Novartis' Beovu Non-Inferior To Aflibercept In Phase 3 Diabetic Macular Edema Study - Novartis (NYSE:NVS), Regeneron Pharmaceuticals (NASDAQ:REGN)

Novartis AG NVS has reported that its Beovu (brolucizumab) drug met primary endpoints in Phase 3 KESTREL and KITE trials conducted in diabetic macular edema (DME) patients.
According to one-year data, 6mg Beovu showed non-inferiority in change in best-corrected visual acuity from baseline compared to 2mg Regeneron Pharmaceuticals Inc's REGN Eylea (aflibercept).
In the KESTREL study, patients in the Beovu arm demonstrated a mean of 9.2 letters against 10.5 letters for those on aflibercept. Meanwhile, in the KITE trial, Beovu showed a mean of 10.6 letters compared to 9.4 letters with aflibercept.
For secondary endpoints, data revealed intraretinal and subretinal fluid at weeks 32 and 52 in fewer eyes treated with Beovu versus those on aflibercept.
The company added that central subfield thickness (CSFT) levels below 280μm were found at weeks 32 and 52 in more eyes treated with Beovu versus eyes treated with aflibercept.
Fluid is considered a vital disease activity marker in DME, while CSFT is a crucial fluid marker in the retina.
Novartis said that these trial data might enable fewer injections of Beovu.
Results showed Beovu was overall well-tolerated in both trials. The most common ocular and non-ocular adverse events reported were conjunctival hemorrhage, nasopharyngitis, and hypertension.
Novartis plans to submit these one-year results to regulatory authorities in the first half of this year.
Two-year results from KESTREL and KITE are expected to be available later this year.
Price Action: NVS shares are up 0.99% at $86.08 in the premarket session on the last check Monday.

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