Have you or a loved one taken Beovu® to treat wet age-related macular degeneration, and later experienced a deteriorating vision, blindness or other harmful side effects?
If your answer is yes, you may be entitled to participate in Beovu lawsuits currently being filed in courts throughout the U.S.
Recent reports linking Beovu to significantly increased risks of severe vision loss have raised important safety concerns about the product. Contact our experienced Beovu lawsuit attorneys today to learn more and to ensure you receive the financial compensation you deserve.
What is Beovu, and What is it Used For?
Beovu is an eye drug produced by Novartis Pharmaceuticals as a treatment option for wet age-related macular degeneration (AMD).
AMD is a common chronic eye disorder that occurs when an oversupply of vascular endothelial growth factor (VEGF) causes abnormal growth of blood vessels in the eye. Fluid from these blood vessels leak into the eye and blur the clear central vision needed for driving, reading and other activities.
"Wet" AMD, or advanced neovascular AMD, is a severe eye disease that can damage a part of the eye called the macula, and lead to central vision loss. As the disease progresses, people see blurry areas or blank spots that severely hamper their vision.
Wet AMD is typically treated with anti-VEGF drugs that are administered by intravitreal injection. These macular degeneration drugs stifle the growth of abnormal blood vessels, which prevents excess fluid from leaking into the eye.
Beovu (brolucizumab-dbll) is an anti-VEGF prescription drug produced by Novartis, which the drugmaker hoped would compete with Regeneron's leading anti-VEGF product, Eylea. Based on findings from the HAWK and HARRIER clinical trials that seemed to indicate that Beovu was safe, the FDA approved the drug for the treatment of wet AMD in October 2019.
Beovu is Linked to Potential Vision Loss and Vision Problems
When Beovu was first approved by the FDA in October 2019, the product included warnings of common vision-related side effects such as blurred vision, sensitivity to bright lights, eye pain and blood vessel inflammation. However, in February 2020, the American Society of Retinal Specialists (ASRS) issued a report to its members with a very concerning development regarding Beovu.
The ASRS stated that since Beovu was approved on October 7, 2019, the ASRS had received reports of fourteen cases of vasculitis in patients who received Beovu injections. Eleven of these cases were reported as occlusive retinal vasculitis, the inflammation of blood vessels, or vascular branches, a condition that blocks blood vessels in the eye and can cause permanent vision loss. Within a month of this report, the ASRS updated its findings, reporting twenty-five cases of retinal vasculitis, with twenty-one involving occlusion.
A retinal vasculitis is a severe form of eye inflammation that is usually caused by a neurological disorder, infectious disease or autoimmune disease. Symptoms can be aggressive, and the inflammation of retinal blood cells can cause blurring of vision, streaks in vision, altered colour vision and other visual distortions. In many cases, it can lead to severe vision loss.
Retinal vascular occlusion, which has affected some Beovu users, primarily affects the blood vessels of the retina by causing blood to build up and preventing the retina from filtering light. These fluids can cause severe visual disturbances and peripheral vision loss, and may ultimately lead to permanent vision loss.
Beovu has also caused retinal detachment in some patients, which is an emergency situation in which retinal cells at the back of the eye separates from the layer of blood vessels that provide it with oxygen and nutrients. Retinal detachment can lead to permanent vision loss.
In August 2020, JAMA Ophthalmology reported on a case of a 77-year old woman who had previously taken bevacizumab and aflibercept for wet AMD and never experienced eye inflammation with either drug. However, after taking Beovu, she was diagnosed with retinal vasculitis and acute loss of vision in her right eye.
Significantly, Novartis did not include any warnings about these severe vision risks or vision-related adverse events in its product packaging when Beovu was first sold to the public.
Novartis Revises Beovu® Drug Label
After receiving these reports of vasculitis and concomitant occlusion from the ASRS, Novartis announced that it would conduct a comprehensive review of the reported cases, conducting both an internal review of the adverse effects reported by the ASRS and also commissioning an external safety review of Beovu. The external safety review found that 3.3% of their trial participants experienced retinal vasculitis, and 2.1% also had vascular occlusion.
The drug maker concluded 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," and applied to the FDA for approval to add warnings concerning these potential side effects to its product packaging.
On June 9, 2020, the FDA issued a label change approval letter for Beovu, approving Novartis's revision of its product labelling for Beovu, adding a new warning about the risks of retinal vasculitis and retinal vascular occlusion.
Beovu Lawsuits - Vision Loss and Vision Problems
All drug manufacturers and pharmaceutical companies have an obligation to warn patients and medical professionals of the risks and adverse effects of the drugs they sell. Patients, doctors and other health care professionals rely upon these disclosures and warnings when making critical patient safety and treatment decisions.
Currently, many patients who took Beovu® for the treatment of AMD are taking legal action to recover compensation for the loss of vision they have suffered. These lawsuits claim that Novartis put people at risk of developing retinal vasculitis, retinal vascular occlusion, retinal artery occlusion and severe vision loss by not including proper warnings in its product packaging.
Plaintiffs who bring defective drug lawsuits against drug companies like Novartis are seeking and deserve compensation for their losses, including past and future pain and suffering, medical expenses, lost wages and earning capacity and other damages.
Call the Rothenberg Law Firm Today
Between the time of Beovu's approval in October 2019 and the updating of its warning label in June 2020, over 50,000 doses of the drug were administered in the United States. If you or a loved one used Beovu® before June 9, 2020, and you are now suffering from vision loss, retinal vasculitis, retinal vascular occlusion, intraocular inflammation or other eye injuries, you may be able to bring a vision loss lawsuit against Novartis for its failure to provide sufficient warnings against the risk of vision loss when using its product.
Our dangerous drug lawyers approach the attorney-client relationship with compassion and are ready to help injury victims navigate the legal process during a very challenging time.
Contact the experienced Beovu lawyers at the Rothenberg Law Firm at 1-800-624-8888 or by filling out a contact form for a free, no-obligation confidential case evaluation with our defective drug litigation team and learn more about your legal options and the types of damages that may entitle you to compensation.