Recent studies and reports have found an association between Beovu and retinal vasculitis with vision loss. This comes only months after it received FDA approval.
What Is Beovu?
Brolucizumab-dbll, known by the brand name Beovu, is a vascular endothelial growth factor (VEGF) inhibitor. It is intended to treat wet AMD (age-related macular degeneration). Beovu is manufactured by the Swiss pharmaceutical giant Novartis. It is administered via intravitreal injection. Beovu comes in a 6mg single-use vial. The recommended dose is a monthly injection for the first three months. This is followed by an injection every 8-12 weeks. The FDA approved Beovu in October 2019.
What Are Beovu’s Common Side Effects?
The following are some of Beovu’s common side effects:
- Blurred vision
- Conjunctival hemorrhaging
- Eye pain
- Eye floaters
February 2020 Safety Review Announcement
Around the end of February 2020, Novartis announced that they were conducting an external safety review of Beovu. This report came days after the American Society of Retina Specialists (ASRS) expressed concern over its side effects. At the time, the ASRS reported 14 Beovu-related vasculitis cases. Eleven of them involved occlusive retinal vasculitis. Despite the safety review announcement, Novartis publicly continued to stand behind Beovu’s safety and efficacy.
April 2020 Novartis Safety Review and Update
Less than two months later, on April 8, 2020, Novartis announced the safety review’s completion. They evaluated cases that involved severe vision loss, retinal artery occlusion, and vasculitis in Beovu patients. Based on their evaluations, Novartis acknowledged that at least some Beovu patients may experience retinal vasculitis or retinal occlusion with severe vision loss. They also announced that they were updating Beovu’s safety and warning information to include these complications.
May 2020 American Journal of Ophthalmology
In the May 2020 edition of the American Journal of Ophthalmology, two ophthalmologists argued that the use of Beovu should be halted until researchers discover its causal relationship with retinal vasculitis. They argued that the ASRS and Novartis did not go far enough by failing to recommend a moratorium on Beovu injections. The ophthalmologists also noted that other medications used to treat wet AMD are not associated with retinal vasculitis. This means that wet AMD patients can use other medications without putting their vision at risk.
June 2020 Safety Information Update
On June 11, 2020, Novartis announced that the FDA approved their update to the Beovu safety label. It now included information on Beovu’s association with retinal vascular occlusion and retinal vasculitis.
July 2020 Journal of VitreoRetinal Diseases Study
A published study in the July 2020 edition of the Journal of VitreoRetinal Diseases journal found that Beovu-associated retinal vasculitis was associated with significant vision loss. They found that 26 eyes of 25 Beovu patients had retinal vasculitis. Over 90 percent showed intraocular inflammation signs. The researchers also found that these signs occurred 25 days after the patient’s last Beovu injection. Retinal imaging revealed that 91% of vasculopathy cases occurred in retinal arteries, 79% in retinal veins, and 48% in choroidal vessels. Retinal vascular occlusive disease occurred in 83% of cases. The researchers found some patients were asymptomatic, while others experienced severe vision loss. They recommended that potential Beovu patients be examined for inflammation.
October 2020 Ophthalmology Study
The October 2020 issue of Ophthalmology, the American Academy of Ophthalmology’s journal, featured a study on Beovu-related retinal vasculitis and intraocular inflammation (IOI). The researchers concluded that these complications can cause vision loss. They examined Beovu patients who suffered from retinal vasculitis and IOI. The researchers found that their mean visual acuity declined 25 days after the last Beovu administration. This means that Beovu-related complications are severe and may result in permanent vision loss.
November 2020 Novartis Statement
Around mid-November 2020, Novartis provided additional information on its safety review for Beovu. They found that Beovu patients with pre-existing intraocular inflammation or vascular occlusion were at high risk for retinal vasculitis or retinal vascular occlusion. Novartis reported that their risk rate was about 4 percent, while all Beovu-taking patients were less than 0.5 percent at risk. Despite this report, Novartis reiterated its confidence in Beovu as an important treatment option for wet AMD patients.
Will There Be a Beovu Class Action?
Our lawyers expect there will be a Beovu class action lawsuit. When there are enough cases, plaintiffs’ lawyers will be able to seek an MDL class action. How long will this take? Our guess is early 2020.
Beovu Lawsuits Are Coming
What this all means is that the FDA approved Beovu too soon, before its complications could be properly observed. While Novartis conducted a safety review and updated their label warnings, they have failed to issue a recall. This shows that it is more interested in profits than public safety. If you are taking Beovu, please immediately contact your doctor. They will evaluate your condition to help prevent you from developing Beovu-related complications. And then contact us and talk to a lawyer about your options for compensation for the harm you have suffered.
Contact Miller & Zois About Beovu Vision Loss Lawsuits
If you had an adverse reaction after a Beovu injection, you may be entitled to financial compensation. Contact our Beovu injury lawyers today for a free consultation.