabysmo in conditions like nAMD and DME.

Retinal vein occlusion is a leading cause of vision loss from retinal vascular diseases, impacting around 28 million adults globally, primarily those aged 60 and older. The condition can result in severe and sudden vision loss due to vein blockage, which disrupts normal blood flow in the retina and leads to complications like ischemia, bleeding, fluid leakage, and macular edema.

RVO is classified into two main types: branch RVO, affecting over 23 million people worldwide, and central RVO, which is less common but more severe, affecting over four million people globally. Both types cause sudden, painless vision loss in the affected eye.

The BALATON and COMINO studies were global, multicenter, randomized trials comparing Vabysmo with aflibercept. Participants initially received six monthly injections before moving to a treat-and-extend regimen. The primary endpoint was the change in best-corrected visual acuity at 24 weeks, with secondary endpoints including changes in central subfield thickness and retinal fluid drying over time.

Vabysmo is a bispecific antibody that targets and inhibits Ang-2 and VEGF-A, two signaling pathways involved in several vision-threatening retinal conditions. By neutralizing these pathways, Vabysmo aims to stabilize blood vessels and reduce inflammation and leakage.

Roche continues to explore new treatments and expand its ophthalmology pipeline, focusing on gene therapies and addressing various vision-threatening conditions like diabetic eye diseases, geographic atrophy, and autoimmune conditions, including thyroid eye disease and uveitic macular edema.

The company’s innovative approach has led to significant advances in treating vision loss, with products like Susvimo® and Lucentis® already making a difference in patients' lives. Founded in 1896, Roche remains a leader in biotechnology and diagnostics, committed to improving healthcare through scientific excellence and personalized healthcare approaches.