Lux Biosciences granted FDA fast track designation for corneal transplant rejection drug
Click Here to Manage Email Alerts
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.