New molecular entity: Aflibercept once-monthly intravitreal injection is FDA approved to treat patients with wet (neovascular) age-related macular degeneration.
On November 18, 2011, FDA approved aflibercept once-monthly intravitreal injection indicated to treat patients with wet (neovascular) AMD.
Efficacy. Aflibercept's efficacy was established in 2 randomized, multicenter, double-masked, active-controlled trials (VIEW1 and VIEW2) enrolling 2,412 patients (mean age of 76 years) with wet AMD. Patients were randomly assigned to 1 of 4 dosing regimens: 1) aflibercept administered 2 mg every 8 weeks following 3 initial monthly doses; 2) aflibercept administered 2 mg every 4 weeks; 3) aflibercept 0.5 mg administered every 4 weeks; and 4) ranibizumab administered 0.5 mg every 4 weeks. In both studies, the primary efficacy end point was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at week 52 compared to baseline. Aflibercept 2 mg every 8 weeks and aflibercept at 2 mg every 4 weeks were found to be as efficacious and clinically equivalent to ranibizumab 0.5 mg every 4 weeks.
Safety. In the VIEW1 and VIEW2 clinical trials, the most common adverse events (occurring in >5%) seen in aflibercept patients were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure. Intravitreal injections have been associated with endophthalmitis and retinal detachment, and therefore proper injection technique must be used during administration of aflibercept. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed accordingly. Elevated intraocular pressure is common acutely following intravitreal injection of aflibercept. Sustained increase in pressure should be monitored and may cause perfusion to the optic nerve. Although uncommon (<2% of participants) in these clinical trials, arterial thromboembolic events did occur following intravitreal use of aflibercept. Aflibercept is contraindicated in patients with ocular or periocular infections or active ocular inflammation.