Novartis is confident that Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit/risk profile when used on an 8- to 12-week interval following 3 monthly loading doses.
Novartis is fully committed to keeping the retina community informed of the latest information pertaining to the safety of Beovu.
We would like to sincerely thank healthcare providers who have shared reports. You are encouraged to continue to report any observed or suspected adverse events according to local country requirements. You can also make a report to Novartis at https://www.report.novartis.com.
We will continue to provide regular updates on this website as new information becomes available.
An update on the Beovu clinical program: One-year first interpretable results from the MERLIN trial have been reported.
Novartis reported the first interpretable year one results of the Phase III MERLIN study, a two-year study initiated in H2 2018, assessing the efficacy and safety of Beovu® (brolucizumab) 6 mg versus aflibercept 2 mg given every four weeks following the loading phase in patients with wet age-related macular degeneration (AMD) who have persistent retinal fluid despite anti-VEGF therapy.
Beovu met MERLIN’s primary endpoint of non-inferiority in change in best corrected visual acuity from baseline at year one versus aflibercept when given every four weeks following the loading phase. However, given every four weeks in MERLIN, intraocular inflammation (IOI), including retinal vasculitis (RV) and retinal vascular occlusion (RO), were reported with a higher frequency in the Beovu 6 mg every four weeks arm when compared to aflibercept 2 mg every four weeks (IOI: 9.3% vs 4.5% of which RV: 0.8% vs 0.0%; RO: 2.0% vs 0.0%.). The overall rate of vision loss (15 letters or more) due to all causes was 4.8% in the Beovu arm and 1.7% in the aflibercept arm.
In the interest of patient safety, Novartis has decided to terminate the MERLIN study and the RAPTOR and RAVEN studies, which were assessing the efficacy and safety of brolucizumab with six initial monthly injections in retinal vein occlusion. All other relevant ongoing trial protocols will be amended to discontinue four-week dosing intervals after the loading phase.
Physicians should not treat patients with Beovu 6 mg at intervals less than two months beyond the first three monthly loading doses*.
When used on an 8- to 12-week interval following loading phase, Beovu continues to be an important and effective treatment option for appropriate patients with wet AMD.
Novartis has proactively communicated these data to health authorities and will continue to discuss respective updates to the Beovu prescribing information globally regarding every 4-week dosing.
*Please note, Beovu is not approved to treat retinal vascular occlusion (RO).
