Aflibercept 8 mg Maintains Long-Term Visual Improvement in Diabetic Macular Edema

Aflibercept 8mg maintains long-term visual and anatomic improvements at extended dosing intervals in patients with diabetic macular edema (DME), according to a recent study presented at the 43^rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA.¹

Presented by Eric Schneider, MD, Tennessee Retina, this study evaluated the results of the optional 1-year PHOTON extension study. The original PHOTON study was a double-masked, active-controlled pivotal trial aiming to determine the non-inferiority of aflibercept 8mg 12-week (8q12; n = 328) and 16-week (8q16; n = 163) dosing regimens after 3 initial monthly doses compared against an 8-week dosing regimen for aflibercept 2mg injections (2q8; n = 167) after 5 initial monthly doses.^1,2

At the 2-year endpoint of the study, the 8q16 group displayed a substantially lower mean number of injections (7.8 versus 9.5 in 8q12 and 13.8 in 2q8), as well as a significantly lower percentage of patients losing ≥15 letters (1.2% versus 3.4% and 3.6%). However, patients in the 8q16 group also displayed a lower score in mean observed best-corrected visual acuity (BCVA) improvement (7.5 letters versus 8.8 and 8.4) and mean change from baseline (6.6 letters versus 8.2 and 7.7).²

A collective 93% of patients in the combined aflibercept 8mg group had a last assigned dosing interval of ≥12 weeks at week 96. To further assess efficacy, durability, and safety of treatment, this optional extension to 156 weeks evaluated long-term treatment outcomes in both patient groups.¹

After week 96, Schneider and colleagues continued to give patients randomized to 8q12 or 8q16 aflibercept 8mg (8mg group; n = 195), while those randomized to 2q8 were switched to aflibercept 8mg and assigned 12-week dosing intervals (2q8-8mg group; n = 70). From week 100, investigators could shorten dosing intervals at any visit or extend them at dosing intervals, provided prespecified criteria were met.¹

Investigators noted that, at week 156, both the 8mg and 2q8-8mg groups maintained the visual and anatomic improvements that were shown at week 96. The 2q8-8mg group displayed a significantly slower fluid reaccumulation rate 8 weeks after the first aflibercept 8mg injection compared with 8 weeks after aflibercept 2mg injections during the first 2 years of the study.¹

Of the patients in the 8mg group who completed the extension, 45% and 48% had a last completed and last assigned dosing interval of ≥20 weeks, respectively. Through week 156, a collective 83% of patients in the 2q8-8mg group had a last assigned dosing interval of ≥12 weeks. Investigators found no new safety signals through the termination of the extension.¹

“The achievement of extended dosing intervals with aflibercept 8mg in the vast majority of patients, together with the slower fluid reaccumulation observed following a switch from aflibercept 2mg to 8mg, supports the longer duration of action of aflibercept 8mg versus 2mg,” Schneider and colleagues wrote.¹

References

1. Schneider E. Aflibercept 8 mg in Diabetic Macular Edema: 156-Week Results from the PHOTON Extension Study. Abstract presented at the 43^rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, July 30-August 2, 2025.

2. Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema. Regeneron. June 27, 2023. Accessed July 31, 2025. https://investor.regeneron.com/news-releases/news-release-details/two-year-results-aflibercept-8-mg-pivotal-photon-trial