Clinical Report: UK Authorization for Aflibercept 8 mg

Overview

The UK MHRA has authorized aflibercept 8 mg for treating visual impairment due to macular edema secondary to retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion.

Background

Aflibercept is an anti-VEGF therapy that has become a standard treatment for macular edema secondary to RVO, including branch, central, and hemiretinal vein occlusion. The introduction of a higher-dose formulation aims to reduce the treatment burden on patients while maintaining visual outcomes. This is particularly significant given the increasing demand for retinal services in the UK.

Data Highlights

Key Findings

• Aflibercept 8 mg met its primary endpoint at week 36 in the QUASAR trial.
• It demonstrated non-inferior visual acuity gains compared to aflibercept 2 mg.
• Patients receiving aflibercept 8 mg required fewer injections over time.
• More than 60% of patients in the 8 mg arm achieved treatment intervals of four months or longer.
• Fluid reduction and anatomical outcomes were comparable to the 2 mg regimen.
• The safety profile of aflibercept 8 mg was consistent with previous studies.

Clinical Implications

The authorization of aflibercept 8 mg provides clinicians with a new option that may reduce the frequency of injections required for patients with RVO, potentially alleviating some of the pressure on healthcare services while maintaining effective visual outcomes.

Conclusion

The approval of aflibercept 8 mg represents a significant advancement in the management of RVO, offering a higher-dose option that enhances treatment flexibility and patient convenience.

References

1. Bayer, PharmiWeb.com, 2026 -- Bayer receives MHRA authorisation for third retinal indication of Eylea® (aflibercept 8 mg) for treatment of retinal vein occlusion
2. Regeneron Pharmaceuticals Inc., Investor.Regeneron.com, 2025 -- 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
3. Retinal Physician, 2025 -- Aflibercept 8 mg Meets Primary Endpoint in QUASAR
4. Ophthalmology Management, 2025 -- CMS Establishes New QCode for Aflibercept Biosimilar Yesafili
5. Guideline Central, 2025 -- AAO Retinal Vein Occlusions Guideline Summary
6. retinal physician — Aflibercept 8 mg Meets Primary Endpoint in QUASAR
7. retinal physician — IRIS Registry Analysis Shows Vision Gains With Aflibercept 8 mg
8. AAO Retinal Vein Occlusions Guideline Summary - Guideline Central
9. 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 | Regeneron Pharmaceuticals Inc.
10. Bayer receives MHRA authorisation for third retinal indication of Eylea® (aflibercept 8 mg) for treatment of retinal vein occlusion - PharmiWeb.com