The ASRS issued a note to its members about concerns regarding reports of vasculitis, an inflammation of the blood vessels and other complications that can lead to the loss of vision, as a potential side effect of treatment with Beovu.
Shares of Novartis took a 5% hit Monday after The American Society of Retinal Specialists (ASRS) raised concerns about the Swiss pharma giant’s recently approved wet age-related macular degeneration treatment Beovu.
Over the weekend, the ASRS issued a note to its members about concerns regarding reports of vasculitis, an inflammation of the blood vessels and other complications that can lead to the loss of vision, as a potential side effect of treatment with Beovu. ASRS pointed to 14 cases of vasculitis, 11 of which were designated as occlusive retinal vasculitis, which is an inflammatory condition that does threaten vision, the New York Times reported.
Following the concerns raised by the ASRS, Novartis said it will engage with an external safety review committee to evaluate the post-marketing cases reported by the retinal specialist society, the Times reported. Since its approval, there have been about 46,000 injections of Beovu administered in the United States. The U.S. Food and Drug Administration is aware of the company’s review and Novartis is reporting the incidents to other regulatory agencies around the globe, the Times added.
“Our clinical development and pharmacovigilance teams are working with healthcare professionals to quickly obtain and evaluate all available information in order to classify these events and identify potential risk factors,” Novartis said in a statement to the Times.
In a note issued to clients on Monday, Piper Sandler analyst Christopher Raymond said the ASRS concerns would lead to many treating physicians to “freak out” about the side effects of the drug. Raymond added that the bad news for Novartis is good news for Regeneron and its eye treatment, Eylea, Seeking Alpha reported.
Beovu was approved by the FDA in October for the treatment of wet AMD after clinical data showed that Novartis’ drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity (BCVA) at 48 weeks. In both clinical trials, approximately 30% of patients gained at least 15 letters at that time, the company said. During clinical testing, Beovu hit a number of endpoints, including vision gains that were non-inferior to Eylea at one year, with longer treatment intervals in a majority of patients. Beovu also demonstrated greater reductions in central subfield thickness, which is a key indicator of fluid in the retina as early as 16 weeks after induction. At one year, the reduction was greater than Eylea, Novartis added.
Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision. Fluid that leaks out of these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula. It is estimated that about 1.75 million people in the United States will be living with wet AMD and about 20 million people around the world.