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Beovu Lawsuit

Beovu Lawsuit

Beovu is an eye injection that is linked to dozens of reports of vision loss due to a side effect called retinal vasculitis.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Beovu induced injury cases in all 50 states. If you or somebody you know has been diagnosed with vision loss or blindness, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is the Problem?

Beovu (brolucizumab) is an injection that is used to treat neovascular (wet) age-related macular degeneration (or “wet AMD”). Since Beovu approved by the FDA in late 2019, dozens of patients have been diagnosed with severe vision loss or blindness due to side effects.

What Happened?

Beovu injections can potentially damage a patient’s vision by causing severe inflammation. Tragically, many patients believed that their vision would improve when they were injected with Beovu — but instead, they suffered devastating vision loss, blindness, and other eye injuries.

What Should I Do?

Novartis urges patients on Beovu to seek immediate care from an ophthalmologist if their eyes become red, sensitive to light, painful, or develop vision changes (i.e. blurry vision, floaters).

What Eye Injuries Are Linked to Beovu?

Beovu lawsuits accuse Novartis of failing to warn patients and doctors about the risk of severe eye injuries, such as:

  • Vision Loss
  • Blindness
  • Retinal Artery Occlusion
  • Occlusive Retinal Vasculitis
  • Retinal vasculitis
  • Intraocular Inflammation
  • Eye Inflammation
  • Uveitis
  • Other Eye Problems

What Are Risk-Factors for Beovu Patients?

In February 2020, the American Society of Retinal Specialists issued a warning about cases of intraocular inflammation, some of which led to severe vision loss, in patients using Beovu.

Patients with the highest risk of severe eye injuries within 6 months of receiving Beovu were those who had prior eye inflammation and/or vascular occlusion in the 12 months before their first injection of Beovu, according to Novartis.

Source: “Novartis identifies possible risk factors for Beovu patients”— November 14, 2020 (Reuters)

What is Beovu?

Beovu (brolucizumab) is an eye injection made by Novartis. It was approved by the FDA in October 2019 for the treatment of wet age-related macular degeneration (also called “wet AMD”). Beovu was initially advertised as a longer-lasting treatment for wet AMD, but instead, many patients developed severe inflammation possibly as a result of delayed hypersensitivity reaction to the drug.

Beovu Risks Include Severe Eye Inflammation

Beovu is linked to a sight-threatening eye disease called “retinal vasculitis” (inflammation of the retina) that may cause blurry vision, distorted vision, or blindness. This eye disease is normally very rare, but Beovu was linked to 26 reports of “occlusive retinal vasculitis” in its first 6 months on the market. In some cases, patients lost most of their vision after just 2 doses of Beovu.

Beovu Is Only Drug In Its Class Linked to Retinal Vasculitis

Beovu belongs to a class of drugs called anti-VEGF therapy — but it is the only drug in this class that is linked to a type of eye inflammation called “retinal vasculitis,” which can lead to vision loss and blindness.

“Brolucizumab is not the only drug that can be used for the treatment of eAMD. In the face of the known risk, its use is unwarranted.” – American Journal of Ophthalmology, Is This a 737 Max Moment for Brolucizumab? (May 25, 2020)

What is Retinal Vasculitis?

Retinal vasculitis is an eye disease that involves inflammation of the blood vessels in the retina. In severe cases, it can cause permanent vision loss and blindness. The retina is a layer of tissue inside the eye that senses light and sends signals to the brain.

Signs & Symptoms of Retinal Vasculitis

  • Eye redness
  • Sensitivity to light
  • Eye pain
  • Changes in vision
  • Blurry vision
  • Increase in floaters
  • Vision loss
  • Blindness

Case Report: Woman Loses Vision After 2 Doses of Beovu

In an alarming new case report, a 77 year-old woman who had only 2 injections of Beovu lost most of her vision in her right eye.

The woman had blurry vision after her second Beovu injection, but thought it was temporary. Three weeks later, she returned to her doctor’s office due to severe vision loss. She was diagnosed with retinal vasculitis.

Source: “Retinal Vasculitis After Administration of Brolucizumab Resulting in Severe Loss of Visual Acuity.” — JAMA Ophthalmol. 2020

How Common Are Serious Eye Problems From Beovu?

After dozens of patients developed serious eye problems from Beovu during clinical trials, Novartis’s safety committee discovered that the risk was highest for patients who already had eye inflammation before they were injected with Beovu.

Further studies showed that retinal vasculitis, retinal vascular occlusion, or both together, occurred in roughly 7 out of every 10,000 injections with Beovu. Retinal vasculitis and retinal vascular occlusion occurred in about 2 out of every 10,000 injections. Together, these eye injuries occurred in 4 out of every 10,000 injections.

Beovu Linked to 4% Risk of Eye Inflammation

Due to the risk of serious eye problems, Novartis asks doctors to check patients for intraocular inflammation before injecting Beovu. However, Beovu itself is linked to a 4% risk of intraocular inflammation. When Beovu patients develop eye inflammation, it may increase their risk of serious eye problems with each additional injection of Beovu.

Patients With Prior Eye Inflammation Have Highest Risk

In November 2020, Novartis warned that Beovu patients with certain retina problems may face a higher risk of severe vision loss and other vision-threatening side effects, such as retinal vasculitis or retinal vascular occlusion.

According to a study of 12,000 Beovu patients, the patients who had the highest risk of Beovu retinal problems were the patients who had prior eye inflammation and/or retinal occlusion in the 12 months before their 1st Beovu injection.

Novartis Confirms Beovu Vasculitis Risk

In February 2020, the American Society of Retina Specialists (ASRS) warned about reports of severe eye inflammation in patients given Beovu. By March 27, the group said it was aware of 26 cases of occlusive retinal vasculitis, which can lead to permanent blindness. In April 2020, Novartis investigated the reports and confirmed a risk of vision loss due to vasculitis.

FDA Updates Beovu Safety Warnings

In June 2020, the FDA approved a label update for Beovu with safety warnings about “retinal vasculitis” and “retinal vascular occlusion.” Dr. Paul Hahn, an expert who moderated a panel on drug safety, warned that: “1 in 200 represents the overall risk of any patient beginning [Beovu] therapy losing six or more lines of vision due to occlusive vasculitis.”

What is Wet Age-Related Macular Degeneration?

Wet age-related macular degeneration is an eye disease that affects millions of people globally. The symptoms may include blurry vision, blind spots, dark spots in the center of their vision, or distorted vision.

Has Novartis Paid Any Beovu Lawsuit Settlements?

At this time, there have not been any mass-tort lawsuit settlements involving Beovu patients who developed vision loss and blindness.

Is There a Bevou Recall?

Beovu has not been recalled due to patients suffering eye problems, vision loss, or blindness. Instead, Novartis and the FDA are currently investigating the potential risk of these side effects. If they determine that the risk outweighs any benefits, a recall for Beovu may be required by the FDA or implemented voluntarily by Novartis.

Do I have a Beovu Lawsuit?

The Schmidt Firm, PLLC is currently accepting Beovu induced injury cases in all 50 states. If you or somebody you know has been diagnosed with vision loss or blindness, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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