Regeneron Pharmaceuticals and Bayer HealthCare have announced that in an integrated analysis of two parallel Phase III studies, Eylea (aflibercept) injection has shown improvements in visual acuity at 96 weeks in patients with the neovascular (wet) form of age-related macular degeneration.
Eylea injection is a recombinant fusion protein and acts as a soluble decoy receptor that binds VEGF-A and placental growth factor, thereby inhibiting the binding and activation of these cognate VEGF receptors.
The first study, VIEW 1, included 1217 patients and was conducted in the US and Canada by Regeneron. The second study, VIEW 2, was conducted in Europe, Asia-Pacific, Japan and Latin America by Bayer HealthCare and included 1240 randomised patients.
In the first year of the Phase III studies, patients were treated with three different dosing regimens of 0.5mg of Eylea every four weeks, 2mg every four weeks, and 2mg every eight weeks following three initial monthly injections, compared to 0.5mg of ranibizumab every four weeks.
During the second year, patients were treated with the same dose per injection as in the first year and were investigated monthly to determine the need for retreatment.
In an integrated analysis, patients treated with Eylea 2mg demonstrated the visual acuity gain of 7.6 letters, compared with 8.4 letters at week 52, with an average of 11.2 injections over two years and 4.2 injections during the second year.
The study also found that the visual acuity gain from baseline in the monthly ranibizumab group at week 96 was 7.9 letters, compared with 8.7 letters at week 52, with an average of 16.5 injections over two years and 4.7 injections during the second year.
Regeneron Laboratories president George Yancopoulos said the second-year results confirm the vision gains attained by Eylea with a less than monthly dosing frequency.
"As a reminder, the recommended dose for Eylea is 2mg every eight weeks following three initial monthly injections, which demonstrated visual acuity gains that were clinically equivalent to monthly ranibizumab,” Yancopoulos added.