Bayer's Aflibercept 8mg Achieves First-Ever Sustained Vision Improvement in Diabetic Macular Edema with Extended Dosing Intervals

On July 3, Bayer announced the two-year (96-week) results of the pivotal clinical trial PHOTON, which investigated aflibercept 8mg for the treatment of diabetic macular edema (DME), extending the dosing interval up to 24 weeks, compared with the current standard treatment Eylea® (aflibercept 2mg) fixed 8-week dosing interval. The two-year results once again confirmed the long-term efficacy and safety of aflibercept 8mg in DME patients, as well as its unprecedented durability.

It was reported that at week 96, 89% of patients in the aflibercept 8mg group maintained a dosing interval of ≥12 weeks, compared to 93% at week 48. A significant number of DME patients met the criteria for extending the dosing interval to greater than every 16 weeks, with 43% achieving a dosing interval of ≥20 weeks and 27% reaching a 24-week dosing interval.

At baseline, patients randomly assigned to the 16-week dosing regimen maintained a ≥16-week dosing interval for two years in 83% of cases and sustained the 16-week dosing interval within one year in 89% of cases. The average number of injections for this group at week 96 was 7.8, compared to 13.8 injections with the fixed every-8-week regimen of Eylea® (aflibercept 2mg), reducing the number of injections by six over two years. Meanwhile, extending the treatment interval with aflibercept 8mg achieved consistent and sustained visual acuity benefits and safety comparable to the standard treatment of Eylea® (aflibercept 2mg).

Editor: Muyan

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