To report the UK MHRA's marketing authorization for aflibercept 8 mg for treating visual impairment due to retinal vein occlusion (RVO), including branch, central, and hemiretinal vein occlusion.
Approach:
Key Findings:
Aflibercept 8 mg met its primary endpoint at week 36, showing non-inferior visual acuity gains compared to aflibercept 2 mg administered monthly.
Patients receiving 8 mg after three initial monthly injections required an average of 8.4 injections versus 11.7 in the 2 mg arm by week 64.
Over 60% of patients in the 8 mg group achieved treatment intervals of four months or longer at week 64, with 40% reaching five-month intervals.
Fluid reduction and anatomical outcomes were comparable between the 8 mg and 2 mg regimens.
The safety profile of aflibercept 8 mg was consistent with previous studies.
Interpretation:
The authorization of aflibercept 8 mg provides a higher-dose anti-VEGF option that may reduce the injection burden while maintaining visual outcomes for RVO patients, a significant consideration for NHS services.
Limitations:
The study focused on treatment-naïve patients, which may limit generalizability to all RVO patients.
Long-term outcomes beyond 64 weeks were not reported.
Conclusion:
The introduction of aflibercept 8 mg is a significant advancement in RVO treatment, likely to alleviate pressure on NHS retinal services.
