Regeneron announces aflibercept 8mg injection meets primary endpoint in phase 3 QUASAR trial in patients with retinal vein occlusion

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Regeneron Pharmaceuticals has announced that the phase 3 QUASAR trial of EYLEA HD(aflibercept 8 mg) has met its primary endpoint.

QUASAR is a global, double-masked, active-controlled phase 3 trial evaluating the efficacy and safety of EYLEA HD, compared to EYLEA, in patients with retinal vein occlusion (RVO), including those with central, branch, and hemiretinal vein occlusions. In the trial, patients were treated with an 8-week dosing regimen of EYLEA HD, following 3 or 5 initial monthly doses, while EYLEA patients were treated every 4 weeks.

The primary endpoint of mean change in best corrected visual acuity (BCVA) from randomization through week 36, as measured by the Early Treatment Diabetic Retinopathy Study letter score, was met at 36 weeks in all patients receiving EYLEA HD compared to EYLEA. Furthermore, EYLEA HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions.¹

The mean observed BCVA improvement of patients treated with the EYLEA 4-week regimen (n=301) was 17.8 letters while the BCVA improvement of patients treated with EYLEA HD 8-week regimen after 3 initial monthly doses (n=293) and 5 initial monthly doses (n=298) was 17.0 and 19.1 respectively.¹ The mean observed BCVA for EYLEA was 72.0 letters, while EYLEA HD after 3 monthly doses and 5 initial monthly doses was 72.8 and 74.6 letters respectively.

Seenu M. Hariprasad, MD, Chair of the Department of Ophthalmology and Visual Science, The University of Chicago, commented on the results in a press release from Regeneron.

“All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing, which can be burdensome for a patient. These impressive data from QUASAR demonstrated that EYLEA HD patients with retinal vein occlusion experienced improved vision with fewer injections than EYLEA – which could offer a significant advancement in this treatment setting,” said Hariprasad. “Furthermore, about 90% of EYLEA HD patients were able to maintain 8-week dosing intervals through 36 weeks.”

According to the company, the safety profile of EYLEA HD (n=591) was similar to EYLEA (n=301) in QUASAR and remained “generally consistent” with the known safety profile of EYLEA HD in its pivotal trials.¹

George D. Yancopoulos, MD, PhD, Board co-chair, president, and Chief Scientific Officer at Regeneron stated in the release “EYLEA HD has already made a significant impact on the treatment of its three approved indications – wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy – and now has the potential to substantially reduce the treatment burden for patients with retinal vein occlusion. We look forward to sharing these results with regulatory authorities around the world as soon as possible.”

Regeneron stated the company plans to submit these data to the US Food and Drug Administration in the first quarter of 2025.¹

References:

1. EYLEA HD® (aflibercept) Injection 8 mg Phase 3 Trial Meets Primary Endpoint Showing Improved Vision with Extended Dosing Intervals in Patients with Macular Edema following Retinal Vein Occlusion. Press Release; December 17, 2024. Accessed December 17, 2024. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary