Beovu meets endpoints in phase 3 DME study
Beovu met its key endpoints in a phase 3 study investigating safety and efficacy in the treatment of diabetic macular edema, according to a Novartis press release.
The KITE study demonstrated the noninferiority of Beovu (brolucizumab 6 mg) vs. aflibercept 2 mg in mean change in best corrected visual acuity at 1 year. In addition, Beovu demonstrated “superior” improvement vs. aflibercept in change of central subfield thickness from week 40 through week 52. The Beovu safety profile was comparable to aflibercept, with equivalent intraocular inflammation rates.
KITE is ongoing and will span 2 years. It enrolled 360 patients with DME at 80 centers in 23 countries. Novartis anticipates results from a second DME study, KESTREL, later this year.
“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,” Dirk Sauer, global head development, Novartis Pharma Ophthalmology, said in the release.
Beovu is approved in more than 40 countries for the treatment of wet age-related macular degeneration.
In a separate release, Novartis announced the European Medicines Agency approved a safety label update for Beovu in wet AMD treatment, including information regarding retinal vasculitis and retinal vascular occlusion. The label update is applicable to all European Union members, as well as the U.K., Norway and Liechtenstein. The FDA approved the U.S. label update in June.