logo
Plus   Neg
Share
Email

Novartis: Beovu Trial Shows Positive Topline Results In DME Patients

Swiss drug major Novartis (NVS) Monday announced positive topline results from the first Phase III trial of Beovu versus aflibercept in patients with diabetic macular edema or DME.

DME is the leading cause of blindness in people with diabetes and affects 21 million people across the world.

In Phase III KITE study, Beovu (brolucizumab) 6 mg achieved its primary endpoint of non-inferiority to aflibercept 2 mg in mean change in best-corrected visual acuity or BCVA at year one (week 52).

The trial met its key secondary endpoint too. Beovu showed superior improvement versus aflibercept in change of central subfield thickness, a secondary endpoint.

In KITE, Beovu demonstrated an overall well-tolerated safety profile comparable to aflibercept.

The KITE pivotal trial is an ongoing two-year study that enrolled 360 patients with DME across 80 centers in 23 countries.

The company will submit the data from KITE for presentation at medical congresses and for peer-review publication.

Novartis is currently conducting a second study in DME, KESTREL, and anticipates results later in the year, when Novartis will assess next steps with health authorities.

Beovu (brolucizumab, also known as RTH258) is approved in more than 40 countries for the treatment of wet age-related macular degeneration or AMD.

Additional trials are currently ongoing which study the effects of brolucizumab in patients with AMD, diabetic macular edema, retinal vein occlusion and proliferative diabetic retinopathy.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT