Home Beovu

Beovu Eye Injection Risks and Vision Loss Concerns

Beovu is a medication that treats eye problems like age-related macular degeneration. It has serious potential risks, including retinal vasculitis and retinal artery occlusion. Learn about Beovu safety warnings and what to do if you experience side effects after taking the drug.

Beovu (brolucizumab) is an injectable medication that treats various eye conditions, including age-related macular degeneration.

Unfortunately, Beovu may cause significant health concerns. Side effects include retinal vasculitis, retinal artery occlusion, blurred vision and eye pain. Some of these issues were initially undisclosed by the drug’s manufacturer, Novartis, leading many patients to file lawsuits.

If you’ve experienced Beovu side effects, monitor your symptoms, contact your ophthalmologist and keep records of your treatments.

What Is Beovu and What Is It Used For?

Beovu is a drug that treats wet age-related macular degeneration (AMD). It is administered via injection and was approved by the U.S. Food & Drug Administration (FDA) in 2019.

AMD is a condition that results in central vision loss. Vascular endothelial growth factor (VEGF) is a key component of AMD. VEGF is a protein that promotes irregular blood vessel growth underneath the area of your retina responsible for your central vision.

Beovu is a VEGF inhibitor. By limiting VEGF, Beovu prevents abnormal vessel growth, making it less likely for fluid to leak into your retina.

Beovu vs. Other AMD Treatments

When compared to other AMD drugs like Eylea and Lucentis, the benefits and downsides of Beovu vary based on the patient.

Clinical trials showed that people who received Beovu had slightly less improvement in the ability to read letters in a vision exam than those who received Eylea. However, a third of the Beovu patients had improvements in their ability to see details from a distance compared to a fourth of Eylea users.

Lucentis differs from Beovu because it can be administered via a refillable, surgically implantable device called a port delivery system. Studies also showed Lucentis improved users’ sight by several lines on the eye chart after multiple injections, but the gains were reversed over time.

Vision Loss Risks and Inflammatory Side Effects of Beovu

Shortly after Beovu was released, evidence began to surface showing side effects like temporary or permanent vision loss, inflammatory issues and more.

Research in EyeNet Magazine confirmed an estimated incident rate of 10.5% with the medication. Most issues (81%) happened during the first three months of treatment. Floaters, blurred vision and decreased vision were the most commonly reported symptoms.

Retinal Vasculitis

Retinal vasculitis is when inflammatory changes occur in your retinal arteries and/or veins. It can cause complications that threaten your vision. Common symptoms include blurred vision, blind spots, flashes, floaters, visual distortions and changes in how you see color.

The condition gets progressively worse. It starts with inflammation and can lead to complications like hemorrhages and retinal detachment if not treated.

Beovu has been linked to retinal vasculitis. On February 23, 2020, the American Society of Retina Specialists revealed it received reports of 14 cases of vasculitis, including 11 cases that the reporting provider said were occlusive retinal vasculitis.

Retinal Artery Occlusion

Retinal artery occlusion occurs when cholesterol buildup or a blood clot blocks blood flow to one or more of your retina’s arteries. It is typically painless, but it could cause you to completely lose your vision. You may also experience blind spots, distorted vision or peripheral vision loss.

Evidence suggests that Beovu use may contribute to the development of this condition. A HAWK and HARRIER trials safety audit revealed a 2.1% incidence of Beovu patients developing vascular occlusion with retinal vasculitis.

Blurred Vision or Vision Loss

Blurred vision was one of the most common side effects reported by patients who received Beovu injections. The drug’s manufacturer, Novartis, reported that 10% of patients experienced blurred vision.

Novartis also revealed that vision loss was reported in 1% of patients.

Eye Pain, Redness and Inflammation

Eye pain, redness and inflammation are common after receiving a Beovu injection. Novartis reported that 5% of Beovu patients experienced eye pain.

The manufacturer also suggests that Beovu users report any eye pain or redness to their doctors immediately. These symptoms can indicate retinal detachment or inflammation caused by infection.

Studies into the effectiveness of Beovu found that side effects of the medication included increased eye inflammation. One study determined that inflammation quickly resolved when patients were treated with a steroid medication.

Permanent Blindness

Many of the potential Beovu side effects, including retinal vasculitis and retinal artery occlusion, can result in severe and permanent blindness.

A study published in the American Journal of Ophthalmology Case Reports revealed that retinal vasculitis leading to severe vision loss had occurred after multiple injections. Researchers concluded, “It is not always possible to guarantee safety even if the patient has tolerated previous brolucizumab treatments without incidents.”

Timeline of Beovu Safety Warnings and Updates

The FDA originally approved the use of Beovu to treat wet AMD, but that decision was quickly followed by some key safety warnings and updates.

  • 2019:
    On October 7, 2019, the FDA authorized Beovu injections to treat patients with wet AMD. Approval was granted based on evidence from two clinical trials that included 1,459 patients between the ages of 50 and 97 who had been diagnosed with wet AMD.
  • Early 2020:
    Patients began experiencing adverse side effects. Concerns mounted about a potential link between Boveau use and the development of irreversible retinal vascular occlusion and/or retinal vasculitis that could rob people of their vision. An American Journal of Ophthalmology editorial urged doctors to stop using the medication until further research was completed.
  • April 2020:
    Novartis responded to the complaints of vasculitis and occlusion by funding a separate safety review. The results were released on April 8, 2020. In response to the safety study revealing new potential risk factors, Novartis indicated it would update prescribing information to include warnings about an increased risk of “retinal vasculitis and/or retinal vascular occlusion that could result in severe vision loss.”
  • June 2020:
    In June 2020, Novartis announced that the FDA had approved an updated safety label warning detailing the risk of adverse events.
Show More

The safety label warning update came too late for many patients. Some Beovu users are pursuing lawsuits to hold Novartis responsible for releasing a dangerous product and failing to alert patients to the medication’s risks.

Who May Be at Greater Risk for Complications?

Some patients face a greater risk of complications from Beovu use than others. This includes patients with:

  • A history of intraocular inflammation
  • Infections in or around their eyes
  • Hypersensitivity to Beovu or any of the inactive ingredients in it
  • A history of prior anti-VEGF injections
  • Underlying autoimmune or vascular conditions
  • More fragile retinal blood vessels due to their age

Novartis recommends that patients who are pregnant or breastfeeding exercise caution when using Beovu. The manufacturer also cites potential reproductive risks and mentions that the drug has not been studied for pediatric use.

What To Do if You’ve Experienced Beovu Side Effects

If you have experienced side effects associated with Beovu, there are a few key steps to take.

  • Monitor your symptoms: Common symptoms of Beovu complications include blurred vision, eye pain and sudden vision loss. Monitor yourself for any of these concerns.
  • Call an ophthalmologist immediately if symptoms arise: Alert your ophthalmologist to any symptoms you experience to ensure that you receive proper treatment.
  • Ask for imaging to detect inflammation: Tests like an optical coherence tomography (OCT) or fluorescein angiography can help detect and document potential complications in your retina.
  • Report adverse events to the FDA (MedWatch): It's important that the FDA has accurate information about medication side effects to issue warnings to others and make decisions on regulatory actions.
  • Save all treatment records and follow-up visits: If you want to pursue a claim against Novartis for Beovu side effects, hold onto documentation showing that you developed complications and received treatment.

If you experienced side effects, consider contacting an attorney to see if you can take legal action. Many Boveau lawsuits have been filed against Novartis for injuries the medication caused and for the company’s failure to provide adequate warnings about its risks.

Please seek the advice of a medical professional before making health care decisions.