UK Authorization for Aflibercept
MHRA clears Eylea for macular edema following retinal vein occlusion
The UK's MHRA has approved aflibercept 8 mg (Eylea®) for treating visual impairment caused by retinal vein occlusion (RVO). This marks the third approval for the higher-dose formulation, supported by data from the Phase III QUASAR trial where aflibercept 8 mg demonstrated comparable visual acuity gains to the 2 mg dosage with fewer injections needed. By week 64, over 60% of patients in the 8 mg group had longer treatment intervals, indicating a significant reduction in treatment burden while achieving similar anatomical outcomes and maintaining a consistent safety profile.
1. Aflibercept 8 mg approved for retinal vein occlusion (RVO) in the UK. 2. Suitable for treating visual impairment from RVO. 3. Approval based on QUASAR trial data. 4. 8 mg group had fewer injections and similar visual outcomes as 2 mg. 5. Over 60% of patients in 8 mg achieved longer treatment intervals. 6. Safety profile consistent with previous studies. 7. Updated posology allows minimum 4-week treatment intervals.