What is Beovu?
Manufactured and marketed by Novartis, Beovu (generic: brolucizumab-dbll injection) is a human vascular endothelial growth factor (VEGF) inhibitor used to treat Neovascular (Wet) Age-Related Macular Degeneration (AMD). The drug is administered by intravitreal injection, and the recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately every 25-31 days) for the first 3 doses, followed by 1 dose of 6 mg (0.05 mL) every 8-12 weeks. Beovu was approved by the U.S. Food & Drug Administration in October 2019.
What’s the Problem?
Recent lawsuits allege that Novartis failed to adequately warn patients that use of Beovu could result in vision loss, blindness, and other serious side effects. Former Beovu users have been diagnosed with vision problems including retinal vasculitis, retinal artery occlusion, intraocular inflammation and more.
The American Society of Retina Specialists (ASRS) in February 2020 issued a warning which stated that at least 25 cases of retinal inflammation (vasculitis) had been reported in patients who had received Beovu injections. Of these, 21 were also diagnosed with occlusive retinal vasculitis (retinal occlusion), an inflammatory eye condition that can lead to blindness.
Beovu Side Effects
- Vision loss
- Retinal vasculitis
- Retinal artery occlusion
- Intraocular inflammation
Common side effects of Beovu may include:
- Blurred vision
- Bleeding in the eye
- Eye pain
- Eye “floaters”
Beovu Blindness Investigation
A study published in the July 2020 edition of the Journal of VitreoRetinal Diseases found that retinal vasculitis had been identified in multiple patients who had recently undergone injections with Beovu. “Although a few eyes in this series were asymptomatic or minimally symptomatic, some eyes had significant vision loss,” the researchers said. “A careful examination for signs of active inflammation prior to [Beovu (brolucizumab)] injection is recommended.” The authors concluded by stating that once vasculopathy is suspected, angiographic imaging may help define the spectrum of involvement; however, optimal treatment strategies remain unknown.
“Stop Beovu Injections Now”: Editorial Warning
In May 2020, an editorial piece published in the American Journal of Ophthalmology stated that use of Beovu injections should be discontinued until the cause of eye inflammation associated with the medication is identified. “As this process plays out, it is our view that intravitreal injections of [Beovu (brolucizumab)] should stop,” the author said. “[Beovu (brolucizumab)] is not the only drug that can be used for the treatment of [exudative age-related macular degeneration (eAMD)]. In the face of the known risk, its use is unwarranted.”
EMA Approves Beovu Label Change to Include Retinal Vasculitis, Vascular Occlusion Warning
Novartis in September 2020 announced that the Committee for Medicinal Products for Human Use (CHMP) had approved an update to the Beovu Summary of Product Characteristics to include warnings about retinal vasculitis and retinal vascular occlusion. “Typically, these events occurred in the presence of intraocular inflammation,” Novartis said in the announcement. “This approval follows Novartis’ announcement that it would pursue worldwide label updates after a review and further characterization of post-marketing safety events reported to Novartis.”
Woman Diagnosed With Vasculitis After 2 Beovu Injections: JAMA Study
In August 2020, a study published in JAMA Ophthalmology described the case of a 77-year-old woman who suffered from acute visual acuity loss in her right eye following her second administration of Beovu for neovascular age-related macular degeneration. The woman had previously been treated with both Avastin (generic: bevacizumab) and Eylea (generic: aflibercept) since her initial diagnosis in 2018, but had never had any problems with either medication. After her first injection with Beovu, the woman immediately noted blurry vision, which she believed would be temporary. However, she returned to the office 3 weeks later with a visual acuity of 20/200 OU.
Committee Reviews Safety Risks of Beovu
A Novartis safety review committee in July 2020 identified a rate of 4.6% intraocular inflammation (IOI) of all types associated with Beovu injections. Of these, there was a subgroup of 2.1% of patients who developed occlusive vasculitis, according to Paul Hahn, MD, PhD, who moderated the committee. “If you have a patient who presents to your office having occlusive vasculitis following recent Beovu, that patient has a 1 in 5 risk of at least six-line vision loss,” Hahn said.
What is Vasculitis of the Eye?
Vasculitis of the eye is caused by inflammation of blood vessels in the retina (retinal vasculitis). Retinal vasculitis ranges in severity from mild to severe. Damage to the blood vessels of the retina can cause partial or complete blindness.
Retinal Vasculitis Symptoms
- Decrease of visual acuity (blurry vision)
- Visual floaters
- Scotomas (dark spot in vision)
- Decreased ability to distinguish colors
- Metamorphopsia (distortion of images such as linear images)
Beovu Warning: Retinal Vasculitis Can Lead to Blindness
A February 2020 article published in Vantage titled “Safety Scare Knocks Novartis” describes essential information about emerging safety issues with Beovu:
“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,” said Amy Brown, author of the report. “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.”
Do I Have a Beovu Lawsuit?
The Pharmaceutical Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Beovu Lawsuits. We are handling individual litigation nationwide and currently accepting new vision loss cases in all 50 states.
If you or a loved one was injured by the side effects of Beovu, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.