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FDA Approves Aflibercept (Eylea) Injection for Macular Edema

Third agency nod for VEGF inhibitor

The FDA has OK’d the use of aflibercept (Eylea, Regeneron Pharmaceuticals) injection for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously approved indication of macular edema following central retinal vein occlusion (CRVO).

The recommended dosage of aflibercept for patients with macular edema following RVO is 2 mg every 4 weeks.

RVO, the second most common retinal vascular disease, occurs when there is an obstruction in a vein in the retina. The blockage causes a backup of blood and leads to poor blood supply in the affected retina. This, in turn, results in the release of vascular endothelial growth factor (VEGF), a naturally occurring protein in blood vessels that causes them to become leaky. The leaky vessels result in macula edema, i.e., swelling in the center portion of the eye (the macula), which is the most common cause of vision impairment in RVO.

In CRVO, the blockage occurs in the central retinal vein, the main blood vessel that carries de-oxygenated blood out of the back of the eye. In BRVO, the blockage occurs in a smaller retinal vein that drains blood away from the retina. RVO affects approximately 1% to 2% of adults older than 40 years of age. While BRVO is four times more common than CRVO, CRVO generally is the most significant threat to vision.

The expanded indication for aflibercept is based on the previously approved indication for macular edema following CRVO and on positive results from the double-masked, randomized, controlled phase III VIBRANT study in 181 patients with macular edema following BRVO.

The VIBRANT trial compared aflibercept 2 mg once every 4 weeks with macular laser photocoagulation (control). At 24 weeks, significantly more patients treated with aflibercept gained at least 15 letters in vision (three lines on an eye chart) from baseline, as measured on the Early-Treatment Diabetic Retinopathy Study (ETDRS) chart — the study’s primary endpoint — compared with patients who received control (53% vs. 27%, respectively; P P

The incidence of non-ocular serious adverse events (SAEs) was 8.8% in the aflibercept group compared with 9.8% in the control group. One death and one Anti-Platelet Trialists’ Collaboration (APTC)-defined arterial thromboembolic event (non-fatal stroke) occurred during the trial, both in patients in the control group. The most common ocular adverse events in patients treated with aflibercept included conjunctival hemorrhage and cataract. No cases of intraocular inflammation occurred in either treatment group. There was one ocular SAE (traumatic cataract) in a patient in the aflibercept group.

VIBRANT was the first phase III trial in patients with macular edema following BRVO in which an anti-VEGF agent was directly compared with laser photocoagulation at baseline. The study lasted 52 weeks, and the 1-year results were presented at the American Society of Retina Specialists annual meeting in August 2014.

Eylea (aflibercept) is available as a single 2-mg intravitreal injection for all approved indications. The drug is used in the U.S. for the treatment of wet age-related macular degeneration, for macular edema after RVO, and for diabetic macular edema.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. The drug is designed to block the growth of new blood vessels and to decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF) — two growth factors involved in angiogenesis. Aflibercept helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors, as shown in preclinical studies.

Source: Regeneron Pharmaceuticals; October 6, 2014.

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