Roche's Vabysmo Gets EU Approval To Treat Two Major Causes Of Vision Loss

Swiss drug major Roche (RHHBY) announced Monday that the European Commission approved Vabysmo (faricimab) to treat neovascular or 'wet' age-related macular degeneration or nAMD and visual impairment due to diabetic macular edema or DME.

These retinal conditions are among the major causes of vision loss worldwide, affecting more than 40 million people.

The company noted that Vabysmo, a bispecific antibody, is the only injectable eye medicine approved in Europe with phase III studies supporting treatment at intervals of up to four months for people living with nAMD and DME.

The approval is based on results across four phase III studies in two indications, involving 3,220 patients: TENAYA and LUCERNE in nAMD at year one, and YOSEMITE and RHINE in DME up to two years.

As per the studies, people treated with Vabysmo, given at intervals of up to four months, achieved similar vision gains and anatomical improvements compared to aflibercept given every two months.

Vabysmo is now approved in the European Union and nine other countries around the world, including the US, Japan, and the UK, for people living with nAMD and DME. Submissions to other regulatory authorities are ongoing.

Roche also continues to explore areas where Vabysmo has the potential to deliver additional benefits to patients, including retinal vein occlusion.

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