Lux Biosciences granted FDA fast track designation for corneal transplant rejection drug
JERSEY CITY, N.J. The U.S. Food and Drug Administration has granted Lux Biosciences fast track designation for LX201, a silicone matrix ocular implant designed to steadily release therapeutic doses of cyclosporine A to prevent corneal transplant rejection, the company announced in a press release.
LX201 is currently being tested in a 1-year clinical trial program, which involves two controlled studies investigating LX201 in patients at increased immune-mediated risk of either rejection or graft loss after corneal transplantation.
The fast track drug development program is designed to promote the development of drugs to treat life-threatening or serious conditions, and requires that the drug demonstrate the potential to address unmet medical needs.