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August 18, 2021

Novartis reports positive data from Phase III DME trials of Beovu

Beovu showed a generally well-tolerated safety profile in Phase III KITE and KINGFISHER trials.

Novartis has reported positive data from two Phase III clinical trials of Beovu (brolucizumab) for diabetic macular oedema (DME), a common microvascular complication in diabetes patients.

The two trials, namely KITE and KINGFISHER, are international, randomised, double-masked, two-year trials that are analysing the safety and efficacy of 6mg Beovu against 2mg aflibercept in DME patients.

Year two of the pivotal KITE trial assessed Beovu on up to 16-week dosing intervals and the one-year KINGFISHER trial analysed the drug given every four weeks.

According to the findings, both trials showed an overall well-tolerated safety profile.

Furthermore, results from year two, or week 100, of the KITE trial revealed that most of the subjects who completed a preliminary 12-week cycle after the loading phase were sustained on a 12-week or 16-week dosing interval through the end of the trial.

As reported earlier, KITE met its primary goal of non-inferiority to aflibercept in best-corrected visual acuity (BCVA) from baseline at week 52, or year one.

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Beovu offered increased reductions in central subfield thickness (CSFT) and the number of eyes having intraretinal fluid and/or subretinal fluid (IRF/SRF) compared with aflibercept at year one.

CSFT and IRF/ SRF were the main fluid-related secondary goals of the trial.

Novartis noted that the year two data is in line with year one findings.

In the KITE trial, intraocular inflammation (IOI) rates were 2.2% in the Beovu arm as against 1.7% in the aflibercept arm, without any retinal vasculitis observed in both arms.

The Phase III KINGFISHER trial met the primary goal of non-inferiority to aflibercept in BCVA change from baseline at year one.

In addition, Beovu was superior to aflibercept in fluid-related secondary goals such as CSFT and IRF/SRF at year one.

Novartis Pharmaceuticals Ophthalmology Global Development Unit head Jill Hopkins said: “The year two KITE results reaffirm that Beovu may meet an important need to extend dosing intervals for patients with diabetic macular oedema, who are often overburdened with medical appointments.

“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.”

Year two data read out from the Phase III KESTREL trial of Beovu in DME is anticipated in the fourth quarter of this year.

In May 2021, Novartis decided to terminate the two-year Phase III MERLIN trial of Beovu in wet age-related macular degeneration patients despite meeting the primary endpoint.

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