Roche: Vabysmo Gets CHMP Recommendation For Third Indication - Quick Facts

(RTTNews) - Roche (RHHBY) said the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the extension of the Vabysmo marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion. The company expects a final decision from the European Commission in the near future.

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.

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