Lux Biosciences Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to two of the company's investigational therapeutics.
The first LX211, is a next-generation calcineurin inhibitor intended for the treatment of non infectious posterior, intermediate and panuveitis. The second, LX201, is a cyclosporine A (CsA)-eluting silicone matrix ocular implant for the prevention of rejection in corneal transplantation.
Orphan drug designation is a special status for diseases or conditions affecting fewer than 200,000 patients in the United States, granted by FDA upon request by a sponsor. Orphan drug designation qualifies the sponsor for exclusive US marketing rights for seven years if the company is first to receive marketing approval. The designation also positions Lux Biosciences to benefit from certain tax credits and waives the company's obligation to pay FDA application user fees for these products as required by the Prescription Drug User Fee Act (PDUFA).
"We are pleased to receive Orphan Drug designation from the FDA for these two late-stage products in our pipeline," said Ulrich Grau, president and chief executive officer of Lux Biosciences. "Both LX211 and LX201 have the potential of establishing new treatment paradigms in these two indications of high medical need. The only drugs currently approved in uveitis are steroids, and no drug has been approved to prevent rejection in corneal transplantation."
Lux Biosciences plans to begin enrolling patients in pivotal clinical trials for LX211 in early January 2007. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, an autoimmune disease characterized by chronic inflammation of the eye. Lux Biosciences also expects to initiate pivotal trials of LX201 in the corneal transplant setting in the first quarter of 2007.
LX211 is a next-generation calcineurin inhibitor to which Lux Biosciences has an exclusive worldwide license for ophthalmic indications from Isotechnika Inc, of Edmonton, Canada.
LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year.