By Martin David Harp
Results were published from the phase 3 QUASAR trial and the extension study of the phase 3 PULSAR trial.
Regeneron Pharmaceuticals has announced results from the phase 3 QUASAR trial and its extension study of the phase 3 PULSAR trial investigating EYLEA HD (aflibercept) Injection 8 mg.
The QUASAR trial a global double-masked, active-controlled Phase 3 trial evaluating the efficacy and safety of EYLEA HD in patients with macular edema secondary to RVO, including those with central retinal vein occlusion, branch retinal vein occlusion, or hemiretinal vein occlusion. In the trial, patients were randomized into 3 groups to receive either: EYLEA HD every 8 weeks following 3 initial monthly doses; EYLEA HD every 8 weeks following 5 initial monthly doses; or EYLEA every 4 weeks. The primary endpoint was mean change in BCVA from randomization through week 36.1
Results from the QUASAR trial1 showed that it met its primary endpoint at 36 weeks, with both groups of EYLEA HD patients dosed every 8 weeks achieving non-inferior visual acuity gains compared to those receiving EYLEA (aflibercept) Injection 2 mg dosed every 4 weeks. Furthermore, the company noted EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions. Of the patients treated with EYLEA HD through 36 weeks, 88% of patients were able to sustain an 8-week dosing regimen following 3 initial monthly doses, and 93% of patients maintained an 8-week dosing regimen after completing 5 initial monthly doses.
The safety profile of EYLEA HD in the QUASAR trial was similar to EYLEA and remained generally consistent with the known safety profile of EYLEA HD in its pivotal trials, according to the company.
Source: Modern Retina