Positive results reported for Beovu in phase 3 DME trials
Two phase 3 clinical trials evaluating Beovu in patients with diabetic macular edema had positive visual acuity results with a well-tolerated safety profile, according to a press release from Novartis.
Beovu (brolucizumab) 6 mg was assessed against aflibercept 2 mg in both trials.
In the KITE trial at 2 years, a majority of patients who successfully completed an initial 12-week cycle after a loading phase were maintained on a 12- or 16-week dosing interval. Results for Beovu were consistent with those seen at 1 year, with maintenance of best corrected visual acuity and greater reductions in central subfield thickness and the number of eyes with intraretinal and/or subretinal fluid vs. aflibercept.
In the KINGFISHER trial, Beovu met the primary endpoint of noninferiority to aflibercept in change in BCVA from baseline to 1 year with dosing every 4 weeks.
The most common adverse events in the KITE trial were cataract and dry eye. Among patients who received Beovu, 2.2% experienced intraocular inflammation compared with 1.7% who received aflibercept. Retinal vascular occlusion rates were 0.6% for both Beovu and aflibercept. No retinal vasculitis was reported in either arm.
In the KINGFISHER trial, the most common adverse events were COVID-19 and hypertension. Intraocular inflammation rates were 4% for Beovu and 2.9% for aflibercept, while the retinal vasculitis rates were 0.9% and 0.6%, respectively. Retinal vascular occlusion was reported in 0.3% of the Beovu arm and 0.6% of the aflibercept arm.
“Along with the top-line results from KINGFISHER, the KITE findings add to the growing body of data supporting our understanding of where Beovu may potentially fit into the DME treatment landscape,” Jill Hopkins, global development unit head, ophthalmology, Novartis, said in the release. “We look forward to continuing discussions with global health authorities about the findings from the KESTREL and KITE clinical trials, and we will continue to assess the clinical relevance of the positive KINGFISHER findings.”
Read more about