The regulator issued a complete response letter (CRL) over the chemistry, manufacturing and controls (CMC) prior-approval supplement (PAS) for the Eylea pre-filled syringe.
Eylea injection is a vascular endothelial growth factor (VEGF) inhibitor designed as an injection for the eye.
It will help block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by restricting VEGF-A and placental growth factor (PLGF).
The FDA has issued CRL seeking additional information regarding manufacturing and supply processes and the completion of a usability study assessing a single injection of the Eylea pre-filled syringe in around 30 patients.
Regeneron said it will compile all the requested information and resubmit the PAS in early 2019 and continues to expect a 2019 launch of the Eylea pre-filled syringe.
Panorama is an ongoing, pivotal, double-masked, randomized and two-year study, which recruited 402 patients to study Eylea for the improvement of moderately severe to severe NPDR in patients without DME compared to sham injections.
The trial included three treatment arms, including an observational sham injection group and two Eylea treatment groups.
The firm has dosed Eylea every 8 weeks following five initial monthly doses or every 16 weeks following three initial monthly doses and one 8-week interval.
The company also announced that the phase 3 Panorama trial assessing Eylea injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) achieved its one-year (52-week) primary endpoint and key secondary endpoints.
Regeneron president and chief scientific officer Dr Georg Yancopoulos said: . “In this trial of patients with diabetic eye disease and normal vision, it is notable that without treatment more than one third of patients developed a vision-threatening complication or diabetic macular edema within one year.
“Eylea was able to reduce these complications by 68%-85% even with every four-month dosing, and moreover was able to reverse the anatomic severity of the disease.”
Sponsored by the Protocol W diabetic retinopathy clinical research network, a separate ongoing trial is assessing Eylea to treat NPDR in patients without diabetic macular edema (DME.)