FDA issues approval of aflibercept for treatment of patients with neovascular AMD, surprise

December 15, 2011
Lynda Charters

For the retina subspecialty, the past year was one of controversy, technologic advances, and an important approval from the FDA, as well as a surprise decision from the agency.

Key Points

For the retina subspecialty, the past year was one of controversy, technologic advances, and an important approval from the FDA, as well as a surprise decision from the agency. Patients with neovascular age-related macular degeneration (AMD), retinal vein occlusion (RVO), and retinopathy of prematurity (ROP) will ultimately benefit from the latest treatment advances, most retina specialists noted.

FDA actions

The most recent event, announced Nov. 18, was that the FDA approved aflibercept (Eylea, also known as VEGF Trap-Eye, Regeneron Pharmaceuticals) for treatment of patients with neovascular AMD. The approved dosage of aflibercept for wet AMD is 2 mg given every 4 weeks for the first 12 weeks, followed by 2 mg every 8 weeks.

A great benefit is that it requires fewer injections than ranibizumab over the long term (once a month for the first 3 months and then every 2 months as opposed to monthly for ranibizumab).

Aflibercept thereby decreases the burden on patients, their caretakers, and the healthcare system as a whole, noted Sharon Fekrat, MD, associate professor of ophthalmology, Duke University, Durham, NC.

"Instead of being administered every month, as in the case of ranibizumab, [aflibercept] can ultimately be given every 2 months, which cuts the costs and treatment burden," she said. "It also has a good safety profile.

Another benefit of [aflibercept] is that it costs $100 less per dose than ranibizumab." Another benefit pointed out by Mary Elizabeth Hartnett, MD, is that less frequent treatment with aflibercept decreases the risk, albeit small, of serious ocular complications from injections. She is a pediatric and adult retina specialist and professor of ophthalmology, University of Utah and the Moran Eye Center, Salt Lake City.

An action that seems to have taken many by surprise was FDA's decision that two clinical trials must be conducted to demonstrate the safety and effectiveness of an investigational intravitreal insert (Iluvien, Alimera Sciences) delivering fluocinolone acetonide for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy before it can decide whether to approve a new drug application (NDA) for the insert.

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