Tuesday, April 16, 2024

FDA Grants Approval to Roche’s Vabysmo for Retinal Vein Occlusion Treatment

Similar articles

Roche has received approval from the United States Food and Drug Administration (U.S. FDA) for Vabysmo® (faricimab) to treat macular edema resulting from retinal vein occlusion (RVO). This marks the third approved indication for Vabysmo, in addition to its use in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Vabysmo’s expanded usage aims to address the needs of the many individuals affected by these common retinal conditions that can lead to vision loss. The safety and efficacy of Vabysmo have been demonstrated in a series of clinical trials and are reinforced by an expanding body of real-world evidence, offering a promising therapeutic option for patients.

Vabysmo is the first and only bispecific antibody developed for ocular use. Its approval for the treatment of RVO is primarily based on successful results from two global phase III studies, BALATON and COMINO. These trials found that monthly administration of Vabysmo led to early and sustained vision improvements in individuals with branch and central RVO. Importantly, these improvements were non-inferior to those achieved with aflibercept, a commonly used treatment. Furthermore, Vabysmo was effective in rapidly and robustly drying retinal fluid. The safety profile was consistent with previous clinical trials, and the most common adverse reaction observed was conjunctival hemorrhage (3%). The overall safety results were consistent across all study arms.

The U.S. label for Vabysmo across all its approved indications will now include additional information in the Warnings and Precautions section regarding rare post-marketing cases of retinal vasculitis and/or retinal vascular occlusion. These occurrences have been documented in the presence of intraocular inflammation, with a reporting rate of 0.06 cases per 10,000 injections. This rate aligns with the frequencies of similar events reported in real-world usage of other widely used intravitreal treatments for individuals with nAMD, DME, and RVO.

Vabysmo has received approval in more than 80 countries globally for individuals with nAMD and DME, and approximately 2 million doses have been distributed thus far. Roche’s continued efforts in expanding its indications and ensuring a robust safety profile highlight its dedication to providing effective treatments for a wide range of retinal conditions, addressing the needs of a substantial patient population.

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article