Treatment With Bevacizumab Is Noninferior to Aflibercept in Terms of Visual Acuity, Researchers Say

Anti—vascular endothelial growth factor (anti-VEGF) therapy is the standard of care for the first-line treatment of macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, and a number of therapeutic options are available, including aflibercept, ranibizumab, and off-label bevacizumab.

Increasingly, off-label reference bevacizumab is becoming a treatment of choice in European nations due to its favorable cost effectiveness, and biosimilar options, expected to reduce costs even further, have been approved in Europe and the United States, though none have been launched. Rulings in the United Kingdom and in the European Union’s Court of Justice have upheld the practice of using bevacizumab instead of approved anti-VEGF options despite challenges from other drug makers whose products hold indications for the treatment of eye disorders.

Despite the lack of an indication for the drug, and given the interest in its cost-saving potential, investigations into bevacizumab’s utility in eye disorders continue worldwide. Recently, a secondary analysis of a randomized clinical trial in 346 US patients—the SCORE2 trial, main results of which were reported elsewhere—found that patient-reported visual function after treatment with bevacizumab was noninferior to that reported after treatment with aflibercept at 6 months.

In the SCORE2 trial, eyes were randomly assigned to receive an intravitreal injection of bevacizumab or aflibercept at baseline, then every 4 weeks through month 5. The primary outcome of the preplanned secondary analysis was the difference between the treatment arms at month 6 in the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ—25).

The investigators of the secondary analysis found that, significant improvements occurred from baseline to month 6 in NEI VFQ—25 composite score in the aflibercept group and the bevacizumab group. The mean change for the aflibercept group was 7.5 (standard error [SE], 7.5; P <.001) and 6.1 (SE, .09; P <.001) in the bevacizumab group.

At month 6, no differences were observed in NEI VFQ—25 composite or subscale scores between the groups.

These findings, write the investigators, are “remarkably consistent” with the primary outcome findings from the SCORE2 trial a month 6, which reported noninferiority of bevacizumab to aflibercept in visual acuity.

Reference

Scott IU, VanVeldhuisen PC, Barton F, et al. Patient-reported visual function outcomes after anti—vascular endothelial growth factor therapy for macular edema due to central retinal or hemiretinal vein occlusion: preplanned secondary analysis of a randomized clinical trial [published online June 6, 2019]. JAMA Ophthalmol. doi: doi:10.1001/jamaophthalmol.2019.1519.