Roche's Lucentis nabs FDA 'breakthrough' tag for diabetic eye disease

Roche's ($RHHBY) Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.

Regeneron's ($REGN) Eylea got the same "breakthrough" tag in September but had not yet submitted its FDA app at the time. Roche put in its request for the diabetic retinopathy use in August.

The drugs already duke it out in other indications, including wet age-related macular degeneration. As the relative newcomer, Eylea has quickly racked up sales and market share, beating sales forecasts as it soared to blockbuster status.

Beating Eylea to the diabetic retinopathy market could help Lucentis fight back. Vision loss related to long-term blood sugar problems is a big problem, and it's growing as diabetes cases mount in the U.S. Both drugs are already approved for diabetic macular edema (DME), but retinopathy affects millions more patients.

Of the 29 million U.S. adults with diabetes, some 7.7 million have diabetic retinopathy, compared with 1.5 million diagnosed cases of DME. And there's no currently approved treatment for diabetic retinopathy.

- read the EyeWireToday story

Special Reports: Top 15 drug launch superstars - Eylea | Top 10 drugmakers by 2013 revenue - Roche

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