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Lux Granted Fast Track Designation For LX201 For Corneal Transplant Rejection

JERSEY CITY, N.J. (JANUARY 30, 2008): Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye to prevent corneal transplant rejection. LX201 is currently being tested in the one-year pivotal LUCIDA clinical trial program, comprising two controlled studies investigating the use of LX201 in patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation. 

“With this Fast Track designation, we can more rapidly work to provide a much needed therapy to patients,” commented Ulrich Grau, PhD, president and chief executive officer of Lux. “If successful, LX201 would become the first treatment available for the prevention of corneal transplant rejection.” 

The fast track drug development program is designed to promote the development of drugs to treat life-threatening or very serious conditions and requires that the drug demonstrate the potential to address unmet medical needs. Sponsors of products in fast track drug development programs may be considered for one or more of the following procedures regarding marketing applications:

• Priority review of NDAs and BLAs
• Submitting of portions of an application, and
• Accelerated Approval

About LX201 

LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year. Cyclosporine A is used widely as systemic therapy for the prevention of rejection following kidney and other solid organ transplantation. LX201 is implanted under the eyelid into the episcleral space (the area beneath the transparent tissue covering the white of the eye) in a minimally invasive procedure. Lux Biosciences is evaluating clinically the implant for the prevention of rejection in corneal transplantation. LX201 has received Orphan Drug status in both the United States and Europe.

About Lux Biosciences

Lux Biosciences, Inc. is a privately held biotechnology company focused on ophthalmic diseases. The company has a staged product portfolio of potentially first-in-class therapies distinguished by their short-term path to commercialization and potential to generate high revenue growth. The portfolio includes:

• Two Phase III clinical-stage projects including: i) LX211, the oral formulation of a next-generation calcineurin inhibitor developed as steroid sparing therapy for the treatment of non-infectious uveitis, and ii) LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for the prevention of rejection cornea transplant recipients. Both the LUMINATE pivotal clinical program for LX211 for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LX201 for the prevention of corneal transplant rejection were initiated in early 2007 and include sites in North America and Europe.

• LX214, a novel topical eye drop formulation currently in IND-enabling studies with a target date for entry into the clinic in mid 2008.  LX214 is based on Lux’s proprietary next-generation calcineurin inhibitor and is targeted towards other chronic inflammatory diseases of the eye, most notably dry eye syndrome, blepharitis and atopic keratoconjunctivitis.

• Several earlier stage projects based on proprietary product-enabling bio-erodible polymer technologies that facilitate targeted and sustained delivery of molecules to the eye.

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CONTACTS:

Lux Biosciences, Inc.
Ulrich Grau, Ph.D.
+1 201 946 0221
Ulrich.grau@luxbio.com

Kureczka/Martin Associates (media)
Joan Kureczka
+1 415-821-2413
Jkureczka@comcast.net