Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission, with a target action date of 23 October 2014.
Regeneron chief scientific officer and Regeneron Laboratories president George Yancopoulos said the company is happy that the FDA has accepted the sBLA for EYLEA for the treatment of macular edema following BRVO, an important cause of vision loss.
"This is the fourth regulatory submission in the U.S. for EYLEA and, if approved, we hope it will provide a new treatment option for patients with macular edema following BRVO," Yancopoulos said.
The sBLA submission is based on the positive results from the Phase III VIBRANT trial, which was a double-masked, randomized, active-controlled study that evaluated 183 patients with Macular Edema following BRVO.
In the trial, patients were given either intravitreal EYLEA 2mg every four weeks or laser treatment for 24 weeks.
Primary objective of the trial was to assess the efficacy and safety of EYLEA in improving best-corrected visual acuity compared to laser treatment at week 24.
The company said that the trial is ongoing through week 52.
In the US, EYLEA was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for macular edema following Central Retinal Vein Occlusion (CRVO) in September 2012.
The drug has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO.
Regulatory submissions have also been made in the US and the EU for EYLEA for the treatment of Diabetic Macular Edema (DME).
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea, with Regeneron maintaining exclusive rights of the drug in the US and Bayer having exclusive marketing rights outside the US, where the firms equally share the profits from its sales, except for Japan where Regeneron receives a royalty on net sales.