Industry News — Clinical Updates
VIVID-DME Phase 3 Results Show Sustained Improvement in BCVA Using Aflibercept for Treatment of DME
Regeneron Pharmaceuticals, Inc (Tarrytown, New York) has announced that in the phase 3 VIVID-DME trial of aflibercept for the treatment of diabetic macular edema (DME), 2 mg dosed monthly and 2 mg dosed every 2 months (after 5 initial monthly injections), showed a sustained improvement from baseline in best-corrected visual acuity (BCVA) at week 100 (2 years) compared with laser photocoagulation.
Patients were randomized to receive either 2 mg aflibercept dosed monthly (n = 136), 3 mg dosed every 2 months after 5 initial monthly injections (n = 135), or the comparator treatment of laser photocoagulation (n = 132). After 2 years, patients in the monthly arm had a mean change from baseline BCVA of 11.4 letters (10.5 letters at 52 weeks, P < .0001 vs laser). Patients in the 2-month treatment arm had a mean change from baseline BCVA of 9.4 letters (10.7 letters at 52 weeks, P < .0001 vs laser). Patients in the laser arm had a mean change from baseline BCVA of 0.7 letters (1.2 letters at 52 weeks).
Additionally, 31.1% of patients in the 2-month arm achieved an increase ≥ 15 letters (approximately 3 lines of vision) from baseline (P = .0001), 38.2% of patients in the monthly arm achieved an increase ≥ 15 letters from baseline (P < .0001), and 12.1% of patients in the laser control arm achieving similar vision gains.
There was a similar overall incidence of adverse events (AEs), ocular serious AEs, and nonocular serious AEs across the aflibercept treatment groups and the laser control group. The most frequent ocular AEs included conjunctival hemorrhage, cataract, and increased intraocular pressure. The most frequent nonocular AEs included nasopharyngitis and hypertension.
Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (nonfatal stroke, nonfatal myocardial infarction, and vascular death) were similar across the aflibercept treatment groups and laser control group, with events occurring in 8 out of 136 patients in the aflibercept monthly group, 5 out of 135 patients in the aflibercept 2-month group, and 3 out of 133 patients in the laser group. Four out of 136 patients died in the aflibercept monthly group, compared with 6 out of 135 patients in the aflibercept 2-month group and 1 out of 133 patients in the laser treatment group.
Updated July 22, 2014