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FDA approves Eylea to treat diabetic retinopathy in patients with DME
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The FDA approved Eylea injection to treat diabetic retinopathy in diabetic macular edema, according to a press release from Regeneron.
The approval was based on 2-year data from the phase 3 VISTA-DME and VIVID-DME studies of 862 patients, which compared Eylea (aflibercept) 2 mg monthly, Eylea 2 mg every 2 months after five initial monthly injections and macular laser photocoagulation.
Patients treated with Eylea every 1 to 2 months showed statistically significant improvements compared with the control group, the release said. On average, patients in both Eylea groups gained the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.
At year 2, 38% of patients who received Eylea achieved a two-step or better improvement on the diabetic retinopathy severity scale compared with 16% of control patients in the VISTA-DME trial. In the VIVID-DME trial, approximately 30% of Eylea patients achieved a two-step or better improvement compared with 8% of control patients.
The recommended dosage is 2 mg every 8 weeks after five initial monthly injections. Eylea may be dosed as frequently as 2 mg every 4 weeks, but there was no additional efficacy for dosing every 4 weeks vs. every 8 weeks, the release said.
Eylea is also approved to treat wet age-related macular degeneration, DME and macular edema secondary to retinal vein occlusions. It had previously received breakthrough therapy designation and priority review to treat diabetic retinopathy in DME.