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news.Regeneron Pharmaceuticals and Bayer HealthCare have released positive results from the Phase III VIVID-DME trial of EYLEA (aflibercept) Injection indicated to treat diabetic macular edema (DME).
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The Phase III trial showed that EYLEA 2mg in both treatment groups (dosed monthly or every two months), showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation.
In the trial, patients were randomized to receive either EYLEA injection into the eye every month (n=136), EYLEA injection every two months (n=135), or the comparator treatment of laser photocoagulation (n=132).
After two years, patients receiving EYLEA injection every month had a mean gain from baseline in BCVA of 11.4 letters, which is equivalent to a gain of more than two lines on the ETDRS-eye chart, a standard chart for measuring vision.
Patients receiving EYLEA injection every two months had a mean gain from baseline in BCVA of 9.4 letters, while patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.7 letters.
Additionally, 31.1% of patients receiving EYLEA injection 2mg every two months achieved an increase of greater than or equal to 15 letters, a gain of three lines from baseline as one of the endpoints compared to the laser treatment group with only 12% achieving a similar gain.
In the trial, EYLEA had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the EYLEA treatment groups and the laser control group.
The compete two-year data from the VIVID-DME trial will be presented at upcoming medical conferences.