Regeneron Pharmaceuticals and Bayer AG's Eylea HD (aflibercept 8 mg) has shown positive results in a Phase 3 clinical trial for patients with macular edema following retinal vein occlusion (RVO). The QUASAR trial demonstrated that Eylea HD, administered every eight weeks, achieved non-inferior visual acuity gains compared to the standard Eylea (aflibercept 2 mg) treatment, which requires injections every four weeks. This could significantly reduce the treatment burden for patients with RVO, a leading cause of vision loss.
The QUASAR trial, a global, double-masked, active-controlled study, involved patients with central, branch, and hemiretinal vein occlusions. Patients were randomized to receive Eylea HD every 8 weeks after 3 or 5 initial monthly doses, or Eylea every 4 weeks. The primary endpoint was the mean change in best corrected visual acuity (BCVA) from randomization through week 36, as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
Key Findings from the QUASAR Trial
The study met its primary endpoint, with Eylea HD demonstrating non-inferior visual acuity gains compared to Eylea. Specifically, patients treated with Eylea HD every 8 weeks achieved comparable improvements in vision to those treated with Eylea every 4 weeks. According to Regeneron, Eylea HD results were consistent across patients with branch retinal vein occlusions, and those with central retinal or hemiretinal vein occlusions.
Furthermore, the data indicated that a significant proportion of patients treated with Eylea HD were able to maintain an 8-week dosing regimen. 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.
Safety Profile
The safety profile of Eylea HD was similar to that of Eylea in the QUASAR trial. Ocular treatment-emergent adverse events (TEAEs) occurring in ≥5% of all Eylea HD patients included increased ocular pressure (5%). The rate of intraocular inflammation was 0.5% for Eylea HD and 1.3% for Eylea.
Implications for RVO Treatment
Retinal vein occlusion is a common cause of vision loss, affecting over 28 million people worldwide. Current treatment paradigms often involve frequent intravitreal injections, which can be burdensome for patients. The QUASAR trial results suggest that Eylea HD could offer a less frequent treatment option without compromising efficacy.
Seenu M. Hariprasad, M.D., Chair of the Department of Ophthalmology and Visual Science, The University of Chicago, noted, "Based on these new data, aflibercept 8 mg may offer the potential to halve the number of injections needed, as compared to standard-of-care aflibercept 2 mg and other anti-VEGF therapies."
Regulatory Plans
Regeneron plans to submit these data to regulatory authorities around the world, with a submission to the U.S. Food and Drug Administration (FDA) planned for the first quarter of 2025. If approved, Eylea HD could provide a valuable new option for managing macular edema following RVO with a reduced treatment burden.
