Second phase 3 study shows good results for Beovu in DME treatment
Patients with diabetic macular edema treated with brolucizumab 6 mg demonstrated noninferiority in change in best corrected visual acuity compared with patients who received aflibercept 2 mg, according to the results of a phase 3 study.
Novartis released data from the phase 3 KESTREL study, which assessed the safety and efficacy of Beovu (brolucizumab) 3 mg and 6 mg in DME. Patients in the brolucizumab 6 mg arm experienced noninferiority in change in BCVA at 1 year from baseline compared with patients treated with 2 mg of aflibercept. In addition, the study reached its secondary endpoint of noninferiority in average change in BCVA for brolucizumab 6 mg compared with aflibercept 2 mg from week 40 to week 52.
KESTREL is the second pivotal phase 3 study of brolucizumab in DME following the KITE study, which demonstrated the noninferiority of brolucizumab vs. aflibercept 2 mg in mean change in BCVA at 1 year.
“Approximately 25% of DME patients switch from their initial therapy due to poor treatment outcomes, and that treatment adherence drops after 1 year. The data from KITE and KESTREL suggest Beovu may have the potential to provide DME patients with better disease management through extended dosing intervals, which could ultimately lead to better adherence,” Dirk Sauer, global head development, Novartis Pharma Ophthalmology, told Healio/OSN.
Patients treated with brolucizumab 6 mg experienced significant improvement in change of central subfield thickness from baseline over the period of week 40 through 52. Brolucizumab also had a well-tolerated safety profile, according to the release.
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