In late May 2021, the latest study data concerning Beovu safety issues resulted in Novartis stopping three key clinical trials — MERLIN, RAPTOR, and RAVEN — as well as Novartis indicating there will be another Beovu label change.
To see how Novartis is seeking to present the current status of its lingering Beovu safety issues as well as the next Beovu label change take a look at their May 28, 2021, Media Release item, “Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program“, which includes this statement:
Novartis has proactively communicated these data to health authorities and will pursue an update to the Beovu prescribing information globally.
We are watching for this forecasted Beovu label change which will, presumably, add new and updated warnings about Beovu vision loss side effects.
For a more in-depth view of this latest development as regards Beovu safety issues, we turn to this June 1, 2021, FiercePharma news report, “Novartis calls off 3 Beovu trials testing more frequent dosing on concerns of vision-threatening side effect”:
[In the MERLIN clinical trial] Beovu doubled the rate of intraocular inflammation compared with [Eylea], with 9.3% percent of patients suffering the complication in the Beovu trial arm. That compared with 4.5% for Eylea. None of the Eylea patients developed reginal vasculitis or retinal vascular occlusion, while those side effects happened in 0.8% and 2% of Beovu patients, respectively. The problem could potentially damage a person’s vision.
In Merlin, the rate of vision loss from any cause was 4.8% for Beovu patients and 1.7% for Eylea patients….
The company has yet to identify the root cause behind Beovu’s safety problem.
As we have reported previously, Beovu lawsuits for our clients have been filed starting in January 2021, alleging Novartis failed to warn doctors and patients about these Beovu safety issues. Our law firm began investigating drug injury lawsuits against Novartis for Beovu back in February 2020, and we continue to accept Beovu cases that involve vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.[View article at original source]