Zurich (awp) – Genentech, a US subsidiary of Roche, has obtained approval from the US health authority FDA for the eye drug Faricimab, which will be marketed under the name Vabysmo. This injectable product has been approved for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME), Genentech said overnight from Friday to Saturday.
The FDA accepted the application for approval last July. AMD and DME are two of the most common causes of vision loss in American adults. Approval is based on positive results from four phase III studies in both indications.
Vabysmo is the first and only injectable drug cleared by the FDA for the treatment of both diseases. The injections, spaced one to four months apart during the first year, help preserve or improve sight. In addition, patients may receive fewer injections than current standard treatment, which typically involves one injection every one to two months.
Vabysmo will be marketed in the coming weeks in the United States, Genentech said. The European health authority EMA is also examining the application for approval of the drug.
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