Roche has won FDA approval for Lucentis as a treatment for eye complications in more people with diabetes, boosting the target population of the drug.
Lucentis (ranibizumab) has become the first medicine in the US to be cleared to treat diabetic retinopathy in people with diabetic macular edema (DME), which affects around 750,000 Americans a year and is a leading cause of blindness.
According to the FDA, around a third of all people with diabetes aged over 40 show some signs of retinopathy and escalating levels of diabetes are fast becoming a “serious public health crisis”.
Lucentis’ approval “gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” according to Edward Cox, who heads the agency’s Office of Antimicrobial Products.
In pivotal studies, participants treated with Lucentis showed significant improvement in the severity of their diabetic retinopathy at two years compared to patients who did not receive an injection, according to the agency, which granted Roche’s drug breakthrough status for this indication.
The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions and wet age-related macular degeneration (AMD).
Lucentis was Roche’s fourth biggest-selling product last year, bringing in 1.7bn Swiss francs ($), and while it grew 2% in the year the product has been losing momentum and the company said during its annual results meeting last month that it expects 2015 to be even more challenging thanks to competition in DME and AMD.
Roche’s drug is being challenged in the market by Bayer’s Eylea (aflibercept) as well as newer entrants such as Allergan’s Ozurdex (intravitreal dexamethasone).
“I would be a little bit more cautious about Lucentis as we move forward,” said Roche’s chief operating officer Dan O’Day on the firm’s fourth-quarter results call, who noted sales of the drug are expected to flatten or potentially even decline this year.
Lucentis is sold by Novartis outside the US.