Regeneron Pharmaceuticals (REGN) has announced positive results from its Phase 3 QUASAR trial evaluating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of macular edema following retinal vein occlusion (RVO). The trial demonstrated non-inferior vision gains with EYLEA HD dosed every 8 weeks compared to EYLEA® 2 mg dosed every 4 weeks, potentially reducing injection frequency by 50% for patients.
Table of Contents:
QUASAR Trial: A Breakthrough for RVO Treatment
Extended Dosing: A Game Changer for Patients
Safety Profile: Consistent with Previous Findings
Regulatory Pathway: FDA Submission in Q1 2025
Market Impact: Strengthening Regeneron’s Ophthalmology Franchise
The Science Behind EYLEA HD®: Targeting VEGF
Understanding RVO: A Common Cause of Vision Loss
Conclusion: A New Era in RVO Management
QUASAR Trial: A Breakthrough for RVO Treatment
The Phase 3 QUASAR trial met its primary endpoint, demonstrating that EYLEA HD patients dosed every 8 weeks achieved non-inferior visual acuity gains compared to EYLEA 2 mg dosed every 4 weeks. This finding suggests that EYLEA HD could offer a less frequent dosing regimen without compromising treatment effectiveness.
Extended Dosing: A Game Changer for Patients
A key benefit highlighted in the trial was the high patient retention rate on the extended dosing schedule. 88% of patients maintained an 8-week dosing interval after 3 initial monthly doses, and 93% maintained this schedule after 5 initial monthly doses. This reduced treatment burden could significantly improve patient adherence and real-world outcomes.
Safety Profile: Consistent with Previous Findings
The safety profile of EYLEA HD in the QUASAR trial was consistent with previous trials. While some ocular adverse events were reported (including a 5% incidence of increased ocular pressure, and rare cases of endophthalmitis and retinal vasculitis), the overall safety profile was deemed similar to EYLEA.
Regulatory Pathway: FDA Submission in Q1 2025
Regeneron plans to submit a supplemental Biologics License Application (sBLA) to the FDA in the first quarter of 2025 based on the QUASAR trial results. This submission could pave the way for potential approval of EYLEA HD for this indication, making it available to patients.
Market Impact: Strengthening Regeneron’s Ophthalmology Franchise
The positive QUASAR trial results could significantly strengthen Regeneron’s ophthalmology franchise, particularly in the competitive retinal disease market. The reduced injection frequency offered by EYLEA HD could provide a compelling competitive advantage.
The Science Behind EYLEA HD®: Targeting VEGF
Both EYLEA and EYLEA HD target vascular endothelial growth factor (VEGF), a protein that contributes to vascular leakage and macular edema in RVO. By inhibiting VEGF, these treatments help reduce fluid buildup and improve vision. EYLEA HD offers a higher dose of aflibercept, potentially allowing for less frequent injections.
Understanding RVO: A Common Cause of Vision Loss
Retinal vein occlusion (RVO) is the second most common retinal vascular disease and a leading cause of vision loss. It occurs when a vein in the retina is blocked, leading to blood buildup and potential macular edema.
Conclusion: A New Era in RVO Management
The positive results from the QUASAR trial offer new hope for patients with macular edema following RVO. EYLEA HD’s potential for less frequent dosing while maintaining vision gains could significantly improve treatment adherence and quality of life for those affected by this debilitating condition.