Genentech Reports Positive Topline Results From Vabysmo Trial In Retinal Vein Occlusion

Genentech, a member of Swiss drug major Roche Group (RHHBY), announced Thursday positive topline results from Phase III trials that showed Vabysmo improved vision for people living with Retinal Vein Occlusion or RVO.

Two global Phase III studies, BALATON and COMINO, evaluated the first and only bispecific antibody for the eye, Vabysmo (faricimab-svoa), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).

RVO is a vision-threatening condition that impacts more than 1 million people in the United States.

The company noted that both studies met their primary endpoints, showing that people with macular edema due to BRVO and CRVO receiving Vabysmo injections every four weeks, for up to 24 weeks, achieved non-inferior visual acuity gains compared to those receiving aflibercept injections every four weeks.

Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.

In both studies, Vabysmo was generally well tolerated. The safety profile was consistent with previous trials.

The company plans present detailed results at an upcoming medical meeting and submit the data to regulatory authorities.

To date, Vabysmo is approved in more than 40 countries around the world for people living with wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).

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