Novartis have announced their European Commision Approval of Beovu, their treatment for Diabetic Macular Edema (DME). DME is a leading cause of vision loss in working-age people. In 2020, Beovu was granted European Commission Approval for the treatment of wet-age macular degeneration, making this newest announcement its second indication.
The European Commission granted their approval following year 1 data from the phase 3 KESTREL and KITE studies which met their primary endpoint of noninferiority in change in best corrected visual acuity from baseline vs aflibercept.
“This approval marks a significant milestone for DME patients, many of whom are of working age and struggle with adherence due to the need to manage multiple comorbidities related to diabetes” J. Jill Hopkins, MD, SVP and Global Development Unit Head of Ophthalmology for Novartis Pharmaceuticals.
Previously, Novartis came into difficulties with Beovu. They halted three trials over safety concerns due to high rates of inflammatory reactions in the #eyes. With the advent of the news around DME, it would seem these safety issues have been resolved, with Novartis stating that the majority of the adverse events from Beovu for DME’s KESTREL and KITE studies ‘were manageable and resolved with routine clinical care’.
Novartis’ application for Beovu for DME is also under review by the FDA and Japanese Pharmaceuticals and Medical Devices Agency.
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