28.06.2024 13:52:13 - dpa-AFX: Roche: Vabysmo Gets CHMP Recommendation For Third Indication

SOUTH SAN FRANCISCO (dpa-AFX) - 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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