09/09/2024
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09/09/2024
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KUWAIT CITY, Sept 09: Roche, represented by Ali Abdulwahab Al Mutawa Commercial Company (AAW) in Kuwait, announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision regarding the approval is expected from the European Commission in the near future.
Roche Chief Medical Officer and Head of Global Product Development said: “This CHMP recommendation represents an important step towards bringing Vabysmo to even more patients living with vision loss worldwide. Recognizing the disruptive impact retinal vein occlusion can have on the everyday lives and independence of these patients, we hope that Vabysmo will offer a new treatment option that can effectively help preserve and improve their vision.”
The CHMP decision is based on full 72-week data from the Phase III BALATON and COMINO studies evaluating Vabysmo in more than 1,200 people with macular edema due to branch and central RVO (BRVO and CRVO).1,2 In both studies, Vabysmo demonstrated early and sustained vision improvements non-inferior to aflibercept, and robust retinal drying. Vabysmo was well tolerated and the safety profile was consistent with previous studies.3 Current available treatments for RVO are typically given every one to two months. 4,5
Vabysmo was first approved for RVO by the United States Food and Drug Administration in October 2023 and later by the Japan Ministry of Health, Labour and Welfare in March 2024.6-8 It is also approved in more than 95 countries around the world for people living with neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).6,8-11
Roche has the broadest retina pipeline in ophthalmology. Led by science and informed by insights from people with eye conditions, Roche is committed to saving people’s eyesight from the leading causes of vision loss through pioneering treatments.
In Kuwait, Vabysmo is provided in Ministry of Health hospitals through Ali Abdulwahab Al Mutawa Commercial Co., the local agent for Roche Pharmaceuticals. The Ministry of Health in Kuwait has granted approval for the use of Vabysmo in treating adults with Diabetic Macular Edema (DME) and Wet Age-Related Macular Degeneration (AMD). Ali Abdulwahab is also currently working with the Ministry of Health to obtain approval for the use of the drug in cases of Retinal Vein Occlusion (RVO).
