Table of contents
- Latest Beovu Lawsuit Updates
- September 14, 2020: Europe Adds Retinal Vasculitis Warning to Beovu Label
- August 6, 2020: JAMA Ophthalmology Publishes Case Report
- July 1, 2020: Retina Specialists Publish Case Series
- June 1, 2020: Retinal Physician Reports Call to Halt Beovu Use
- May 25, 2020: Editorial Calls for Stopping Brolucizumab Injections
- March 2, 2020: Novartis Updates Beovu Safety Review
- February 23, 2020: Retina Specialists Report 14 Vasculitis Cases
- What Is Beovu?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- What Does the Research Say About Beovu and Vision Loss?
- What Should I Do If My Vision Changes After a Beovu Injection?
- Does Beovu Dosing Frequency Affect the Risk?
- What Has Novartis Said About Beovu’s Safety?
- How Many Beovu Cases Had Been Reported by March 2020?
Patients given Beovu (brolucizumab-dbll) injections for wet age-related macular degeneration have reported retinal vasculitis and vision loss. Novartis makes the drug and disputes calls to halt its use. Claims about these injuries are allegations. No court has ruled on them.
No MDL, recall or federal court docket is tied to Beovu. The drug is still sold, with an FDA label warning about retinal vasculitis.
The FDA label, revised in July 2024, says to discontinue treatment if retinal vasculitis or occlusion develops. Each claim is reviewed on its own facts.
Latest Beovu Lawsuit Updates
September 14, 2020: Europe Adds Retinal Vasculitis Warning to Beovu Label
On September 14, 2020, Novartis announced a label update for Beovu. A committee of the European Medicines Agency approved it. The update adds retinal vasculitis and retinal vascular occlusion, typically with intraocular inflammation [1].
The changes appear in sections 4.4 and 4.8. The update applies in all 27 EU member states, the UK, Iceland, Norway and Liechtenstein.
August 6, 2020: JAMA Ophthalmology Publishes Case Report
JAMA Ophthalmology published an online case report on August 6, 2020. A 77-year-old woman lost sight in her right eye after a second brolucizumab dose for wet AMD [2].
Her vision was 20/200 about three weeks after the injection. The report describes one patient and does not show what happened to others.
July 1, 2020: Retina Specialists Publish Case Series
On July 1, 2020, the Journal of VitreoRetinal Diseases published a case series from the American Society of Retina Specialists. It described retinal vasculitis in 26 eyes of 25 patients after brolucizumab [3].
The cases were reported as of April 1, 2020. The authors concluded that some eyes had significant vision loss. Those numbers come from reports, not from a trial.
June 1, 2020: Retinal Physician Reports Call to Halt Beovu Use
Retinal Physician reported on June 1, 2020 that two retina specialists had written an editorial. It called for a halt to Beovu use [4]. Novartis “strongly disagrees,” and Beovu stays on the US market.
May 25, 2020: Editorial Calls for Stopping Brolucizumab Injections
The American Journal of Ophthalmology published the editorial “Is This a 737 Max Moment for Brolucizumab?” on May 25, 2020. It said “intravitreal injections of brolucizumab should stop” until investigations conclude [5].
The editorial is an opinion piece by physicians. It is not an action by any regulator, and it did not decide the question.
March 2, 2020: Novartis Updates Beovu Safety Review
Novartis said on March 2, 2020 that more than 57,000 Beovu vials had shipped to US physicians. Its safety team was reviewing a limited number of reported cases of severe vision loss, inflammation and potential retinal vasculitis [6].
The company said it “stands behind the safety and efficacy of Beovu when used as indicated” while its review continued.
February 23, 2020: Retina Specialists Report 14 Vasculitis Cases
On February 23, 2020, ASRS alerted members to 14 cases of vasculitis after Beovu approval on October 7, 2019. Eleven were designated occlusive retinal vasculitis [7]. The American Academy of Ophthalmology reported the alert in EyeNet.
What Is Beovu?
According to its FDA label, Beovu is a human VEGF inhibitor. VEGF stands for vascular endothelial growth factor. It is injected into the eye for wet age-related macular degeneration and diabetic macular edema [8].
Beovu is the brand name of brolucizumab-dbll. It received initial US approval in 2019. Claims about it focus on the retinal vasculitis its label warns about.
Who May Be Affected?
People who had Beovu shots in the eye for diabetic macular edema or wet AMD may be affected. This is most true if you had eye inflammation, retinal vasculitis or vision loss afterward.
The label says these immune-mediated events “may occur following the first intravitreal injection.” In the same ASRS series, inflammation began a mean of 25 days after the last injection. The range was 3 to 63 days.
Whether you qualify for a claim depends on an individual legal review of your records and the events that followed your injections.
Reported Injuries or Damages
Alleged and reported Beovu injuries include retinal vasculitis, retinal vascular occlusion, intraocular inflammation and vision loss. The FDA label lists the first two under Warnings and Precautions. These are reports and associations. They are not court findings.
In the ASRS series, 92% of cases involved intraocular inflammation. Twelve eyes (46%) had a final vision of 20/200 or worse. Imaging showed occlusive disease in 83% of eyes.
A second study looked at 15 eyes of 12 patients, all women, from 10 US centers. AAO EyeNet called it the first peer-reviewed case series after isolated reports [9].
Nine eyes (60%) lost 3 or more lines of vision, and five (33%) were reported to have vision below 20/200 after treatment.
Recall and Regulatory Background
The FDA label was revised in July 2024. It tells prescribers to discontinue treatment in patients who develop retinal vasculitis or retinal vascular occlusion. The regulator record consists of label warnings.
Evidence to Preserve
Keep these records, because they can show what happened and when:
- Medical records and imaging of the eye, such as clinic notes, retinal scans and angiograms
- Injection dates, doses and the name of the treating retina specialist
- The drug lot number, if it was recorded
- Visual acuity results from before and after treatment
- Pharmacy and insurance records
- Photographs or notes of symptoms such as floaters, redness, pain or blurred vision
- Communications with your doctor or Novartis
- A log of costs and missed work
Filing Deadlines
State law sets the time limit for a Beovu claim, and the limit depends on where you live and when the vision problem began or was diagnosed.
Some states start the clock at diagnosis. Even a strong claim can end once a deadline passes. Talk to a lawyer soon, so you keep the chance to file.
Frequently Asked Questions
What Does the Research Say About Beovu and Vision Loss?
Research on Beovu and vision loss consists of case reports and series from 2020. In the JAMA Ophthalmology report, vitreous cultures and PCR were negative. These studies show an association. They do not prove cause.
What Should I Do If My Vision Changes After a Beovu Injection?
If your vision changes after a Beovu injection, report it without delay, as the label instructs. Seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light or painful.
Does Beovu Dosing Frequency Affect the Risk?
Beovu dosing frequency may affect the risk. In the MERLIN study, wet AMD patients on every-4-week dosing had more inflammation and vascular occlusion than patients dosed every 8 or 12 weeks. The label says doses should be at least 8 weeks apart.
What Has Novartis Said About Beovu’s Safety?
Novartis said in March 2020 that its review supported an overall favorable benefit-risk profile and that there was no validated new or changed safety signal. Retinal Physician later reported a company rate of 3.73 per 10,000 injections for retinal vasculitis and occlusion.
How Many Beovu Cases Had Been Reported by March 2020?
By March 27, 2020, 26 cases tied to 70,000 injections and 37,000 treated patients had been reported to the ASRS ReST Committee. The American Journal of Ophthalmology editorial gave those figures. They are reports and not proof of cause.