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Following reports of serious Beovu adverse events such as vision loss, Novartis added new warnings to its injectable eye medication.
What is Beovu?
Beovu is an injectable medication given to patients with wet age-related macular degeneration (AMD). Wet AMD occurs when new blood vessels grow within the eye and disrupt vision. Beovu treats wet AMD by suppressing the human vascular endothelial growth factor (VEGF) responsible for the growth of blood vessels in the eyes.
Like any medication, Beovu may be associated with side effects. According to Medical News Today, common Beovu side effects include:
- Blurry vision
- Cataracts
- Broken blood vessels in the eyes
- Moving spots in vision called “floaters”
- Eye pain
- Eye swelling
- Pink eye
- Changes in vision
Unfortunately, the eye injection may also be associated with additional, more severe side effects including vision loss.
What Are Beovu Adverse Events?
Numerous reports detail Beovu adverse side effects such as retinal vasculitis and retinal vascular occlusion. Retinal vasculitis is an inflammation of the retina’s eye vessels, while retinal vascular occlusion is a blockage of these vessels. Both symptoms may occur along with general eye inflammation and can lead to severe vision loss.
Novartis, the manufacturer of Beovu, formed an external, independent safety review committee to evaluate the risk for these and other severe Beovu adverse events. According to this committee’s review of post market data, retinal vasculitis and/or retinal vascular occlusion occurred in every 6.99 out of 10,000 injections. Retinal vasculitis occurred alone after 1.69 out of every 10,000 injections while retinal vascular occlusion occurred in every 1.57 out of 10,000 injections. The two conditions occurred together in 3.73 out of 10,000 injections.
These adverse side effects recently prompted Novartis to nix three separate Beovu trials. The trials aimed to test more frequent dosing for Beovu patients but instead showed an increased risk of eye inflammation and other problems.
After Beovu adverse events were confirmed, Novartis added new warnings to the Beovu label. The new warnings, which the FDA later approved, details the risk for retinal vasculitis and retinal vascular occlusion.
“This label update provides clinicians with important information to guide treatment decisions. We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile,” Marcia Kayath, Global Head of Medical Affairs and Chief Medical Officer for Novartis, said in a press release.
Novartis continues to explore additional doses and uses for Beovu despite concerns over vision loss and other severe eye complications.
What Can I Do If I Was Impacted by Beovu Side Effects?
If you experienced Beovu adverse events, you may have legal options. Although the new label changes warn future patients about the risks for severe vision problems, original patients did not receive the same warning. This may allow patients to seek compensation for their injuries.
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