Mark Barakat, MD: Stable IOP Outcomes After Aflibercept 8 mg in DME

Intraocular pressure (IOP) outcomes were comparable in eyes with diabetic macular edema (DME) receiving intravitreal aflibercept 8 mg or 2 mg, according to a new analysis of the phase 2/3 PHOTON trial.¹

Presented at the 2024 Association for Research in Vision and Ophthalmology (ARVO) Meeting, the study data showed minimal changes from baseline through 48 weeks in IOP across all aflibercept treatment groups.

In an interview with HCPLive, Mark Barakat, MD, the founder and director of research at Retina Macula Institute of Arizona, indicated the one-year data across the posthoc analysis of PHOTON demonstrated the strong tolerability of aflibercept 8 mg in patients with DME.

“The take-home message here is that the data was spectacularly unimpressive, meaning that there’s nothing to see here,” Barakat told HCPLive. “When you look at eyes treated with the 8 mg dose, with the pre-dose IOP throughout one year’s worth of data, it remained remarkably stable. If you look at the changes, there’s hardly any difference.”

Patients with DME in the randomized, double-masked 96-week PHOTON trial received aflibercept 8 mg every 12 (Q12W) or 16 weeks (Q16W) after 3 monthly doses or aflibercept 2 mg every 8 weeks (Q8W) after five monthly doses. PHOTON measured the IOP of all patients at all visits during the study.

For this analysis, the mean pre-dose IOP and the change in pre-dose IOP from baseline were assessed through Week 48, as well as the cumulative incidence of the 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 was 15.9 mmHg, 15.3 mmHg, and 14.9 mmHg in the aflibercept 2 mg Q8W, aflibercept 8 mg Q12W, and aflibercept 8 mg Q16W groups, respectively. Patients received an average of 7.7, 5.7, and 4.9 injections through Week 48 in each group, respectively.

Upon analysis, at Week 48, the mean pre-dose IOP in the aflibercept 2 mg Q8W, aflibercept 8 mg Q12W, and aflibercept 8 mg Q16W groups were 15.7, 15.1, and 14.8 mmHg, respectively. As a result, the corresponding change in mean pre-dose IOP from baseline was –0.1, –0.2, and –0.1 mmHg.

Across each treatment group, the mean change in pre-dose IOP through Week 48 did not exceed ±1 mmHg. Until Week 48, the cumulative incidence of pre-dose IOP ≥25 mmHg at 2 consecutive visits was 0% for all 3 treatment groups.

Meanwhile, the cumulative incidence of pre-dose IOP ≥30 mmHg at any visit was 0%, 0.3%, and 0% in the aflibercept 2 mg Q8W, aflibercept 8 mg Q12W, and aflibercept 8 mg Q16W groups, respectively.

“We look forward to having year two data coming out because there are different concerns regarding IOP spikes with intraocular injections,” Barakat told HCPLive. “There’s the concern about the slow, chronic gradual rise which we look for in the two-year data, but also, you look at the immediate spikes and thus far in year 1, it looks really good.”

Disclosures: Barakat reports relevant financial disclosures with Abbvie, Apellis, Genentech, Regeneron, Roche, and others.

References

_{Barakat MR. Intraocular pressure outcomes with intravitreal injection of aflibercept 8 mg and 2 mg in patients with diabetic macular edema through Week 48 of the phase 2/3 PHOTON trial. Poster presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Meeting, May 5–9, 2024.}