Novartis is conducting a comprehensive product quality review 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.
According to a Novartis statement to Healio/OSN on Feb. 25, the ASRS sent an update on Beovu (brolucizumab-dbll) to its members about reports of 14 cases of vasculitis in patients treated with the drug since its approval by the FDA in October 2019.
As of Feb. 28, the company’s global safety organization is conducting a review of reported cases of severe vision loss, inflammation and potential retinal vasculitis in patients treated with the drug, including cases in which patients had previously received other VEGF inhibitors. According to Novartis in a press release, the prescribing information leaflet for Beovu in the U.S. says there is a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion. The company believes the incidence of the events is consistent with or below the package insert.
Based on reports from clinicians, patients are presenting after the first or second Beovu injection with changes in vision, such as a significant increase in floaters or blurry vision, within 1 to 2 weeks of treatment, the release said. Physicians should advise patients that if the eye becomes red, sensitive to light or painful or develops a change in vision in the days after Beovu administration, they should seek immediate care from an ophthalmologist.
As of March 2, more than 57,000 Beovu vials have been shipped to physicians in the United States. According to the company, the safety of the drug has been demonstrated in a phase 3 program, which included more than 1,800 patients worldwide across 400 study sites.