The FDA approved Beovu, a treatment for wet age-related macular degeneration (wAMD), back in October of 2019. Now, not even two years later, there are changes that must be made to the safety label. The maker of the drug, Novartis, began investigating safety concerns at the beginning of 2020 after hearing postmarketing reports of safety concerns like retinal vasculitis and retinal vascular occlusion. This new safety data is not causing Beovu to be pulled from the market, but it is important that clinicians recognize and understand the new label information when treating their patients.

About Wet Macular Degeneration

Wet macular degeneration (wMD) is one of two forms of macular degeneration. The other form, which is the dry type, is much more common. In fact, wet macular degeneration always begins as the dry form. This chronic eye disorder leads to blurred vision or a blind spot in one’s visual field. In most cases, abnormal blood vessels grow into the macula before releasing blood or other fluids. These fluids then impact retinal function. Fluid can also leak from the choroid, which would cause a bump to form in the macula. Medical professionals aren’t quite sure why this happens, but they do know that it leads to symptoms like visual distortions, blurry spots in the field of vision, reduced central vision, trouble recognizing faces, issues with adapting to changes in light, lower brightness and intensity of colors, and problems reading due to the blurriness of print. This condition can also be age-related macular degeneration, which means just what the name suggests: older age is a reason for the condition.

There are treatments available; doctors may prescribe Eylea, Lucentis, Beovu, or Avastin. They may also utilize photodynamic therapy, low vision rehabilitation, and photocoagulation. All of these options can work together to slow disease progression, stop further vision loss, and possibly even recover some of the lost vision.

Changes to the Beovu Safety Label

Upon approval, there were already a number of possible side effects indicated on the safety label of the injected treatment, such as cataracts, blurred vision, eye pain, floaters in the vision, and subconjunctival hemorrhages. These effects were discovered during clinical trials. Now, more side effects have been identified in the real world.

Postmarketing reports informed Novartis that there had been fourteen cases of retinal vasculitis and retinal vascular occlusion, prompting them to conduct an internal review in the first quarter of 2020. While the review led them to update the label, they are standing by the efficacy and safety of Beovu. Marcia Kayath, the Chief Medical Officer and Global Head of Medical Affairs, stated,

We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile.

Novartis will continue to investigate these reports and side effects with a team of global experts, drug developers, researchers, and medical specialists. Not only will they try to understand how and why these side effects are occurring, but they will work to mitigate negative effects and improve treatment recommendations.

About Retinal Vasculitis and Retinal Vascular Occlusion

Retinal vasculitis occurs when the small blood vessels of the retina become inflamed. It can vary widely in severity, leading to partial or even complete vision loss. On the other hand, retinal vascular occlusion occurs when the small veins are unable to carry blood away from the retinas due to blockage. Therefore, the retina cannot filter light as it is supposed to, which can result in blurred vision or loss of vision.

How Did Novartis Miss These Side Effects?

The clinical trial process exists to test the safety and efficacy of drugs, so how did these two side effects slip through the cracks? Unfortunately, there are a number of ways that side effects can make it through trials without being discovered or reported to the FDA. These include:

• Agency bias
• Commitment bias
• Poor trial design
• Lack of funding
• Researching the wrong risks
• Concealing results
• Bad luck
• Failure to meet agency standards

In the end, there is no way to know for sure how this happened unless Novartis or the FDA reveal further data. For now, the safety label has been updated and further research is occurring to ensure that this does not happen again in the future.

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