Eylea aflibercept ophthalmic solution: Additional Phase III data

Additional data from the double-blind, international Phase III COPERNICUS trial in 188 patients with macular edema due to CRVO showed that a significantly greater proportion of patients treated with monthly 2 mg intravitreal Eylea for 6 months and then as needed had their BCVA improve by >=15 letters from baseline to 1 year on the ETDRS eye chart vs. patients who received sham control for 6 months followed by Eylea as needed (55.3% vs. 30.1%, p=0.0006). Additionally, Eylea significantly improved BCVA as measured by mean change from baseline on the ETDRS eye chart at 1 year vs. patients who switched from sham control to Eylea (16.2 vs. 3.8 letters gained, p<0.0001).

Patients received monthly sham control (n=74) or Eylea (n=114) for 6 months. At the end of 6 months, all patients randomized to Eylea continued treatment as needed for another 6 months, while patients receiving sham control were eligible to crossover to Eylea. During the second 6 months, all patients were eligible for rescue laser treatment. Data were presented at the World Ophthalmology Congress in Abu Dhabi. In 2010, Regeneron and Bayer reported top-line data from COPERNICUS showing that Eylea met the primary endpoint of a significantly greater proportion of patients whose visual acuity improved by >=15 letters from baseline to 6 months on the ETDRS eye chart vs. sham control (56.1% vs. 12.3%, p<0.0001) (see BioCentury, Jan. 3, 2011). ...