FDA Approves Aflibercept sBLA for Wet Age-related Macular Degeneration

The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for an aflibercept (Eylea) injection in patients with wet age-related macular degeneration.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and restrict the ability of fluids to pass through blood vessels in the eye.

"We are pleased that the FDA has approved an updated label for EYLEA," said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron. "Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration."

The sBLA was based on results from a second year of the phase 3 VIEW 1 and 2 trials of patients with wet AMD. Participants were treated with a modified 12-week dosing schedule, where doses were given at least every 12 weeks and more often if necessary).

Data from the second year of VIEW 1 and 2 are now included in the updated aflibercept (Eylea) label. The updated label includes a warning about the potential risk of arterial thromboembolic events (ATEs), such as nonfatal stroke, nonfatal myocardial infarction, or vascular death, following intravitreal use of VEGF inhibitors, including aflibercept.

In the first year of wet AMD studies, the reported incidence of ATEs was 1.8% (32 out of 1824) in patients treated with aflibercept compared to 1.5% (9 out of 595) in patients treated with ranibizumab. Through 96 weeks, the incidences were 3.3% and 3.2%, respectively.

In diabetic macular edema (DME) studies, the incidence of ATEs in the first 52 weeks was 3.3% (19 out of 578) for patients treated with aflibercept compared to 2.8% (8 out of 287) in the control group. From baseline to week 100, the incidences were 6.4% and 4.2%, respectively.

The most common adverse reactions, occurring in ≥5% of patients receiving aflibercept injections, were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Aflibercept is also approved in wet age-related macular degeneration for 4- or 8-week dosing intervals after 3 initial monthly doses.

The vascular endothelial growth factor (VEGF) inhibitor injection was first approved in November of 2011 for the treatment of wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patient with DME.