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Tuesday / May 21.
HomeminewsUS FDA Approves Faricimab for RVO

US FDA Approves Faricimab for RVO

The United States Food and Drug Administration (FDA) has approved Vabysmo (faricimab, Roche) for the treatment of macular oedema following retinal vein occlusion (RVO).

RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).1 Together, the three retinal conditions affect around 70 million people worldwide and are among the leading causes of vision loss.2-5

The first bispecific antibody approved for the eye, Vabysmo targets and inhibits two signalling pathways by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

In further news, Roche will discontinue development of vicasinabin, an oral drug candidate that was being evaluated for nonproliferative diabetic retinopathy.

The decision follows a Phase 2 trial into the designated CB2 agonist, also known as RG7774. As an oral treatment, it was hoped that vicasinabin would lessen the treatment burden of currently administered injection therapy.

The randomised, double-blind study evaluated the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy in 104 participants with moderately severe to severe NPDR and good vision.

Earlier this year, Kodiak Sciences discontinued tarcocimab, a drug that was not as successful in DMO trials. One-year primary endpoint data from another Kodiak Phase 3 trial in non-proliferative diabetic retinopathy, dubbed GLOW, data from the trial is set to be released in Q4 2023.

References avaialable at mivision.com.au