News Reports: There Have Been 11 Cases Of Beovu-Associated Occlusive Retinal Vasculitis, Which Can Lead To Blindness
(Posted by Tom Lamb at DrugInjuryWatch.com)
Several late February 2020 news articles report that the American Society of Retina Specialists (ASRS) recently notified eye doctors about the macular degeneration drug Beovu, warning about a retinal vasculitis Beovu side effect. We get the essential information about this emerging Beovu safety issue from a February 25, 2020 article by Vantage reporter Amy Brown, "Safety scare knocks Novartis":
Most worrying was the medical body’s alert about several cases of a dangerous form of eye inflammation called vasculitis; although this was seen in Beovu’s clinical programme, these occurrences appear to confirm that this is a real issue for the product. Retinal vasculitis can lead to blindness and although only 14 cases were reported to the ASRS, 11 were classified as occlusive retinal vasculitis. This happens when the smaller retinal vessels become blocked, and is of even greater concern.
Beovu injections were approved by the FDA in October 2019 to treat wet age-related macular degeneration, a condition that can eventually lead to blindness.
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A Reuters news report, "Novartis Launches Review Into Safety of Eye Drug Beovu", provides additional information about this Beovu safety issue:
Novartis said it was aware of recently reported adverse effects of the drug, adding it "stands behind the safety and efficacy of Beovu."
"In addition to our own internal assessment, we have engaged an external safety review committee (SRC) to further evaluate these post-marketing cases. We will continue to share details as they become available," the company said.
Around 46,000 injections of Beovu have so far been administered, Novartis said. The U.S. Food and Drug Administration was aware of the review, while the company is now informing other health authorities.
"Our clinical development and pharmacovigilance teams are working with healthcare professionals to quickly obtain and evaluate all available information in order to classify these events and identify potential risk factors," Novartis said.
Lastly, here is a February 25, 2020 Endpoints News article by reporter Natalie Grover which dives deeper into this retinal vasculitis Beovu side effect, "Novartis' plans to wrestle Eylea market share take a hit as Beovu is linked to safety concerns":
... Jefferies analysts conducted a search of the three anti-VEGF agents in wet AMD in the FDA Adverse Event Reporting System (AERS) to compare the incidence of vasculitis and two related adverse events — blindness and eye inflammation.
Following Beovu’s launch, there have been 36 serious cases reported to AERS, with 2 cases (6%) of vasculitis, 6 cases (17%) of blindness and 4 cases (11%) of eye inflammation. The analysts then compared those statistics to Eylea’s total reported cases, cases reported in the first year of launch, and cases reported in the same time period to Beovu’s. They found that incidence in patients treated with Beovu was consistently higher than those with Eylea.
In contrast to Beovu, there were no recorded cases of retinal vasculitis in late-stage trials of Eylea. In pivotal studies of [Beovu], intraocular inflammation and blindness were reported in 4% and 1% of patients, respectively.
We will continue to monitor this emerging Beovu safety issue for significant developments, with a focus on the FDA and other drug regulators around the world.
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