Current Findings On Risks Of Occlusive Vasculitis And Vision Loss Following Beovu Injections For Treatment Of Wet AMD
According to news reports, Beovu safety issues were a dominant topic at the American Society of Retina Specialists (ASRS) annual meeting which was held virtually July 24-26, 2020. In particular, the ASRS Research and Safety in Therapeutics (ReST) committee discussed possible Beovu side effects such as occlusive vasculitis and vision loss following Beovu injections for treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).
We get the following observations made by Paul Hahn, MD, PhD -- who moderated a panel on drug safety at the July 2020 ASRS annual meeting -- from this July 26, 2020, Ocular Surgery News article, "ASRS, Novartis independent committees review safety, risks of Beovu":
As the ReST committee undertook analysis of reports about Beovu, so, too, did Novartis initiate an independent safety review committee.
“To Novartis’ credit, [it] was empowered to function autonomous to Novartis oversight regardless of those findings,” Hahn said.
The Novartis safety review committee identified a rate of 4.6% of [intraocular inflammation (IOI)] of all types.
“Of that, there was a subgroup of patients who developed occlusive vasculitis, in 2.1% of patients,” Hahn said.
In terms of risk, 1 in 200 represents the overall risk of any patient beginning [Beovu (brolucizumab)] therapy losing six or more lines of vision due to occlusive vasculitis.
“Alternatively, if you have a patient who presents to your office having occlusive vasculitis following recent Beovu, that patient has a 1 in 5 risk of at least six-line vision loss,” Hahn said.
The Novartis safety review committee also reported that IOI can occur 12 to 18 months after initiation of treatment. Vision loss can be seen out to 6 to 12 months, but more typically occurs in the first 6 months, Hahn said.
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We have been closely following developments concerning Beovu safety issues for several months now, as seen by these past Drug Injury Watch articles:
- Beovu Safety Signal Found By External Review Committee Which Evaluated Beovu Post-Marketing Adverse Events (July 1, 2020)
- Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020 (June 17, 2020)
- Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report (April 9, 2020)
- Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings (March 4, 2020)
- Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug (February 27, 2020)
Our law firm has heard from individual patients about cases of Beovu injections causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation. These cases are being investigated as potential drug injury lawsuits against Novartis Pharmaceuticals Corporation, the drug company responsible for Beovu here in the US.
Be assured that we will continue to watch for developments concerning possible Beovu side effects in the regulatory, medical, and legal realms.
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