Benzinga | May 3, 2021 07:35AM EDT

Novartis' Beovu Non-Inferior To Aflibercept In Phase 3 Diabetic Macular Edema Study

* Novartis AG (NYSE: 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 (NASDAQ: 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 280?m 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.