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The company shared data from its two-year Phase III KITE trial and the one-year phase III KINGFISHER trial.
Novartis on Tuesday shared two-year brolucizumab 6 mg (Beovu) data from the two-year Phase 3 KITE trial and the one-year phase 3 KINGFISHER trial.
In its release, the company noted that a majority of patients who successfully completed an initial 12-week cycle following the loading phase in the KITE trial were maintained on a 12- or 16-week dosing interval through year two.
The company also noted that both trials demonstrated an overall well-tolerated safety profile.
Supported by findings from KESTREL and KITE, Novartis announced it has submitted its applications for Beovu in DME to both the FDA and the EMA.
The phase 3 KITE study examined brolucizumab 6 mg versus aflibercept for patients with diabetic macular edema (DME). In that study, brolucizumab demonstrated an overall well-tolerated safety profile comparable to aflibercept. In addition, the rate of intraocular inflammation was equivalent between brolucizumab and aflibercept.
In its KESTREL study, Novartis is evaluating brolucizumab in the DME indication.
The KINGFISHER study is evaluating the efficacy and safety of brolucizumab versus aflibercept in the treatment of patients with visual impairment due to DME.