A CLINICAL STUDY — Approval of Eylea HD for the new indication was based on the results of a doublemasked trial (QUASAR) in 892 adults with macular edema following RVO. Patients were randomized to receive aflibercept 8 mg once monthly for 3 or 5 months and then every 8 weeks or aflibercept 2 mg every 4 weeks. Improvements from baseline in best-corrected visual acuity at week 36 with aflibercept 8 mg were noninferior to those with the 2-mg dose.2

ADVERSE EFFECTS — Common adverse effects (>3%) of Eylea HD in the QUASAR trial were increased intraocular pressure, blurred vision, conjunctival hemorrhage, vitreous detachment, ocular discomfort, pain, and irritation. In clinical trials for other indications, cataracts and vitreous floaters were common. Retinal vasculitis and scleritis and endophthalmitis have been reported with aflibercept.

Arterial thrombotic events (nonfatal stroke, myocardial infarction, vascular death) have been reported following intravitreal use of VEGF inhibitors, including aflibercept.

DOSAGE, ADMINISTRATION, AND COST — The recommended dosage of Eylea HD for treatment of macular edema following RVO is 8 mg administered by intravitreal injection once every 4 weeks for the first 3 to 5 doses, followed by 8 mg every 8 weeks thereafter. An every-4-week interval can be used if a response is not maintained with every-8-week dosing. One 8-mg vial of Eylea HD costs $2813; one 2-mg vial of Eylea costs $2001.3

OTHER INDICATIONS – The FDA also approved an every-4-week maintenance dosing option of Eylea HD for the other three indications. According to the manufacturer, some patients do not maintain an adequate response when switched from monthly to extended dosing intervals (every 8 or 12 weeks) and may benefit from resuming monthly injections.