gms | German Medical Science

Purpose: In the 96-week PHOTON study (NCT04429503), aflibercept 8 mg every 12 and 16 weeks (8q12 and 8q16) after 3 monthly doses demonstrated comparable visual and anatomic improvements to aflibercept 2 mg every 8 weeks (2q8) after 5 monthly doses in patients with diabetic macular edema; 93% of patients in the combined aflibercept 8-mg group had a last assigned dosing interval of ≥12 weeks at Week 96. An optional one-year extension (to 156 weeks) evaluated long-term treatment outcomes in patients who continued with aflibercept 8 mg and in those who were switched from aflibercept 2q8 to 8 mg.

Methods: Following Week 96, patients initially randomized to 8q12 or 8q16 continued to receive aflibercept 8 mg (8mg group; n=195), while patients initially randomized to 2q8 were switched to aflibercept 8 mg and assigned to 12-week dosing intervals (2q8à8mg group; n=70). From Week 100, dosing intervals could have been shortened at any visit or extended at dosing visits if prespecified criteria were met.

Results: At Week 156, both the 8mg and 2q8à8mg groups maintained the visual and anatomic improvements that were achieved at Week 96. In the 2q8→8 mg group, fluid reaccumulation was substantially slower 8 weeks after the first aflibercept 8-mg injection compared with 8 weeks after the aflibercept 2-mg injections these patients received through Week 88. Of patients in the 8 mg group who completed Week 156, 45% had a last completed dosing interval of ≥20 weeks, and 48% had a last assigned dosing interval of ≥20 weeks. Through Week 156, 83% of patients in the 2q8à8mg group had a last assigned dosing interval of ≥12 weeks. No new safety signals were identified through Week 156.

Conclusions: Long-term visual and anatomic improvements were maintained with aflibercept 8 mg at extended dosing intervals, with no new safety signals through 156 weeks. The achievement of extended dosing intervals with aflibercept 8 mg in the vast majority of patients, together with the slower fluid reaccumulation observed following a switch from aflibercept 2 mg to 8 mg, supports the longer duration of action of aflibercept 8 mg versus 2 mg.

This abstract has been recently submitted and will be presented at the 2025 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).