Regeneron gets FDA approval for Eylea injection prefilled syringe

The only anti-VEGF approved to treat four retinal conditions with a single dose strength prefilled syringe, Eylea also is offered in multiple dosing intervals, giving doctors flexibility to address patients’ individual needs.

Regeneron Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for its aflibercept injection (Eylea) prefilled syringe.

The 2 mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer aflibercept that requires fewer preparation steps compared to vials. Market supply of the prefilled syringe is expected to be available to physicians and patients this year.

“With eight pivotal Phase 3 trials and millions of injections used around the world, Eylea sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron. “This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients.”

The sterilized prefilled syringe offers the same medicine as the currently available Eylea, in an easier to use and administer presentation.

In the United States, Eylea is indicated to treat neovascular (wet) age-related macular degeneration (Wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).

An expanded indication for aflibercept injection is now approved by the FDA to treat all stages of DR.

The PANORAMA prospective trial examined whether an anti-VEGF could also help prevent worsening disease in patients with NPDR without DME.

“The PANORAMA trial marks the first time we have a prospective, multicenter, double-masked, randomized, controlled trial evaluating these high-risk NPDR eyes without  DME,” said Charles C. Wykoff, MD, PhD, Retina Consultants of Houston.

For the treatment of DR, aflibercept may be dosed every eight weeks following five initial monthly injections, or every four weeks.

“All of our previous DR analyses come from eyes with proliferative diabetic retinopathy or NPDR with DME,” Dr. Wykoff said. “This the first time we have NPDR without DME. It’s an important landmark trial for that key reason.”

Dr. Wykoff said that anatomically, there is strong evidence that anti-VEGF therapy provides “dramatic benefit, both through improving DR severity levels and decreasing the development of PDR and center-involved DME.

Earlier this year, Regeneron reported that 74% of patients with severe NPDR who were treated with Eylea did not develop vision-threatening events at one year, whereas 53% of untreated patients did.