The American Society of Retina Specialists sent a note to their members on February 23 alerting them to 14 cases of the sight-threatening condition retinal vasculitis in Beovu (brolucizumab) patients. Novartis responded by engaging “an external safety review committee to further evaluate [the] post-marketing cases,” according to a spokesman.
Novartis then acknowledged that some Beovu patients were experiencing side effects which can lead to vision loss. Novartis found that some Beovu patients were developing retinal artery occlusion, vasculitis or other events involving severe vision loss. Retinal artery occlusion and vasculitis can lead to vision loss. Novartis has provided data which shows that 8.75 to 10.08 Beovu patients per 10,000 injections have experienced these events.
Novartis says that reports have stated these conditions can develop as quickly as after the first or second Beovu injection. The reports have said patients have reported vision changes like floaters or blurred vision within one to two weeks of Beovu treatment.
Novartis’ review of Beovu’s manufacturing process concluded that all Beovu on the market was manufactured correctly, meets all quality attributes and contains levels of toxins below the approved level.
Beovu’s review of post-marketing safety reports concluded that Beovu was associated with “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.”
Novartis has initiated an update to Beovu’s worldwide prescribing information. Novartis is also working on changing its clinical trial protocols to prevent these conditions from occurring in the future.
Age-related macular degeneration (AMD) is a condition of the eye which can result in blurred vision or loss of vision in the center of the visual field. Wet AMD is a particular form of advanced AMD. Wet AMD leads to vision loss caused by abnormal blood vessel growth in the choriocapillaris. These abnormal vessels are fragile and leak blood and proteins. This leaking can cause irreversible damage to photoreceptors and rapid vision loss.
Wet AMD is typically but not always preceded by dry AMD. The designation of dry AMD refers to all forms of AMD which are not neovascular.
Wet AMD can be caused by an excess of VEGF-A protein. VEGF-A protein can cause abnormal blood vessel growth underneath the macula. Beovu is able to treat wet AMD because it is is an inhibitor of VEGF-A. It inhibits VEGF receptor activation by preventing ligand-receptor interaction. This suppresses endothelial cell proliferation and vascular permeability.