Aflibercept 8 mg for DME: 96-Week Results from the Phase 2/3 PHOTON Trial

Theme: Retina*
What: Retina
Part of: Retina II: Stamping out Blindness and Restoring Sight / Rétine II: Lutter contre la cécité et redonner la vue
When: 6/1/2024, 04:15 PM - 05:45 PM
Where: Room | Salle 713 AB

Abstract

Purpose: Evaluate aflibercept 8 mg vs 2 mg efficacy and safety in diabetic macular edema.

Study design: PHOTON (NCT04429503) was a multicenter randomized double-masked, 96-week (wk), Phase 2/3, non-inferiority trial.

Methods: Patients were randomized to receive aflibercept 8 mg every 12 or 16 wks after three initial monthly injections (8q12 [n=328] or 8q16 [n=163]) or aflibercept 2 mg every 8 wks after five initial monthly doses (2q8; n=167). Dosing intervals in the 8q12 and 8q16 arms could be shortened from Week (Wk) 16 and extended from Wk 52 based on protocol criteria.

Results: Least squares (LS) mean best-corrected visual acuity (BCVA) change from baseline at Wk 96 was +7.7 (2q8), +8.2 (8q12), and +6.6 (8q16) letters (LS mean difference: non-inferiority at 4-letter margin 8q12 vs 2q8: [nominal p<0.0001]; 8q16 vs 2q8: [nominal p=0.0044]). Through Wk 96, 88% (8q12) and 84% (8q16) of patients maintained ≥12- and ≥16-wk dosing intervals, respectively. In 8q16, 47% of patients had an assigned dosing interval of ≥20 wks at Wk 96. Aflibercept 8 mg and 2 mg safety outcomes were similar through Wk 96.

Conclusions: Aflibercept 8 mg maintained comparable BCVA gains vs 2 mg, with no new safety signals through 96 wks.

Presenter(s)

Presenting Author: David Wong

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