David M. Brown, MD: Maintaining Dosing Intervals with Aflibercept 8 mg in DME

The majority of patients with diabetic macular edema (DME) receiving aflibercept 8 mg treatment maintained 12- or 16-week dosing intervals, according to new results from the PHOTON trial

Those who did not maintain their randomized dosing intervals appeared to have more severe disease at baseline than patients who maintained their randomized dosing intervals, with the trend reportedly more pronounced in patients receiving aflibercept 8 mg every 16 weeks.

“The majority of patients can be treated less frequently with this drug, which is really important because most of them are working, they often have troubles with compliance,” presenting author David M. Brown, MD, Retina Consultants of Texas, told HCPLive. "And a lot of our failures in the treatment landscape are because of treatment non-compliance. Anything we can do to get the same great effects as we've had with 2mg aflibercept, but with less burden, is certainly better for patients and their physicians."

Led by Brown, the investigative team aimed to evaluate the baseline clinical characteristics of patients with DME who received intravitreal aflibercept 8 mg and maintained their randomized dosing intervals versus patients whose intervals were shortened after meeting prespecified criteria through Week 48.

The phase 2/3 PHOTON trial is an ongoing, double-masked, 96-week, non-inferiority trial that randomized patients with DME to receive aflibercept 8 mg every 12 (8q12; n = 328) or 16 weeks (8q16; n = 163) after 3 monthly doses or aflibercept 2 mg (2q8; n = 167). every 8 weeks after 5 monthly doses. Starting at Week 16, dosing intervals were shortened to a minimum of 8 weeks if aflibercept 8 mg-treated patients met prespecified dose regimen modification criteria.

At baseline, investigators indicated best-corrected visual acuity (BCVA), central retinal thickness (CRT), and Diabetic Retinopathy Severity Scale (DRSS) scores to be generally balanced across all 3 treatment groups in the overall population. Of those who completed the visit at Week 48, 273 of 300 (91.0%) in the 8q12 group and 139 of 156 (89.1%) in the 8q16 group maintained their randomized dosing intervals.

Moreover, 27 of 300 (9.0%) in the 8q12 and 17 of 156 (10.9%) patients in the 8q16 groups met dose regimen modification criteria and had their dosing intervals shortened. Data showed the mean baseline BCVA in eyes with maintained vs shortened dosing intervals was 63.9 vs. 59.4 letters in the 8q12 group and 62.7 vs. 53.7 letters in the 8q16 group.

Additionally, the analysis showed the baseline CRT for maintained vs. shortened dosing intervals was 444.9 vs. 511.4 µm in the 8q12 group and 447.1 vs. 534.8 µm in the 8q16 group. The baseline DRSS score for maintained vs. shortened dosing intervals was ≤47 in 33.7% vs. 40.7% of patients in the 8q12 group and 26.6% vs. 41.2% of patients in the 8q16 group. Brown and colleagues noted there were no clinically meaningful differences observed based on age, body mass index (BMI), or HbA1c at baseline.

For more insight into the findings from the phase ⅔ trial, watch our interview with Brown at ARVO 2023.

David M. Brown, MD reports having received consultant fees from Regeneron, Bayer, and Genentech/Roche.

References

1. Brown DM. Baseline Disease Characteristics of Patients Who Maintained 12- and 16-Week Aflibercept 8 mg Dosing Versus Patients with Shortened Treatment Intervals Through Week 48 in the Phase 2/3 PHOTON Trial. Presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting; April 2023; New Orleans, LA.