In a recent meeting of the American Society of Retina Specialists (ASRS), a warning was issued to its members regarding possible adverse effects of Beovu (brolucizumab).
BEOVU is an anti-VEGF medication recently FDA approved for the treatment of wet macular degeneration. The parent company Novartis received FDA approval for the drug in October 2019 for the treatment of wet macular degeneration.
Other anti-VEGF medications currently used to treat wet macular degeneration include:
- Macugen (pegaptanib)
- Avastin (bevacizumab)
- Lucentis (ranibizumab)
- Eylea (aflibercept)
The efficacy of Beovu has been comparable to Eylea, another anti-VEGF medication also used to treat wet macular degeneration. Other anti-VEGF medications include Avastin and Lucentis. Though the dosing and use of these drugs varies among retina specialists, most of these injections need to be repeated every 4-6 weeks and often for a year or longer.
Unlike other antiVEGF medications, Beovu has the potential to be used with an extended 3 month dosing schedule, thus potentially reducing the number of visits to the doctor’s office.
Letter of Warning
In the letter addressed to its members, the ASRS noted possible side effects not previously observed in clinical trial data.
14 cases of an unusual type of retinal vasculitis (inflammation) following injection of Beovu have been reported since the drug gained FDA approval. In 11 of these patients, severe vision loss was sustained.
Retinal vasculitis is not a known side effect of Eylea, another anti-VEGF medication also used for the treatment of wet macular degeneration. In the FDA trials, the safety and efficacy of Beovu was directly compared to Eylea.
Retinal vasculitis is not a common condition. There is no common denominator between the 14 patients.
Novartis maintains that Beovu is safe and stands behind the safety and efficacy data submitted to the FDA before receiving approval in October. In addition, they are engaging an external safety committee to review these cases of occlusive vasculitis reported since receiving FDA approval.