On October 8, 2019, pharmaceutical company Novartis announced it had received approval from the U.S. Food and Drug Administration (FDA) to market the drug Beovu (brolucizumab). The FDA cleared Beovu as a treatment of wet age-related macular degeneration (AMD), a chronic eye disorder that causes blurred vision and visual distortions.
Just a few months later, the American Society of Retinal Specialists (ASRS) alerted doctors to 14 reports of vasculitis—an inflammatory condition affecting the eye—in patients who took Beovu. That number later rose to 25, with 21 of the patients suffering from a type of vasculitis that could lead to blindness.
At the time, there were no warnings on the product label about the potential risk for vision loss.
Chaffin Luhana is currently investigating cases in which patients took Beovu and then suffered serious eye damage and/or vision loss.
What is Wet Age-Related Macular Degeneration?
Age-related macular degeneration (AMD) is a common eye disease that damages the macula, which is located near the center of the retina at the back of the eye and is responsible for sharp, clear central vision. A leading cause of vision loss for people 50 years and older, AMD affects mainly central vision, creating a blind spot that makes it harder to read, see faces, do detailed or close-up work, and drive. Peripheral vision is typically left intact.
There are two types of AMD:
- Dry AMD: The more common form of AMD, this affects about 80 percent of those who have it. It causes the macula to thin, while tiny clumps of a protein called “drusen” develop on its surface. Over time, these clumps block central vision, leading to long-term vision loss.
- Wet AMD: A rarer and more serious type of AMD, this occurs when new, abnormal blood vessels grow under the retina. These can then leak blood and other fluids, scarring the macula and damaging vision. Wet AMD causes a more rapid loss of vision than dry AMD.
Currently, there is no way to treat dry AMD. Doctors do encourage patients to take supplements containing vitamins C and E, lutein, zeaxanthin, zinc, and copper, as these nutrients have shown some promise in protecting the health of the macula.
There are several medications available to treat wet AMD. These are called anti-VEGF drugs, and help reduce the number of abnormal blood vessels in the retina, while also slowing leakage. These drugs are administered into the eye via injection with a slender needle.
What is Beovu?
Beovu (brolucizumab) is a type of anti-VEGF drug. VEGF stands for “vascular endothelial growth factor” and is a protein produced responsible for producing new blood vessels. Anti-VEGF medicines block this protein, slowing the growth of blood vessels in the eye. Doctors use them to treat wet AMD, as well as macular edema, diabetic retinopathy, and retinal vein occlusion.
Before Beovu came onto the market, there were three main anti-VEGF medicines already available:
- Avastin: The FDA first approved this drug in 2004 to treat different types of cancer. It is also used “off-label” to treat wet AMD.
- Lucentis: The FDA approved this drug in 2006 for the treatment of wet AMD and other eye conditions. It’s similar to Avastin and has shown to be equally effective in slowing vision loss.
- Eylea: The FDA approved this drug in 2011 for the treatment of wet AMD as well as other eye diseases.
When the FDA approved Beovu in 2019, Novartis stated it was superior to Eylea when reducing fluid leakage in the eye, while requiring fewer injections—a plus for patients.
“Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” said Dr. Pravin U. Dugel, principal investigator of the HAWK clinical trial used to gain Beovu’s approval. “With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.”
The FDA based its approval of Beovu on the HAWK and HARRIER clinical trials, in which Beovo worked as well as Eylea in improving visual acuity in patients with wet AMD while showing greater efficacy at reducing retinal fluid. Beovu also exhibited a similar overall safety profile. The most common side effects included blurred vision, cataract, conjunctival hemorrhage, eye “floaters” and eye pain.
Beovu Linked with Retinal Damage
On February 23, 2020, the ASRS shared a letter with its members stating that since Beovu’s approval in October 2019, they had received reports of 14 cases of retinal vasculitis—a rare condition in which the blood vessels in the retina become inflamed.
In 11 of those reports, the patients had a unique type of vasculitis called “occlusive retinal vasculitis,” which means that at least some of the affected blood vessels had become blocked or closed off. This is a more serious type of vasculitis that is more likely to lead to permanent vision loss.
