Phase III Eylea trial results show BCVA improvement

February 12, 2014

A phase III VISTA-DME trial of aflibercept (Eylea) injection-a treatment for diabetic macular edema (DME)-showed a sustained improvement from baseline in the best-corrected visual acuity (BCVA) at week 100, compared with laser photocoagulation.

 

Tarrytown, NY-A phase III VISTA-DME trial of aflibercept (Eylea) injection-a treatment for diabetic macular edema (DME)-showed a sustained improvement from baseline in the best-corrected visual acuity (BCVA) at week 100, compared with laser photocoagulation.

The 52-week results (primary analyses) from the Regeneron Pharmaceuticals Inc. and Bayer HealthCare study have been previously reported.

Patients in the trial-which included aflibercept 2 mg dosed monthly (2Q4) and aflibercept 2 mg dosed every 2 months (after 5 initial monthly injections, 2Q8)-where randomly assigned to received either aflibercept 2Q4 (n = 155), aflibercept 2Q8 (n = 152), or the comparator treatment of laser photocoagulation (n = 154).

After 2 years, patients receiving aflibercept 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks). Patients receiving aflibercept 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks).

“These data showed that treatment with (aflibercept) in this trial improved vision and maintained the improvement over 2 years in patients with (DME),” said George D. Yanocopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. “These results are particularly encouraging given that 43% of patients in this study had previously received (anti-vascular endothelial grown factor) therapy.”

Full 2-year data from the trial will be presented at upcoming medical conferences. Additionally, 2-year data from the similarly designed VIVID-DME trial are expected later this year. Both the VISTA-DME and the VIVID-DME trials will continue as planned up to 148 weeks.

Bayer HealthCare and Regeneron are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to the drug in the United States, while Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of the drug, except for Japan where Regeneron receives a percentage on net sales.

 

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