Lux Biosciences Initiates Phase 1 Study of LX214, a Development Candidate for Dry Eye Syndrome

•  LX214 is Lux Biosciences’ Third Product Candidate to Enter Clinical Trials

•  Preclinical Profile Suggests that Drug Candidate Offers a Differentiated
Product for a Very Frequent Condition

JERSEY CITY, N.J. (February 17, 2009):  Lux Biosciences today announced that it has begun treating patients in a Phase 1 study with its third product candidate, LX214, a proprietary topical ophthalmic solution containing the next-generation calcineurin inhibitor voclosporin. The company is developing LX214 as a potential treatment for keratoconjunctivitis sicca, commonly known as dry eye syndrome (DES), and other chronic inflammatory ocular surface diseases.

“We are pleased with the progress of our program for LX214, which we advanced from inception into the clinic in 18 months, in parallel with our LX211 and LX201 phase 3 development programs,” said Ulrich Grau, Lux Biosciences President and Chief Executive Officer.

He noted that LX214 is a unique product that, based on preclinical data, is differentiated from the benchmark therapy by

• much higher drug levels of a 4 fold more potent calcineurin inhibitor in target tissues in the eye,

• the lack of irritation, and

• 24-hour therapeutic drug levels in the eye providing a rationale for once-a-day dosing.

“These features suggest that LX214 may demonstrate advantages over other treatment approaches in the very large dry eye indication,” Dr. Grau commented.

LX214 is Lux’s proprietary formulation of the next generation calcineurin inhibitor voclosporin, which is licensed for ophthalmic indications from Isotechnika Inc. (Edmonton, Canada). The product has been developed for topical ophthalmic use in collaboration with Professor Ashim Mitra at the University of Missouri, Kansas City. Unlike other topical dry eye products and product candidates with a similar mechanism of action, LX214 is a crystal clear, aqueous, mixed micellar formulation. In addition to the unique features of the formulation, LX214 contains a high concentration of voclosporin and, based on preliminary testing, appears to be non-irritating. Lux has filed for a patent covering LX214 with a priority date in 2007.The primary objective of the phase 1 study is to evaluate the safety and tolerability of LX214 when applied topically to the eye of healthy volunteers and subjects with keratoconjunctivitis sicca.


About Dry Eye Syndrome

Dry eye syndrome (DES) is a condition that includes a variety of disorders resulting in loss or breakup of the natural tear film, which maintains lubrication on the surface of the eye. Without this tear film, vision is impaired, the ocular surface may be damaged and patients may suffer severe ocular discomfort. Though the exact causes of DES are unknown, there is evidence supporting the link between reduced tear production and chronic inflammation of the ocular surface and lacrimal gland. Symptoms associated with dry eye syndrome account for up to 40% of all ophthalmologist visits and affect about 10 million people in North America and Europe. Though there are a variety of medications that palliate the symptoms of DES, there is still no cure for this debilitating disease. Currently available medications for DES leave substantial room for more effective and better-tolerated products.

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) LX201, 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 (Lux Corneal Transplant Implant Development and Advancement of Therapy) pivotal clinical program with LX201 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 and the data analysis is planned for Q1 2009.

• LX214 is Lux’s proprietary topical eye drop formulation that entered human clinical testing for dry eye syndrome in Q1 2009. Based on the next-generation calcineurin inhibitor voclosporin, 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