CHMP Backs Aflibercept for Visual Impairment Caused by CRVO

Troy Brown

Disclosures

July 30, 2013

The therapeutic indications for aflibercept (Eylea, Bayer Pharma AG) should be extended to include treatment of visual impairment caused by macular edema secondary to central retinal vein occlusion (CRVO) in adults, according to a July 25 recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Aflibercept reduces abnormal blood vessel growth and decreases leakage and edema in the retina by blocking vascular endothelial growth factor A. The recommended dose is 2 mg administered by intravitreal injection every 4 weeks. Aflibercept was previously approved by the EMA for the treatment of neovascular (wet) age-related macular degeneration in adults.

The committee's decision was based on results from two phase 3 randomized, multicenter, double-masked, sham-controlled studies: the Controlled Phase 3 Evaluation of Repeated Intravitreal Administration of VEGF Trap-Eye In Central Retinal Vein Occlusion: Utility and Safety (COPERNICUS) trial (187 patients) and the General Assessment Limiting Infiltration of Exudates in Central Retinal Vein Occlusion with VEGF Trap-Eye (GALILEO) trial (171 patients). Patients were randomly assigned in a 3:2 ratio to receive intravitreal injections of aflibercept 2 mg or sham injections every 4 weeks for 6 months. At 6 months, patients in the sham group were allowed to cross over to receive aflibercept as needed (PRN), and those in the aflibercept group continued to receive it PRN for the next 6 months.

The primary endpoint for both trials was the proportion of patients with improved best corrected visual acuity of at least 15 letters from baseline to 24 weeks on the Early Treatment Diabetic Retinopathy Study chart. In the COPERNICUS trial, the primary endpoint was met by 56.1% of the patients in the aflibercept group and 12.3% in the sham control group (P < .001). At week 52, 55.3% of patients in the aflibercept group gained 5 or more letters compared with 30.1% of those in the sham group (P < .001).

In the GALILEO trial, the primary endpoint was met by 60.2% in the aflibercept group and 22.1% in the sham group (P < .001).

In the COPERNICUS trial at week 52, patients in the treatment group gained a mean of 16.2 letters compared with 3.8 letters for those in the sham group. In the GALILEO trial, patients in the treatment group gained a mean of 18.0 letters compared with 3.3 letters in the sham group (P < .0001).

In both trials, the most common adverse events were eye pain (13% aflibercept, 5% sham), conjunctival hemorrhage (12% aflibercept, 11% sham), and increased intraocular pressure (8% aflibercept, 6% sham).

The US Food and Drug Administration approved aflibercept for the treatment of adults with visual impairment caused by macular edema secondary to CRVO in September 2012.

The European public assessment report will be revised to include the updated summary of product characteristics after the European Commission grants marketing authorization for this indication.

The European Commission generally follows the recommendations of the CHMP and usually delivers its final decision within 3 months of the CHMP recommendation.

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