The U.S. Food and Drug Administration (FDA) approved the prescription drug Beovu (brolucizumab-dbll) in October 2019 for the treatment of wet age-related macular degeneration (AMD), a serious eye disease. Recent research, however, has suggested that patients taking the drug may have a slightly increased risk of retinal vasculitis and retinal vascular occlusion, serious eye disorders that can lead to vision loss.
Beovu Linked with Serious Eye Disorder
About four months after Beovu came onto the market, the American Society of Retinal Specialists (ASRS) alerted doctors to 14 reports of retinal vasculitis in patients who had taken it. Eleven of those patients had a more severe form of the condition called “occlusive retinal vasculitis,” which can lead to blindness.
Vasculitis is a general term for various conditions that cause inflammation in the blood vessels. In these cases, it was the blood vessels in the retina at the back of the eye that was affected. When the inflammation progresses, it causes the blood vessels to swell and stiffen, and can result in some of those vessels becoming completely blocked so that blood can no longer flow through. When this happens, it’s called “occlusive retinal vasculitis.”
Following the report from the ASRS, the manufacturer of the drug—Novartis—opened an investigation to find out what was going on. On April 8, 2020, the company issued a press release stating that it had concluded that investigation and determined that indeed, patients taking Beovu were at an increased risk for retinal vasculitis.
Novartis worked with the FDA to update the product warnings, and in June 2020, the FDA approved the new verbiage on the drug label, which indicated that the drug could increase the risk of retinal vasculitis and retinal vascular occlusion.
Unfortunately, patients taking the drug between October 2019 and June 2020 did not have the advantage of these warnings and thus were ill-informed about the potential risks of the medication when deciding to use it.
Studies Confirm Link Between Beovu and Retinal Vasculitis
While Novartis worked to update its product warnings, some eye health professionals expressed their concern about the use of the drug. In May 2020, the American Journal of Ophthalmology published an article from two ophthalmologists who argued that the use of Beovu should be halted until researchers could learn more about its potential link with retinal vasculitis.
“Our patients have alternatives without incurring this risk,” they wrote.
In July 2020, the Journal of VitreoRetinal Diseases published a study on patients who had taken the drug and then developed retinal vasculitis. The results showed that the cases occurred at a mean of 25 days after the most recent injection and significantly affected vision. Mean visual acuity before the event was 20/52, worsening to 20/151 at the time of the event, and 20/243 at the last follow-up.
The scientists concluded that patients taking Beovu should be carefully monitored for signs of active inflammation before each injection.
In October 2020, the scientific journal Ophthalmology published another study of patients taking Beovu who went on to develop retinal vasculitis. This time, scientists diagnosed the condition at a mean of 30 days after a Beovu injection. All of the patients suffered from deteriorating eyesight.
In November 2020, Novartis provided another update on its post-marketing review, reporting that patients with certain eye problems before being treated with Beovu had a nearly four percent higher risk of suffering from vision-threatening conditions after treatment. Those without these pre-existing conditions had a 0.5 percent increased risk of developing retinal vasculitis after starting Beovu.