Despite rigorous testing before pharmaceutical products are introduced to the market, some still present negative side effects. In a discussion on Beovu (brolucizumab), used to treat neovascular macular degeneration (AMD), Healio notes that the drug has been associated with ocular inflammation. As a result, patients are at increased risk of developing occlusive vasculitis and/or vision loss. To combat this, both Novartis and the American Society of Retina Specialists (ASRS) are conducting safety reviews.
Neovascular AMD
Neovascular macular degeneration (AMD) is an eye disease causing ocular damage and vision loss. The condition sits under the umbrella of macular degeneration, caused by a mix of environmental and genetic factors. Macular degeneration can either be dry (85-90% of diagnoses) or wet (10-15%). In the former, the macula (part of the retina) thins and degenerates. In the latter, abnormal blood vessels leak blood and fluid, causing ocular scarring. Overall, both wet and dry macular degeneration impair the ability to read, drive, see details, recognize colors, and other actions related to vision.
Wet AMD is also called neovascular AMD. According to Roche, neovascular AMD occurs when:
new and abnormal blood vessels grow uncontrollably under the macula, causing swelling, bleeding and/or fibrosis.
Generally, AMD affects patients over the age of 55. Additional risk factors include a family history of macular degeneration, smoking, and being Caucasian. Symptoms of neovascular AMD include:
- Vision loss
- Blind spots in your line of vision
- Decreased ability to see colors or recognize faces
- Difficulty adjusting to lower light levels
- Impaired ability to carry out daily tasks
Learn more about neovascular AMD here.
Safety Reviews
In 2019, Beovu, developed by Novartis, was approved for the treatment of neovascular AMD. The drug therapy inhibits vascular endothelial growth factor (VEGF). Anti-VEGF treatments slow blood vessel growth. According to the American Academy of Ophthalmology (AAO), anti-VEGF treatments improve vision in approximately 33% of patients.
However, shortly after its approval, patients began reporting ocular inflammation. While some patients experienced vasculitis (swelling of blood vessels), others did not. Concerned about the rate of ocular inflammation, both Novartis and the ASRS’ ReST Committee began analyzing the drug’s safety.
Ultimately, Novartis determined that the rate of inflammation attributed to Beovu is 4.6%, with only 2.1% developing vasculitis. Additionally, these adverse reactions can occur up to 18 months (1.5 years) following treatment, though symptoms related to vision loss usually appear within 6 months. Altogether, 1 in 200 patients using Beovu are at risk of losing up to 6 lines of vision.
Interested in safety updates? Check here for the newest Beovu-related information.
