OBJECTIVES: To explore clinical outcomes in individuals with diabetic macular edema (DME) in faricimab pivotal trials with baseline best corrected visual acuity (BCVA) of 20/50 or worse.

METHODS: Subgroup analyses were conducted using the DME intent-to-treat population from the phase 3 YOSEMITE and RHINE trials with baseline BCVA of ≤20/50 (letter score, <69) based on Protocol T methodology. Changes from baseline in BCVA and central subfield thickness (CST) at Years 1 and 2 were compared between faricimab Q8W, faricimab personalized-treatment-interval (PTI) dosing, and aflibercept Q8W arms. Treatment intervals achieved at Years 1 and 2 for faricimab PTI arms were also explored.

RESULTS: At Year 1, in the YOSEMITE ≤20/50 subgroup, the mean (SE) BCVA improvement was 11.8 (0.71), 12.9 (0.71), and 11.9 (0.71) in the faricimab Q8W (n=220), faricimab PTI (n=220), and aflibercept Q8W (n=219) arms, respectively. For the same subgroup in RHINE, the mean (SE) improvement was 13.8 (0.65), 11.8 (0.63), and 11.5 (0.64) in the faricimab Q8W (n=217), faricimab PTI (n=219), and aflibercept Q8W (n=214) arms, respectively. BCVA gains were maintained across treatment arms in both studies at Year 2. Within the faricimab PTI arms of both studies, >70% of patients ≤20/50 achieved ≥Q12W dosing at Year 1, and >75% of patients achieved ≥Q12W dosing at Year 2 across studies. Reductions in CST were numerically greater in faricimab arms compared to aflibercept at Year 1 and Year 2.

CONCLUSIONS: BCVA gains at Years 1 and 2 were comparable between faricimab arms and aflibercept among patients with baseline ≤20/50. Durability achieved in faricimab PTI arms suggests these vision outcomes with fewer injections can reduce healthcare resource use for patients, providers, and payers.