Apr 7, 2022

Novartis: European Commission approves brolucizumab 6 mg for patients with diabetic macular edema

David Hutton, OT Staff Reports
Approval is based on year 1 data from the Phase III KESTREL and KITE trials investigating brolucizumab 6 mg versus aflibercept 2 mg in DME patients.

Novartis this week announced that the European Commission (EC) has approved brolucizumab 6 mg (Beovu) for the treatment of visual impairment due to diabetic macular edema (DME).

The approval in DME represents the second indication for Beovu granted by the EC, which was first approved for the treatment of wet age-related macular degeneration in 2020.3 The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway and Liechtenstein.

The EC approval was based on year one data from the Phase III, randomly assigned, double-masked KESTREL and KITE studies, which met their primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at year one.2 In both trials,2 following the loading phase, over half of patients (55.1% in KESTREL and 50.3% in KITE) in the Beovu 6 mg arm remained on a 12-week dosing interval through year 12. Aflibercept dosing was aligned to the approved EU label in year 1 of treatment.2,4 In aggregate, a numerically lower proportion of patient eyes treated with Beovu had intraretinal fluid, subretinal fluid, or both at week 52 versus eyes treated with aflibercept (in KESTREL 60.3% in Beovu arm versus 73.3% in aflibercept arm; in KITE 54.2% versus 72.9%, respectively; testing for statistical significance was not performed.)2

Per the approved prescribing information, following the loading phase of five doses injected 6 weeks apart, physicians may individualize treatment for DME patients based on their disease activity, as assessed by vision and fluid-related parameters3. In patients without disease activity, physicians should consider 12-week intervals between Beovu treatments; in patients with disease activity, physicians should consider 8-week intervals between treatments.3

Read more: https://www.ophthalmologytimes.com/view/novartis-european-commission-approves-brolucizumab-6-mg-for-patients-with-diabetic-macular-edema?utm_source=sfmc&utm_medium=email&utm_campaign=04072022_OT_ALC-22-OPD0420_WEA-22-OPD0434_ARV-22-OPD0455_ENL_Alcon%20TRC_Weave_ARVO%20Text%20Ad%20-%20US&eKey=ZG9ubmFAbWFjdWxhcmhvcGUub3Jn

Source: Ophthalmology Times

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