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Novartis: positive results for DME trial

( - Novartis has announced positive results from the first Phase III trial of Beovu versus aflibercept in patients with diabetic macular edema (DME).

"The trial met its primary and key secondary endpoints, demonstrating non-inferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52) ," Novartis said.

In a secondary endpoint, Beovu demonstrated greater improvement than aflibercept in change in central sub-field thickness (CST, a key indicator of fluid in the retina) over the period from week 40 to week 52.

Beovu demonstrated an overall safety profile that is well-tolerated comparable to aflibercept; in addition, the rate of intraocular inflammation was equivalent between Beovu and aflibercept.

“This data confirms our strong belief in Beovu as a potential therapy for DME patients, and if approved, will provide patients with a new treatment option to control their disease through better resolution of retinal fluid and CST reductions.” said Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology.

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