CHMP recommends approval of Roche's first bispecific eye antibody to treat vision loss

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Swiss pharmaceutical major Roche announced on July 22, 2022, that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its faricimab, marketed under the brand Vabysmo for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).

The company said that it is expecting a final decision regarding the approval of Vabysmo in near future.

Stressing that Neovascular AMD and DME are two leading causes of vision loss, the company said that the currently available therapies require the patients to take eye injections every one or two months, which can be increased to four months with the new drug.

If approved, it would offer the first new mechanism of action in over a decade for people in the EU with these conditions, the statement by Roche further added.

 “Today’s recommendation marks a significant step forward in redefining treatment for people in the EU with nAMD and DME,” Roche’s Chief Medical Officer and Head of Global Product Development Dr Levi Garraway said.

“With the potential to require fewer injections over time while also improving and maintaining vision, Vabysmo could offer a less burdensome treatment schedule for patients, their caregivers, and healthcare systems,” he added.

Referring to trial data, Roche said that the totality of the data across all four studies in nAMD and DME available to date showed that over 60% of people treated with faricimab were able to extend treatment to every four months while improving and maintaining vision.


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