New Vision-Related Side Effects Warnings For Beovu Eye Injections Have Been Added In US, Australia, And Switzerland, Thus Far
In this recent article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020", we pointed out that the HAWK & HARRIER clinical trials were a significant factor leading to the new warnings for Beovu eye injections about retinal vasculitis and retinal vascular occlusion. Now we want to take a closer look at the Novartis internal review of Bevou vision-related side effect cases observed in the HAWK & HARRIER clinical trials, including rare post-marketing safety reports of vasculitis.
We begin with this June 9, 2020 news report, "Review committee confirms safety signal of rare adverse events for Beovu", from which we get these insights:
Novartis received reports of vasculitis in 14 patients treated for wet age-related macular degeneration with Beovu (brolucizumab-dbll) since its approval by the FDA in October 2019. The company initiated an internal review of the case reports and established an external safety review committee (SRC) to provide an independent review of the cases....
The SRC compared the reported cases with events seen in the [Beovu] phase 3 HAWK and HARRIER trials. Using terminology defined by the SRC, Novartis confirmed a safety signal of rare adverse events termed as “retinal vasculitis” and/or “retinal vascular occlusion,” which typically occurred in the presence of intraocular inflammation. The adverse events may lead to severe vision loss...
An unmasked review was conducted by the SRC on a subset of imaging data from the trials, which found some of the same adverse events. They occurred on a spectrum ranging from intraocular inflammation to vasculitis to occlusive events, sometimes resulting in vision loss.
According to post-marketing data, retinal vasculitis, retinal vascular occlusion or retinal vasculitis plus retinal vascular occlusion were evident in every 6.99 per 10,000 injections. Retinal vasculitis was evident in 1.69 per 10,000 injections, retinal vascular occlusion was evident in 1.57 per 10,000 injections, and retinal vasculitis plus retinal vascular occlusion was evident in 3.73 per 10,000 injections.
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To learn more about the intraocular inflammation and retinal artery occlusive events which were reported in the HAWK & HARRIER trials, you can review this Original Article item, "HAWK and HARRIER: Phase 3, Multicenter, Randomized, Double-Masked Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration", published by the Ophthalmology medical journal in April 2020.
In connection with these post-marketing reports of Beovu vision-loss side effects, on June 9, 2020, the FDA approved a Beovu label change which added warnings about retinal vasculitis and retinal vascular occlusion, which can lead to loss of vision. Following this FDA regulatory action, there have been new Beovu warnings added in Australia and Switzerland, with more drug safety regulatory actions expected in other countries going forward.
The Australian Health Authority (TGA) approved a revised Beovu drug label which now states that retinal vasculitis and/or retinal vascular occlusion have been reported with the Beovu eye injections. Further, there is this additional Bevou safety information:
- Concomitant intraocular inflammation was reported, but not in all Bevou vision-related side effect cases; and,
- Prior intravitreal VEGF inhibitor therapy treatment was not reported for all Bevou vision-related side effect cases, but some patients have such therapy previously.
The Swiss Health Authority (Swissmedic) approved a revised Beovu drug label. It was updated to state that retinal vasculitis and/or retinal vascular occlusion have been reported with Beovu eye injections and that in most Bevou vision-related side effect cases intraocular inflammation was also present.
We are currently investigating drug injury lawsuits against Novartis for Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.
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