Regeneron's Eylea pads its armor with diabetic retinopathy approval

With a major challenger on the fast track to approval in Novartis’ brolucizumab, Regeneron’s Eylea has been on the hunt for a new indication to boost its best-in-class sales. It may have found it in diabetic retinopathy.

The FDA has approved Eylea injection for treatment of all stages of diabetic retinopathy, a condition that affects about 8 million people worldwide and is the leading cause of blindness in U.S. adults, the company said.

The new indication followed positive results from the drug’s phase 3 trial dubbed Panorama, which showed an 85% and 88% risk reduction for diabetic retinopathy patients developing proliferative diabetic retinopathy (PDR) at the one-year mark when dosing every 16 and eight weeks, respectively. Twenty percent of untreated patients developed PDR, which causes abnormal blood vessel growth on retinas and potentially vision loss, at the one-year mark, the company said.

Eylea is the only vascular endothelial growth factor inhibitor approved with two dosing options for diabetic retinopathy, according to Regeneron, allowing for either eight- or four-week treatment intervals after five initial monthly injections.  

Eylea’s newest regulatory win will help Regeneron steel itself as brolucizumab threatens the company’s grip on the wet aged-related macular degeneration (AMD) market.

RELATED: Novartis' speedy brolucizumab review tees up battle with Eylea, Lucentis

In April, the FDA granted priority review to brolucizumab for treatment of AMD after interim data from two phase 3 trials showed the drug stacked up well against Eylea in its primary endpoints and even bested the blockbuster in several secondary endpoints, including reducing retinal fluid and central subfield thickness.

Novartis is expecting a decision from the FDA by October and is building its sales division to capture the peak $1.68 billion analysts have predicted.

If it receives approval, brolucizumab could create problems for Eylea’s sales, which showed double-digit growth in 2018 despite analyst concerns. So far this year, growth has been more modest: The drug posted $1.74 billion in global sales in the first quarter, an 8.4% increase over the previous year.

RELATED: Regeneron's Eylea hits double-digit growth for 2018, and it's 'far from done,' CEO says

Regeneron isn’t only closely watching brolucizumab’s progress. Roche’s Lucentis already competes head-to-head with Eylea in AMD, and the Swiss drugmaker is pushing its next-gen AMD challenger faricimab through phase 3. While phase 2 data for Roche’s hopeful showed comparable results to Lucentis in 12- and 16-week treatment schedules, analysts said the improvement wasn’t impressive and paled in comparison to brolucizumab and Eylea, which received its own 12-week treatment indication approval in August.

Editor's Note: This story has been updated to clarify Eylea's phase 3 trial data for its 16- and eight-week dosing regimens and Roche's phase 2 dosing regimen for faricimab.