Vasculitis and severe vision loss on this scale had not been reported with any of the other three anti-VEGF medications.
Novartis responded to the letter stating it was aware of these reports but that it continued to stand behind the safety and efficacy of Beovu. Meanwhile, executives conducted an internal review of the reports, and engaged an external safety review committee (SRC) to further evaluate the data from the original Beovu clinical trials.
On April 8, 2020, Novartis issued a press release sharing the results of these reviews, concluding “that there is a confirmed safety signal of rare adverse events of retinal vasculitis and/or retinal vascular occlusion that may result in severe vision loss.”
Indeed, the SRC had found cases similar to those reported by the ASRS occurring during the HAWK and HARRIER trials—something Novartis had neglected to report. The SRC also noted that the overall rates of vision loss between the Beovu and Eylea groups were similar.
Novartis began work on updating the drug’s prescribing information worldwide. Before this, the material included with the drug warned of potential eye inflammations, visual acuity disease, and retinal artery occlusion as separate terms. Novartis promised to work with regulatory authorities to update that information and added it would continue to monitor any incoming data from the ongoing clinical trials.
On June 11, 2020, Novartis issued another press release notifying the public that the FDA had approved its update to the prescribing information for Beovu. The new verbiage included a warning about the risk of retinal vasculitis and retinal vascular occlusion. Despite these changes, Novartis had no explanation for why the drug may be causing these side effects in some patients.
Studies Show a Link Between Beovu and Retinal Vasculitis
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.
The doctors noted that by March 27, 2020, a total of 26 cases of the condition had been reported among patients taking the drug. In their opinion, neither the updated Novartis warning nor the ASRS reports did enough to protect patients.
“Our patients have alternatives without incurring this risk,” they wrote.
In July 2020, the Journal of VitreoRetinal Diseases published the results of a study on Beovu-associated retinal vasculitis. Most of 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.
Analysis of the retinal imaging found vasculitis in the retinal arteries, retinal veins, and choroidal vessels (occurring in the vascular layer of the eye). Occlusive disease was apparent in 83 percent of the eyes.
The scientists concluded that patients taking Beovu should be carefully monitored for signs of active inflammation before each injection. They added that optimal treatments for this condition “remain unknown.”
In October 2020, the scientific journal Ophthalmology published a second study of Beovu-related retinal vasculitis. All of the patients had been treated with other anti-VEGF drugs before switching to Beovu. Researchers diagnosed retinal vasculitis and intraocular inflammation in all the eyes at a mean of 30 days after a Beovu injection.
All of the patients suffered from deteriorating eyesight, with the researchers concluding that the disease was characterized by the variable occlusion of large and small retinal arteries or both. They added that the vasculitis could expand to affect the large retinal arteries around the optic nerve or macula, which could cause severe vision loss.
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 higher risk of suffering from vision-threatening conditions after treatment.
Overall, people with previously occurring eye inflammation or vascular occlusion before Beovu treatment had a 3.97 percent increased risk of developing retinal vasculitis afterward. Those without these pre-existing conditions had a 0.5 percent increased risk of developing retinal vasculitis after starting Beovu.
Types of Injuries Associated with Beovu
Injections with the wet AMD drug Beovu may result in the following types of injuries:
- Sudden change in vision, including a complete or partial loss of vision
- Blurry vision
- Changes in how you see color
- Straight lines may look curved (a condition called metamorphopsia)
- Blind spots
- Retinal vasculitis
- Occlusive retinal vasculitis
- Retinal artery occlusion
- Intraocular inflammation
Despite these concerns with eye damage, Beovu remains on the market. Novartis continues to stand behind the drug as a safe and effective treatment for wet AMD. That means patients remain at risk, particularly if they have pre-existing inflammatory conditions of the eye.
Over 70,000 patients took Beovu between October 2019 when it was approved and June 2020 when the warnings were updated. All of those patients lacked the knowledge they should have had about the drug’s potential risks and dangers. Those who trusted the manufacturer and who now suffer eye damage may be entitled to financial compensation.
If you took Beovu and were later diagnosed with retinal vasculitis or other forms of vision damage or vision loss, you may be eligible to file a Beovu lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.