And Novartis "has yet to identify the root cause behind Beovu’s safety problem", According to a News Report
(Posted by Tom Lamb at Drug Injury Watch)
Starting back in February 2020, when the American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis, Beovu vision loss side effects have handed Novartis setbacks in its efforts to capture market share from Eylea. And in late May 2021, the latest development concerning Beovu safety issues has resulted in Novartis ending three key clinical trials, MERLIN, RAPTOR, and RAVEN.
To begin our coverage of what happened with these three terminated Beovu clinical trials, 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":
The Merlin trial, as well as the Raptor and Raven studies, were testing Beovu given every four weeks. The drug currently carries an FDA label for dosing every eight to 12 weeks after three initial monthly loading doses....
Novartis launched the Merlin trial to see if the more frequent dosing could help age-related macular degeneration patients who still have unresolved retinal fluid despite anti-VEGF therapy. On the efficacy front, 6 mg monthly Beovu matched up to 2 mg monthly Eylea in change in visual acuity after one year of treatment. The drug also bested Eylea on some anatomical secondary endpoints, Novartis said.
But 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.
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You can learn more about these three terminated Beovu clinical trials, MERLIN, RAPTOR, and RAVEN, by looking at their respective pages over at the CliniclTrials.gov website (accessed June 1, 2021):
- Study of safety and efficacy of brolucizumab 6 mg dosed every 4 weeks compared to aflibercept 2 mg dosed every 4 weeks in patients with retinal fluid despite frequent anti-VEGF injections (MERLIN).
- Assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (RAPTOR).
- Assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (RAVEN).
For a concise characterization of this latest Beovu vision loss side effects development, here is the beginning of a June 1, 2021 article by Endpoints News Senior Editor Amber Tong:
Safety concerns have forced Novartis to slam the brakes on a trio of late-stage clinical studies for its eye drug Beovu, marring grand ambitions to challenge the throne currently occupied by Regeneron’s Eylea.
If one is interested in how Novartis is seeking to present the current status of its lingering Beovu safety issues, this is 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". Significantly, it 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.
In the meanwhile, for background, we point out our June 17, 2020 article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020".
On a different front, we continue to investigate drug injury lawsuits against Novartis for Beovu when causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation. As we have reported previously, starting in January 2021, Beovu lawsuits have been filed for patients alleging Novartis failed to warn doctors and patients about these Beovu vision loss side effects.
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