09.14.20

Novartis Reports Topline Results From the First Phase 3 Trial of Beovu Versus Aflibercept in DME Patients

Source: Novartis

Novartis reported the first interpretable results of the phase 3 KITE study, assessing the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema (DME). The trial met its primary and key secondary endpoints, demonstrating noninferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year 1 (week 52).1

In a secondary endpoint, Beovu demonstrated superior improvement versus aflibercept in change of central subfield thickness (CST, a key indicator of fluid in the retina) over the period of week 40 through week 52.1 More than half of patients in the Beovu arm were maintained on a 3-month dosing interval through year 1, following the loading phase. All aflibercept patients were on a 2-month dosing interval after the loading phase.1 In KITE, Beovu demonstrated an overall well-tolerated safety profile comparable to aflibercept.1 In addition, the rate of intraocular inflammation was equivalent between Beovu and aflibercept.1

“Living with DME has significant impact on patients’ lives and frequent treatment injections are needed to control the increased fluid in the eye,” Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology, said in a company news release. “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.”

The KITE pivotal trial is an ongoing 2-year study that enrolled 360 patients with DME across 80 centers in 23 countries.1 The data from KITE will be submitted for presentation at medical congresses and for peer-review publication. Novartis is currently conducting a second study in DME, KESTREL,2 and anticipates results later in the year, when Novartis will assess next steps with health authorities.

Novartis is actively progressing studies across wet age-related macular degeneration (AMD), DME, retinal vein occlusion, and proliferative diabetic retinopathy. The favorable benefit-risk of the Beovu development program was supported by a company-requested review of ongoing studies by the FDA.

Novartis has a comprehensive program of work underway to help support retina specialists with the latest data and understanding they need to make appropriate treatment decisions for their wet AMD patients. Beovu is currently approved in over 40 countries for the treatment of wet AMD.

References

  1. Novartis data on file. September 2020.
  2. ClinicalTrials.gov. Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL). https://clinicaltrials.gov/ct2/show/NCT03481634. Accessed September 2020.

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