Novartis updates on uses and safety of Beovu in patients with wet AMD

US: Novartis has recently issued a press release informing about the use and safety of Beovu which is approved for the treatment of wet age-related macular degeneration (wet AMD) by the US Food & Drug Administration (FDA), the European Commission (EC), Swissmedic and the Australian Therapeutic Goods Association (TGA). The safety of Beovu has been demonstrated in an extensive Phase III program, including more than 1,800 patients worldwide across 400 study sites.

"As with all medicines, adverse events can occur, which is why we continuously monitor the safety of our products for the occurrence of such events. The prescribing information leaflet for Beovu in the US states a 4% rate of intraocular inflammation and a 1% rate of retinal artery occlusion. As of February 28, our global safety organization is conducting a comprehensive review of a limited number of reported cases of severe vision loss, inflammation and potential retinal vasculitis in patients treated with Beovu, including cases where patients had previously received other VEGF inhibitors. We believe the incidence of these events remains consistent with or below the package insert. In the registration trials, the incidence of vision loss was comparable at all letter intervals across Beovu and aflibercept." Novartis stated

"As part of our safety surveillance program, we are conducting a comprehensive product quality review and actively evaluating every case. We are working closely with the reporting physicians and retina specialists to collect the relevant clinical data and fully understand these events. Furthermore, we are engaging with the Data Monitoring Committee (DMC) for our ongoing global trials and have engaged an external Safety Review Committee (SRC) to further evaluate and advise on the post-marketing cases. The FDA, EMA, Swissmedic, Australian TGA and other health authorities are aware of our review, and we are in the process of informing other regulatory bodies. We commit to sharing the outcome of the review upon completion."Novartis stated 

While the review is ongoing and Novartis' classification of these reported adverse events has not yet been established, clinicians' reports suggest that most cases present after the first or second injection of Beovu with patients reporting changes in vision, such as significant increase in floaters or blurry vision, within one to two weeks of treatment.

Based on these preliminary observations and consistent with the approved Beovu product labelling, Novartis reminds physicians to advise patients that in the days following Beovu administration, if the eye becomes red, sensitive to light, painful or develops a change in vision, they should seek immediate care from an ophthalmologist.

Physicians are also reminded to act promptly when symptoms are reported by patients, and if clinical signs of intraocular inflammation or changes in vision after Beovu injection are observed, withhold Beovu, perform the appropriate diagnostic evaluation and treat the symptoms of intraocular inflammation as per good medical practice. 

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