Jordana Fein, MD: Pre-Dose IOP Outcomes After Aflibercept 8 mg for DME

Pre-dose intraocular pressure (IOP) outcomes in eyes with diabetic macular edema (DME) treated with intravitreal aflibercept 8 mg were comparable to the 2 mg dose, according to a post hoc analysis of the Phase 2/3 PHOTON trial.

These data, presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, showed minimal changes from baseline across Week 48 in patients receiving aflibercept 8 mg every 12 weeks (Q12W) or every 16 weeks (Q16W) or the 2 mg dosed every 8 weeks (Q8W).

“Essentially, through Week 48, the mean change in pre-dose IOP from baseline did not exceed ±1 mmHg in study eyes receiving afliberept 8 mg or 2 mg in the untreated fellow eye, suggesting no drift in IOP over time,” presenting investigator Jordana Fein, MD, MS, Retina Group of Washington, told HCPLive.

PHOTON was a double-masked, 96-week, non-inferiority trial randomly assigning patients with DME to receive aflibercept 8 mg Q12W (n = 328) or Q16W (n = 163) after 3 monthly doses, or aflibercept 2 mg Q8W (n = 167) after 5 monthly doses.

This post hoc analysis assessed the change in pre-dose IOP in the aflibercept 8 mg and 2 mg groups through Week 48 of PHOTON. IOP was measured at all visits during the study period. Investigators also evaluated the cumulative incidence of pre-dose IOP ≥25 mmHg at 2 consecutive visits and pre-dose IOP ≥30 mmHg at any visit.

At the baseline, the mean pre-dose IOP in the aflibercept 2 mg Q8W, 8 mg Q12W, and 8 mg Q16W cohorts was 15.9, 15.3, and 14.9 mmHg, respectively. Until Week 48, these cohorts received an average of 7.7, 5.7, and 4.9 injections, respectively.

At Week 48, the mean pre-dose IOP was 15.7, 15.1, and 14.8 mmHg, respectively, in the aflibercept 2 mg Q8W, 8 mg Q12W, and 8 mg Q16W cohorts. The average change in pre-dose IOP from baseline was –0.1, –0.2, and –0.1 mmHg in these cohorts, respectively.

Notably, among all treatment cohorts, these mean changes in pre-dose IOP from baseline did not exceed ±1 mmHg through Week 48.

Across Week 48, the cumulative incidence of pre-dose IOP ≥25 mmHg at 2 consecutive visits was 0% across all 3 treatment cohorts. The cumulative incidence of pre-dose IOP ≥30 mmHg, at any study visit was 0%, 0.3%, and 0%, respectively, for the aflibercept 2 mg Q8W, 8 mg Q12W, and 8 mg Q16W cohorts.

“Despite a 70 µL injection volume, there were no long-term IOP adverse events seen through Week 48 with aflibercept 8 mg compared with 2 mg in 50 µL,” Fein told HCPLive.

Disclosures: Relevant disclosures for Fein include Apellis, Bausch and Lomb, Genentech/Roche, and Regeneron.

Reference

_{Fein J. Intraocular Pressure Outcomes With Aflibercept 8 mg and 2 mg in Patients With Diabetic Macular Edema Through Week 48 of the Phase 2/3 PHOTON Trial. Paper presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting. Stockholm, Sweden. July 17-20, 2024.}