Beovu receives FDA approval for new indication in diabetic macular edema
The FDA approved Beovu for the treatment of diabetic macular edema, Novartis announced in a press release.
This new indication follows the previous approval of Beovu (brolucizumab, Novartis) 6 mg for wet age-related macular degeneration in 2019 and was based on 1-year data from the phase 3 KESTREL and KITE clinical trials comparing the efficacy and safety of brolucizumab with aflibercept.
According to Carl D. Regillo, MD, an investigator in both trials, Beovu is a “welcome addition to the current anti-VEGF treatment options in managing DME.”
“Having brolucizumab FDA approved for treating DME is good news for our patients,” he told Healio/OSN. “The phase 3 clinical trials showed better drying of the macula with brolucizumab compared to aflibercept and also the potential for increased durability, both of which may lead to improved visual outcomes for some patients with DME.”
In both trials, Beovu met the primary endpoint of noninferiority to aflibercept in best corrected visual acuity change from baseline and showed better capability to dry the macula from both intraretinal and subretinal fluid. A significant reduction in central subfield thickness starting at week 4 and continuing up to week 52 was reported.
In the loading phase, Beovu was administered every 6 weeks for a total of five doses, followed by treatment every 12 weeks. In case of disease activity, the interval was shortened to 8 weeks. Through year 1, 55% of Beovu patients in KESTREL and 50% of Beovu patients in KITE maintained a 12-week dosing interval. By week 52, patients received a median of seven Beovu injections.
According to the release, “Beovu may offer fewer injections from the start of treatment through year 1” as compared with other anti-VEGFs.
Intraocular inflammation rates in KESTREL were 3.7% for Beovu 6 mg, including 0.5% retinal vasculitis, and 0.5% for aflibercept. In KITE, intraocular inflammation rates were 1.7% for Beovu 6 mg and aflibercept, with no cases of retinal vasculitis. Retinal vascular occlusion occurred in 0.5% of the eyes treated with Beovu 6 mg vs. no eyes treated with aflibercept in KESTREL and in 0.6% of the eyes treated with either drug in KITE.
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