FDA approvals

FDA approves Eylea for treatment of diabetic macular edema

The U.S. Food and Drug Administration has approved Eylea for treatment of diabetic macular edema, according to a Regeneron Pharmaceuticals press release.

This is the third FDA-approved indication for the aflibercept injection, which was approved for treatment of neovascular age-related macular degeneration in 2011 and for treatment of macular edema following central retinal vein occlusion in 2012.

The recommended dosage for use in diabetic macular edema is 2 mg every 2 months after five initial monthly injections.

Data from 1-year results of the phase 3 VISTA-DME and VIVID-DME studies, which compared aflibercept 2 mg given monthly, aflibercept 2 mg given every 2 months after five initial monthly injections, and macular laser photocoagulation at baseline and then as needed, were the basis of the FDA decision, according to the release. Both studies demonstrated significant improvements in best corrected visual acuity with use of aflibercept compared with controls.

Aflibercept may also be dosed as frequently as 2 mg every 4 weeks; however, clinical data did not demonstrate additional efficacy compared with every 8 weeks, according to the release.

Common treatment-related adverse events included conjunctival hemorrhage, eye pain, cataract and vitreous floaters. Frequent non-ocular treatment-related adverse events included hypertension and nasopharyngitis.

Aflibercept injection has been submitted for regulatory approval for the treatment of DME in Japan, Asia-Pacific and Latin America. Regeneron has also made regulatory submissions in the U.S. and E.U. for aflibercept for the treatment of macular edema following branch retinal vein occlusion, according to the release.

The U.S. Food and Drug Administration has approved Eylea for treatment of diabetic macular edema, according to a Regeneron Pharmaceuticals press release.

This is the third FDA-approved indication for the aflibercept injection, which was approved for treatment of neovascular age-related macular degeneration in 2011 and for treatment of macular edema following central retinal vein occlusion in 2012.

The recommended dosage for use in diabetic macular edema is 2 mg every 2 months after five initial monthly injections.

Data from 1-year results of the phase 3 VISTA-DME and VIVID-DME studies, which compared aflibercept 2 mg given monthly, aflibercept 2 mg given every 2 months after five initial monthly injections, and macular laser photocoagulation at baseline and then as needed, were the basis of the FDA decision, according to the release. Both studies demonstrated significant improvements in best corrected visual acuity with use of aflibercept compared with controls.

Aflibercept may also be dosed as frequently as 2 mg every 4 weeks; however, clinical data did not demonstrate additional efficacy compared with every 8 weeks, according to the release.

Common treatment-related adverse events included conjunctival hemorrhage, eye pain, cataract and vitreous floaters. Frequent non-ocular treatment-related adverse events included hypertension and nasopharyngitis.

Aflibercept injection has been submitted for regulatory approval for the treatment of DME in Japan, Asia-Pacific and Latin America. Regeneron has also made regulatory submissions in the U.S. and E.U. for aflibercept for the treatment of macular edema following branch retinal vein occlusion, according to the release.