Beovu® Safety Concerns

Beovu (brolucizumab) is a drug that treats wet age-related macular degeneration (AMD). It works by stopping leakage from weak blood vessels into the retina. This slows disease progression and improves vision.

Beovu safety review and side effects

However, the American Society of Retina Specialists (ASRS) recently announced that Beovu may cause severe vision loss. Novartis, the company that owns Beovu, responded by launching a safety review of the drug.

Based on the review, Novartis updated its safety information to include more side effects. They continue to believe Beovu offers more benefits than risks. But, it may be good to talk to your doctor to see if Beovu is still the right treatment for you. If you continue using Beovu, your doctor can tell you what symptoms to watch for.

What is Beovu?

The FDA approved Beovu for the treatment of wet AMD in October 2019. It belongs to a class of drugs known as anti-VEGF therapies. VEGF stands for “vascular endothelial growth factor.” It is normally a healthy protein that supports the growth of new blood vessels.¹

What do anti-VEGF injections do?

But in the macula, VEGF is unhealthy. It promotes the growth of weak blood vessels behind the retina. These vessels can leak blood into the retina. This causes macular degeneration and vision loss. Beovu and other anti-VEGF drugs trap several types of VEGF. This blocks the formation of weak blood vessels and leakage into the retina. Anti-VEGF drugs are injected directly in the eye, usually on a monthly basis.¹

What are the side effects of Beovu?

Beovu has shown high success rates at slowing disease progression and improving vision quality. However, clinical trials found possible side effects of Beovu, which are similar to other anti-VEGF drugs. These include:²

• Endophthalmitis (interior eye fluid infection)
• Retinal detachment
• Increased pressure inside the eye
• Nonfatal stroke and heart attack
• Blurry vision
• Eye pain
• Floaters
• Cataracts

Contact your doctor if you notice redness, sensitivity to light, eye pain, or vision changes after treatment. In addition, people with active eye inflammation or infections should not be treated with Beovu.²

What are the updated safety concerns?

In February 2020, ASRS alerted its members that they noticed 14 cases of retinal vasculitis (inflammation of the retinal blood vessels). Of these, 11 led to vision loss. This was not a side effect associated with Beovu or any anti-VEGF drug.³

3 new side effects

Following the ASRS alert, Novartis launched a safety review of Beovu to look into 3 newly identified side effects that cause severe vision loss:⁴

• Retinal vasculitis
• Retinal vascular occlusion (blocked blood flow to or from the retina)
• Combination of retinal vasculitis and retinal vascular occlusion

The safety review confirmed that these adverse effects may occur following Beovu injection. They typically happen in the presence of eye inflammation. Novartis is now updating the Beovu safety information to include these warnings.⁴

Working to identify the causes and risks

Novartis is working to identify the causes and risk factors of these side effects. As of now, the company says to expect about 6 cases of these side effects per 10,000 injections. But they note that this number may be higher because of under-reporting and incomplete documentation.⁴

What are the recommendations for Beovu users?

Reports indicate that these side effects may occur early in Beovu treatment. Within one or two weeks of treatment, some people report having floaters or blurry vision.⁴

Eye inflammation seems to increase chances of experiencing these side effects. So doctors should examine you this before injecting Beovu. And you should contact your doctor if you notice vision changes or signs of inflammation, such as eye pain, floaters, or discomfort.⁴

If you are starting Beovu treatment or currently using Beovu, you may want to discuss this with your doctor. Here are some questions you to ask them:

• Is Beovu still a safe treatment in my situation?
• When would Beovu no longer be a safe treatment for me?
• What symptoms should I look out for after injections?
• Is there a different treatment option?
• Should I use a different treatment until we have more information about Beovu?