FDA approves therapies for AMD, insomnia

February 15, 2012

FDA has approved an intravitreal injection to treat patients with wet AMD and zolpidem to treat insomnia.

(Eylea, Regeneron Pharmaceuticals)

Wet age-related macular degeneration (AMD) is 1 of the leading causes of vision loss and blindness in Americans age 60 years and older. On November 18, 2011, FDA approved aflibercept once-monthly intravitreal injection indicated to treat patients with wet (neovascular) AMD.

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. Although uncommon 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.

Dosing. Aflibercept is available as a 40-mg/mL solution for intravitreal injection in a single-use vial. The recommended dose for aflibercept is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although aflibercept may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when aflibercept was dosed every 4 weeks compared to every 8 weeks.