Beovu was recently cleared by the FDA for the treatment of wet macular degeneration. Warnings about its use were recently issued by the American Society of Retina Specialists (ASRS).
Beovu is yet another anti-VEGF medication and, like the others, is delivered directly into the eye by injection. The drugs usually need to be repeated every 4-6 weeks and for an undetermined period.
At the recent meeting of the American Society of Retina Specialists (ASRS), a warning letter was issued to its retina specialist members that a very unusual side effect has been reported.
14 patients with retinal vasculitis have been reported. 11 of the 14 cases were reported to have occlusive retinal vasculitis resulting in severe vision loss. Retinal vasculitis is an unusual complication of any of the anti-VEGF medications.
Other medications used for the treatment of wet macular degeneration include:
- Macugen (pegaptanib)
- Avastin (bevacizumab)
- Lucentis (ranibizumab)
- Eylea (aflibercept)
Anti-VEGF medications temporarily halt the abnormal growth of neovascularization (abnormal blood vessels) within the layers of the retina. Because the vessels tend to grow back, injections need to be repeated.
Until Beovu was FDA approved, most anti-VEGF injections are repeated every 4-6 weeks. Beovu is unique in that it was approved for a possible 3 month dosing schedule (i.e. an interval of 3 months vs. 4-6 week).
Visual results were comparable to the visual results obtained by Eylea. The drug was not tested against the other anti-VEGF injections in the data submitted for FDA approval.
Novartis Pharmaceuticals is the manufacturer of Beovu and in two public statements stands by the safety and efficacy of the drug as reported to the FDA.
The company states that the 14 cases of vasculitis fall well within the reported incidence of severe vision loss although it is not clear that vasculitis, specifically, was ever reported as a side effect.
The company is moving forward with its own investigation of these “post-marketing” events and is engaging the help of an external Safety Review Committee (SRC).
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