Numerous Case Reports of Occlusive Retinal Vasculitis and Vision Loss in Patients Following Beovu Injections
(Posted by Tom Lamb at DrugInjuryWatch.com)
As early as May 2020 it was suggested by the authors of an Editorial piece published online by the American Journal of Ophthalmology (AJO) that the use of Beovu injections should be suspended until the underlying cause of Beovu-associated inflammation is discovered. But the sale and use of Beovu continues to date despite numerous case reports of occlusive retinal vasculitis and vision loss in patients following Beovu injections.
Before looking at that Editorial calling for the suspension of Beovu injections, for background, a summary of the Beovu-associated inflammation safety issue is presented in this July 2020 Journal of VitreoRetinal Diseases Research Article, "Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab". From the Abstract for this item we get these details about the current Beovu safety issue under investigation:
- Purpose: To analyze a case series of retinal vasculitis reported to the American Society of Retina Specialists (ASRS) following Food and Drug Administration approval of [Beovu (brolucizumab)] for treatment of neovascular age-related macular degeneration.
- Results: Retinal vasculitis was reported in 26 eyes of 25 patients (22 [88%] female) after treatment with [Beovu (brolucizumab)]. Imaging studies were available for 24 of 26 eyes. Most cases (92%) were associated with intraocular inflammation, which presented at a mean of 25 days (range, 3-63 days) after the most recent [Beovu (brolucizumab)] injection. Mean visual acuity (VA) was 20/52 (range, 20/25-4/200) before the adverse event, 20/151 (range, 20/25-hand motion) at presentation of the adverse event, and 20/243 (range, 20/30-light perception) at last follow-up. Twelve eyes (46%) had a greater than 3-line decrease in VA at final follow-up, and 12 eyes (46%) had a final VA of 20/200 or worse. Analysis of retinal imaging identified vasculopathy that involved retinal arteries (91%), retinal veins (79%), and choroidal vessels (48%). Occlusive disease was apparent on imaging in 83% of eyes. Treatment approaches were varied.
- Conclusions: Retinal vasculitis has been identified in a series of eyes following [Beovu (brolucizumab)]. Although a few eyes in this series were asymptomatic or minimally symptomatic, some eyes had significant vision loss. A careful examination for signs of active inflammation prior to [Beovu (brolucizumab)] injection is recommended. Once vasculopathy is suspected, angiographic imaging may help define the spectrum of involvement. Optimal treatment strategies remain unknown.
This Beovu safety issue first became known back in February 2020, as we reported in this earlier article, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".
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In view of the ongoing investigation of this Beovu safety issue, it was suggested in May 2020 by a couple of eye doctors that there should be a suspension of Beovu injections. From the above-mentioned AJO Beovu Editorial -- with its ominous title, "Is This a 737 Max Moment for Brolucizumab?" -- published May 25, 2020 by the American Journal of Ophthalmology:
[Both the American Society of Retina Specialists (ASRS)] and Novartis established committees to investigate this [Beovu (brolucizumab)]-induced inflammation. Novartis has willingly refunded the cost of any previously purchased [Beovu (brolucizumab)] to retina practices. However, [Beovu (brolucizumab)] remains on the market and continues to be used with the cautious approval of both the ASRS and Novartis.
Amid mounting speculation as to the underlying cause of this [Beovu (brolucizumab)]-associated inflammation, we all want the investigations to continue so we can learn the truth behind these adverse events. Whatever is learned from these ongoing investigations will provide invaluable information for anyone developing an agent for injection into the eye. But as this process plays out, it is our view that intravitreal injections of [Beovu (brolucizumab)] should stop. [Beovu (brolucizumab)] is not the only drug that can be used for the treatment of [exudative age-related macular degeneration (eAMD)]. In the face of the known risk, its use is unwarranted.
Since this Beovu safety issue was discovered Novartis has added information to the Beovu Prescribing Information, or drug label, that Beovu use can increase the risks of retinal vasculitis and retinal vascular occlusion, which can lead to blindness. We reported that development in this earlier article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020".
We continue to monitor the medical and regulatory realms for significant developments, as well as watch for any information released by Novartis about the findings of their panel of experts who are considering this Beovu safety issue.
Further, 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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