Serious Beovu side effects may occur among patients who receive the eye injections, according to updated warnings from the U.S. Food and Drug Administration (FDA).

Pharmaceutical company Novartis makes Beovu (brolucizumab), which was approved by the FDA in October 2019 as an injectable medication to treat wet age-related macular degeneration.

Two Types of Age-Related Macular Degeneration

As people age, they may experience an increased risk of macular degeneration, according to Low Vision Specialists of Maryland and Virginia. Nearly 90% of age-related macular degeneration cases involve “dry” macular degeneration, which means blood vessels in the eye do not leak but do cause some vision impairment.

The other 10% are cases of “wet” age-related macular degeneration, which means the disease has advanced to the point abnormal blood vessels grow and leak into parts of the eye where they should not—particularly the macula. The macula is below the middle of the retina and is responsible for central vision. When leaking and bleeding occur from wet AMD, the patient can experience permanent loss of vision.

Dry age-related macular degeneration can progress to wet AMD. Sometimes, this occurs before the disease is diagnosed.

Diagnosis of wet AMD typically involves an examination of the macula by an eye doctor, vision tests, and imaging tests that help doctors visualize the blood vessels and surface in the retina, according to the Mayo Clinic. Many imaging tests will be repeated throughout treatment to see how a patient’s wet AMD progresses.

AMD Treatment

If left untreated, age-related macular degeneration can have serious consequences. The most concerning complication of this condition is vision loss. The permanent loss of vision is a life-changing disability. With AMD, vision loss primarily occurs in the central vision, which is necessary for driving a car, reading, and other activities. Peripheral vision is typically unaffected.

Vision loss can also lead to other problems, according to the Mayo Clinic, such as Charles Bonnet syndrome, a condition in which people with vision loss have visual hallucinations.

Prompt treatment of age-related macular degeneration is important in order for the patient to avoid long-term consequences. A low vision rehabilitation specialist can help patients adapt to the reduction or loss of their central vision. An occupation therapist, eye doctor, or other professional can also help with the rehabilitation process, according to the American Macular Degeneration Foundation.

Surgery may be an option for wet AMD treatment. For a long time, the only treatment option was a laser procedure that sealed the leaking blood vessels behind the macula.

More recently, medications have been developed to treat wet age-related macular degeneration. These medications inhibit vascular endothelial growth factors — molecules in the body while support the growth of new blood vessels. Examples of these medications are Lucentis (ranibizumab), Avastin (bevacizumab), Eyelea (aflibercept), and Beovu.

Unfortunately, Beovu side effects may be concerning.

Beovu Side Effects

Beovu is a prescription medication injected into the eye to suppress a human vascular endothelial growth factor that can lead to blood vessel overgrowth in the eye, according to the FDA.

Like any medication, Beovu does have side effects. Common, mild side effects may include a bloody eye, decreased vision, eye redness, or blurry vision, according to Beovu prescribing information from Novartis. In two Beovu clinical trials, the most common adverse reaction was blurry vision which occurred in 10% of patients.

Unfortunately, not all Beovu side effects are mild. Even though Beovu is designed to help prevent vision loss, some of the drug’s severe potential side effects may actually lead to vision loss.

In fact, the American Society of Retinal Specialists put up a red flag that patients who had received Beovu were more likely to suffer from retinal vasculitis and retinal vascular occlusion, according to Review of Opthalmology.

Novartis found retinal vasculitis, severe vision impairment, or retinal artery occlusion happened in 8.75 to 10.08 out of 10,000 Beovu injections completed between Feb. 28 and March 27, 2020. These findings prompted the FDA to approve a revised label in June that lets patients and their doctors know about the risks.

Beovu retinal vasculitis is a condition marked by the inflammation of the tiny blood vessels of the retina. This inflammation may cause visual difficulties, including a loss of peripheral vision. In some cases, the damage may be permanent.

Retinal artery occlusion means the retinal artery that carries oxygen to the nerve cells in the retina is blocked. As a result, the patient may suffer loss of sight due to lack of oxygen to the retina.

Dr. Kevin J. Blinder with the Retina Institute of St. Louis told Review of Opthalmology that the complication rates seen in real-world practice settings after the FDA approved Beovu appear to be higher than they were during clinical trials.

There’s speculation some patients may have an immune system reaction to Beovu.

“In the trials, there was some pre-existing brolucizumab antibody formation in patients who weren’t even injected yet,” Blinder told Review of Ophthalmology.

“Antibodies were present in 36 to 52 percent of the treatment-naïve patients. Once they had treatment, that went up to 53 to 67 percent of patients. Perhaps there’s an immune reaction to Beovu that causes these severe complications, but we don’t have any data to show that the ones that had this reaction were antibody-positive.”

According to Review of Opthalmology, the Retina Times reported 26 eyes of 25 patients developed retinal vasculitis during the ASRS Research and Safety in Therapeutics Committee case series. Blinder said the number was “certainly higher and more severe than anticipated.”

These risks prompted Novartis to end three Beovu safety trials in late May 2021, much earlier than expected. The trials aimed to study the safety of Beovu with more frequent dosing schedules, but revealed that the drug may be associated with higher instances of eye inflammation when compared to a competitor product.

Beovu Legal Action

Novartis is facing a lawsuit filed by a former employee who has accused the company of filing false data regarding the incidence of Beovu side effects. The former employee—who was the worldwide medical director for the Beovu brand—sued Novartis, alleging she was fired after she tried to release corrected data about Beovu, Becker’s Hospital Review reported.

In the lawsuit, she alleges that the incorrect statistics showed Beovu was much less likely to be linked to strokes or heart attacks than a competing drug, but in reality, the likelihood was nearly the same no matter which macular degeneration drug was used, according to STAT.

The lawsuit says the fired employee “reasonably believed that Novartis’ failure to disclose material information violated consumer safety laws, was fraudulent or criminal, and/or violated public policy concerning public health, safety, and welfare.”

Beovu Side Effects Lawsuit

When medical companies push their drugs under false pretenses, they can be held accountable through a class action lawsuit.

Novartis is facing allegations the company hid serious side effects of Beovu in order to encourage sales.

With no warnings to help doctors and their patients make the most informed decisions, consumers may have suffered severe vision impairment that could be permanent. Anyone who has incurred eye injuries after Beovu injections could benefit from speaking with an experienced attorney.