Regeneron AMD drug beats Lucentis on dosing in PhIII

Barreling toward regulatory filings in the U.S. and Europe, Regeneron says its experimental AMD drug performed as well as Lucentis in two late-stage trials, with half of the direct injections in the eye required by the blockbuster Roche drug.

VEGF Trap-Eye, which is partnered with Bayer as a new treatment for wet age-related macular degeneration, is angling to become a first-line therapy by giving physicians an option of giving an injection every other month instead of the monthly injections needed for Lucentis.

Regeneron recruited more than 1,200 patients for its Phase III trial and found that 95 percent of the patients in the VEGF Trap-Eye arm maintained their vision with fewer injections than the 94 percent of patients getting Lucentis. And Bayer--which has ex-U.S. rights--is reporting comparable data from its VEGF Trap-Eye study.

"There's a critical need to be able to treat patients less frequently," Regeneron CEO Leonard Schleifer tells Bloomberg. "This treatment is by direct injection into the eye; it's not like taking a pill." Regeneron and Bayer are expected to file for approvals in Europe and the U.S. in the next few months.

While Roche earns $1.2 billion a year from Lucentis, which is chemically similar to Avastin, most ophthalmologists prefer to use the much cheaper Avastin. A single dose of Lucentis costs $1,593, while Avastin is $42.

- here's the story from Bloomberg
- check out the Wall Street Journal report