Representatives from Novartis stood behind the safety and efficacy of Beovu, a treatment for wet age-related macular degeneration, after the American Society of Retina Specialists shared an update with its membership on possible side effects of the therapy.
The American Society of Retina Specialists (ASRS) only shared the update with its members, but according to a Novartis statement sent to Healio/OSN, the update discussed reports of 14 cases of vasculitis in patients treated with Beovu (brolucizumab-dbll) since the therapy’s FDA approval in October 2019.
The ASRS update noted 11 of the 14 cases were designated by the reporting provider as occlusive retinal vasculitis, according to the Novartis statement.
“Novartis stands behind the safety and efficacy of Beovu. In addition to our own internal assessment, we have engaged an external safety review committee (SRC) to further evaluate these post-marketing cases. We will continue to share details as they become available,” Novartis representatives wrote in the company statement.
According to the company, since its approval an estimated 46,000 injections of Beovu have been administered in the United States as of Feb. 21, 2020. The FDA is aware of the company’s ongoing review and the company is in the process of informing other health authorities.- by Robert Linnehan
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