FDA OKs Aflibercept (Eylea) for All Retinal Vein Occlusions


October 07, 2014

The US Food and Drug Administration (FDA) has expanded the indication of aflibercept (Eylea, Regeneron) injection to include all forms of macular edema after retinal vein occlusion (RVO), including branch RVO (BRVO), the manufacturer announced yesterday.

Aflibercept was previously approved for macular edema after central RVO (CRVO), as well as neovascular (wet) age-related macular degeneration and visual impairment caused by diabetic macular edema. Blockages to branch retinal veins are four times as common as those to the central retinal vein, but CRVO generally poses the most significant threat to vision, the manufacturer noted in a news release.

Blockages of either kind trigger the release of vascular endothelial growth factor (VEGF), a protein that causes blood vessels to become leaky. Leakage of retinal veins leads to swelling of the macular portion of the retina.

An engineered protein, aflibercept reduces leakage and blocks the growth of new blood vessels by inhibiting both VEGF and placental growth factor, which also is angiogenic. The drug is injected into the eye. The recommended dose is 2 mg every 4 weeks for all approved indications.

The FDA based its decision to expand aflibercept's indication on the prior indication for macular edema after CRVO and a clinical trial that compared the drug with macular laser photocoagulation in 181 patients with BRVO, according to Regeneron. After 24 weeks, 53% of patients treated with aflibercept gained at least 15 letters in vision from baseline on an eye chart compared with 27% of those undergoing the laser procedure. Tested for best-corrected visual acuity, patients receiving aflibercept experienced a mean improvement of 17 letters compared with a 6.9-letter gain for the other patients.

Conjunctival hemorrhages and cataracts were the most common ocular adverse events in patients treated with the drug.


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