Lux Biosciences Completes Patient Enrollment in LUCIDA Phase 3
Program for Prevention of Corneal Transplant Rejection

JERSEY CITY, N.J., March 18, 2009 – Lux Biosciences today announced the completion of enrollment in the company’s phase 3 LUCIDA (LUx Corneal Transplant Implant Development and Advancement of Therapy) clinical trial program for LUMITECT™ (LX201). LX201 is a silicone matrix ocular (episcleral) implant designed to provide the continuous release for one year of therapeutic levels of cyclosporine A locally to the eye to prevent corneal transplant rejection.

“We are very gratified to have reached this important developmental milestone for LUMITECT, a therapeutic product candidate that has the potential to address a major medical need for which there are no currently approved treatments,” said Ulrich Grau, Ph.D., President and Chief Executive Officer of Lux Biosciences. “Moreover, we have accomplished this goal, as well as the completion of our phase 3 LUMINATE program in uveitis for LUVENIQ™ and the start of Phase 1 testing for a third product, LX214, that was developed de novo for dry eye, in less than three years from our company’s founding.”

Dr. Grau noted that Lux Biosciences expected data from the first of two pivotal LUCIDA studies later in 2009, while data from the second study would become available in the first half of 2010.

The LUCIDA clinical trial program is investigating the one-year use of LX201 in patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation. The program has recruited a total of 493 patients in 3 protocols. The two masked, placebo-controlled studies that are intended to support product registration are identical protocols in distinct geographic regions in which high-risk cornea transplant patients receive a LX201 implant at the time that penetrating keratoplasty is performed.

One of the two protocols recruited patients at 30 sites in the United States and Germany (N=190); this trial completed patient enrollment in July 2008. The second, identical protocol began in March 2008 and recruited patients at 9 sites in India (N=181), completing recruitment in March 2009. A third protocol, in which patients received LX201 subsequent to having experienced a rejection episode, was discontinued owing to slow recruitment; however this third study will provide additional safety information. In each protocol, subjects are randomized to receive implants containing two different dose levels of active drug or placebo. The endpoint for all three protocols is the incidence of rejection episodes or graft loss at 1 year for each dose group versus placebo.

About LUMITECT (LX201)
LUMITECT is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year. Two different dose level implants are being studied, a 0.75 inch implant that elutes approximately 20-25 µg/day of Cyclosporine A, and a 0.5 inch implant that elutes approximately 15 µg/day of Cyclosporine A. (Cyclosporine A is used widely as systemic therapy for the prevention of rejection following kidney and other solid organ transplantation) LUMITECT is implanted under the eyelid into the subconjunctival space (the area beneath the transparent tissue covering the white of the eye) in a minimally invasive procedure. Lux Biosciences is evaluating the implant clinically for the prevention of rejection in corneal transplantation. LUMITECT has received Orphan Drug status in both the United States and Europe, and Fast Track status in the United States.

About Cornea Transplantation
Approximately 32,000 corneas are transplanted each year in the United States and an additional 22,000 in Europe. While the cornea is generally a tissue that is not vascularized -- does not contain blood vessels -- and thus is less prone to acute rejection, the rate of rejection reactions in high risk corneal transplant patients is in the range of 50 percent over one year. This is comparable to the rate of rejection experienced in kidney transplantation in the 1970’s, prior to the introduction of modern immunosuppressive therapies.

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 3 clinical-stage projects including: i) LUVENIQ™, the oral formulation of a next-generation calcineurin inhibitor (voclosporin) developed as steroid-sparing therapy for the treatment of sight-threatening non-infectious uveitis, and ii) LUMITECT™, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for the prevention of rejection in corneal transplant recipients. Both the LUMINATE pivotal clinical program for LUVENIQ for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LUMITECT™, for the prevention of corneal transplant rejection were initiated in early 2007 and include sites in North America, Europe and India. Enrollment in the LUMINATE program was completed in June 2008. Enrollment in the LUCIDA program was completed in March 2009.

• LX214 is a novel and proprietary topical eye drop formulation that entered human clinical testing for dry eye syndrome in February 2009. Based on Lux’s proprietary next-generation calcineurin inhibitor, LX214 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.

For more information on Lux Biosciences, please visit the company’s website at www.luxbio.com.

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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