Diana Do, MD: Impact of Baseline BCVA on Aflibercept 8 mg Outcomes in DME

A post hoc analysis of the Phase 2/3 PHOTON trial demonstrated the visual and anatomic benefit of aflibercept 8 mg in patients with diabetic macular edema (DME), regardless of baseline best-corrected visual acuity (BCVA).

These data, presented at the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, showed eyes with baseline BCVA 20/50 or worse or BCVA 20/40 or better treated with aflibercept 8 mg every 12 weeks (Q12W) or every 16 weeks (Q16W) experienced a comparable improvement in vision and central retinal thickness (CRT) as the 2 mg dosed every 8 weeks (Q8W).

“It reassures us that you can use aflibercept 8 mg or aflibercept 2 mg for patients regardless of baseline BCVA,” presenting investigator Diana V. Do, MD, Byers Eye Institute, Stanford University, told HCPLive. “The benefit with choosing the aflibercept 8 mg is that patients can go every 12 weeks or 16 weeks between injections and still have excellent visual acuity outcomes.”

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. Dosing intervals were shortened from Week 16 if aflibecept 8 mg-treated patients met prespecified dose regimen modification criteria.

At baseline, the mean BCVA in the 2 mg Q8W, 8 mg Q12W, and 8 mg Q16W cohorts ranged from 55.1–57.8 letters in patients with BCVA 20/50 or worse (n = 422) and 72.6–73.2 letters in those with BCVA 20/40 or better (n = 236).

At baseline, the mean CRT ranged from 472.7–491.5 µm in patients with BCVA 20/50 or worse and 400.6–411.1 µm in those with BCVA 20/40 or better.

By Week 48, the average BCVA change from baseline was +10.7, +10.5, and +9.2 letters for the 2 mg Q8W, 8 mg Q12W, and 8 mg Q16W cohorts, respectively, in patients with baseline BCVA 20/50 or worse. For those with BCVA 20/40 or better, the changes were +6.0, +6.0, and +5.6 letters, respectively.

Meanwhile, the mean CRT change from baseline at Week 48 was –195.0, –194.7, and –172.6 µm for the 2 mg Q8W, 8 mg Q12W, and 8 mg Q16W cohorts, respectively, in patients with BCVA 20/50 or worse. For those with BCVA 20/40 or better, the changes were –99.4, –134.1, and –107.9 µm, respectively.

For the 8 mg Q12W and Q16W cohorts, respectively, 88.8% and 84.7% of patients with BCVA 20/50 or worse, and 94.6% and 96.6% of patients with BCVA 20/40 or better, maintained their randomized dosing intervals through Week 48.

“More importantly, it shows us that when you follow those [dose regimen modification] guidelines, you could have excellent visual acuity outcomes and have durability between injections, allowing our patients to receive disease control, but have longer follow-up intervals,” Do told HCPLive.

Disclosures: Relevant disclosures for Do include Apellis, Genentech, Iveric Bio, Regeneron, and others.

Reference

_{Do DV. Outcomes of Patients With DME and Baseline BCVA of 20/50 or Worse or 20/40 or Better Treated With Aflibercept 8 mg and 2 mg in 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.}