Aflibercept subgroup performance in the phase 2/3 photon trial through week 48
The drug performed well in the various subgroup analyses of patients with and without previous treatment for diabetic macular edema (DME).
(Image credit: AdobeStock/dTosh)
The Photon Study Investigators reported their findings in the phase 2/3 trial with the 2-mg and 8-mg doses of aflibercept (Eylea, Regeneron) at the annual meeting of the American Society of Retina Specialists in Stockholm. Generally speaking, the drug performed well in the various subgroup analyses of patients with and without previous treatment for diabetic macular edema (DME), in those with better and worse baseline visual acuities, and regarding its effects on the pretreatment intraocular pressure (IOP) levels.
The Photon Trial (NCT04429503) was a 96-week in which patients were randomized to either the 8-mg dose of aflibercept every 12 or 16 weeks after 3 monthly doses or the 2-mg dose every 8 weeks after 5 monthly doses.
Outcomes based on baseline vision
Diana Do, MD, from the Byers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, reported on the visual and anatomic outcomes achieved with the 2 doses of aflibercept in patients with DME based on the baseline best-corrected visual acuities (BCVAs) of 20/50 or worse and 20/40 or better.
She reported, “The aflibercept 8-mg dose demonstrated meaningful visual and anatomic improvements from baseline to week 48 regardless of the baseline vision. Patients with the worse vision achieved numerically greater visual gains and improvements in the central retinal thickness than those with the better vision.”
More patients treated with the 8-mg dose with a better baseline BCVA maintained their randomized dosing interval through 48 weeks compared with those with worse BCVA.
Outcomes based on previous DME treatment
Dennis Marcus, MD, from the Southeast Retina Center, and the Department of Ophthalmology, Medical College of Georgia, both in Augusta, reported on the effects of the 2 aflibercept doses in patients who had or had not undergone previous treatment for their DME before receiving aflibercept.
This subgroup analysis showed that the outcomes were generally comparable across the treatment groups among the patients who did and did not receive previous DME treatment. The gains in the BCVA and the proportions of patients with 2 steps or greater improvement in the Diabetic Retinopathy Severity Scale scores at weeks 48 trended numerically lower across the treatment groups in patients with previous treatment of DME compared with those who had not been treated previously for DME.
The patients randomized to the 8-mg dose maintained 12-week or longer dosing intervals out to week 48 regardless of their previous treatment status.
Treatment effects on IOP
Jordana Fein, MD, from the Retina Group of Washington, Fairfax, VA, reported on the effects of the 2 doses of aflibercept on the pretreatment IOP in patients with DME who had an IOP of 25 mmHg or higher and in those with an IOP of 30 mmHg or higher.
The subgroup analysis showed that the IOPs of the patients before treatment with both the 8-mg and 2-mg doses of aflibercept were comparable. The investigators saw minimal changes from the baseline IOP levels through week 48 in all treatment groups.
