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Roche : CHMP Recommends Approval Of Vabysmo For Neovascular AMD And DME

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vabysmo or faricimab for the treatment of neovascular or "wet" age-related macular degeneration or nAMD and visual impairment due to diabetic macular edema or DME, Roche (RHHBY) said in a statement.

A final decision regarding the approval of Vabysmo is expected from the European Commission in the near future.

Neovascular AMD and diabetic macular edema are two leading causes of vision loss. The current standards of care typically require eye injections every one to two months. Vabysmo has the potential to extend the time between eye injections to up to four months while improving and maintaining vision.

The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years. The studies showed that people treated with Vabysmo at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months.

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

Vabysmo is already approved in several countries around the world including the US, Japan and the UK for people with nAMD and DME.

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