Changing Dosage Regimens in Patients with Diabetic Macular Edema, with Mark Barakat, MD

At the 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, Mark Barakat, MD, founder and director of research at Retina Macula Institute of Arizona, presented a post-hoc analysis examining the shortening or extending of aflibercept 8 mg dosage through week 96 of the PHOTON trial.

“So here we have an agent that’s been shown to go out to not just 12, 16 weeks, but in some patients even longer, like 20 or 24 weeks,” Barakat told HCPLive. “Right now, we’re very fortunate to have anti-VEGF agents, which really give us good results. But durability is king. So here we have something that can stretch things out longer. From a patient’s perspective, it’s a lot less injections, perhaps fewer visits.”

In PHOTON, patients with diabetic macular edema were randomly assigned to aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16, respectively). After 3 monthly doses, patients were eligible for dosing modification so long as they met prespecified criteria. Dose interval shortening to a minimum 8 weeks was permitted in years 1 and 2; dose interval extension to a maximum of 24 weeks was only permitted in year 2.1

Barakat and colleagues noted that dosing intervals were shortened for 12.5% and ≤16.5% of patients treated with 8q12 (n = 256) and 8q16 (n = 139) who continued until Week 96. The shortened 8q12 group exhibited best-corrected visual acuity (BCVA) at baseline and Week 96 of 61.5 and 66.9; the maintained group exhibited a 63.5 and 72 BCVA, and those extended exhibited 64.4 and 74.4 letters.1

Additionally, investigators indicated that corresponding retinal thickness (CRT) was 509.1 and 333.9, 488.2 and 330.2, and 431.1 and 228.3 µm, respectively. BCVA at baseline and week 96 for the shortened, maintained, and extended subgroups was 55.4 and 62.5, 62.7 and 68.3, and 63 and 72.2 letters, respectively. Corresponding CRT was reduced from 521.5 to 341.5, 472.2 and 343.3, and 418.6 and 256 µm.1

A combined 8 mg analysis revealed that baseline factors with interval shortening versus maintained or extended were shorter duration of diabetes (OR [odds ratio] .85; 95% CI, .73-1 for every 5-year increase) and thicker CRT (OR, 1.18; 95% CI, 1.07-1.31] for every 50-µm increase). Lower baseline CRT was associated with interval extension versus maintained (OR, .82; 95% CI, .74-.91 for every 50-µm increase).1

Ultimately, Barakat and colleagues indicated that all dosing intervals exhibited substantial BCVA gains and CRT improvements at week 96. Patients with shorter diabetes durations or thicker CRT at baseline were more likely to have dosing intervals shortened; however, those with thinner CRT at baseline were more likely to have their dosing intervals extended.1

“Frankly, apart from who gets shortened and who gets extended and maintained, the important thing is, if you look back at it, all these patients did really well in terms of anatomy and vision,” Barakat said.

Barakat reports the following disclosures: Oxurion, Janssen, RegenxBio, Novartis, Biocryst, and others.

References

1. Barakat, Mark R. Baseline characteristics and outcomes of patients treated with aflibercept 8 mg at shortened, maintained, or extended dosing intervals through 96 weeks in PHOTON. Abstract presented at Association for Research in Vision and Ophthalmology in Salt Lake City, UT, from May 3 – May 8, 2025.