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Lux
Biosciences’ Presentations at ARVO Highlight Both Topical and Polymer --
New Development Programs in Dry Eye and Other Inflammatory Ocular Diseases
JERSEY CITY, N.J. (April 28, 2008): Next generation polymer technologies for the controlled delivery of drugs and tailor-made product concepts for topical delivery to the eye offer major market opportunities for new and/or improved treatments for a variety of chronic inflammatory ocular conditions, said Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases. Company scientists and collaborators are this week presenting data on a proprietary topical product and new bioerodible polymer/drug approaches for the treatment of dry eye and other inflammatory eye diseases at the 2008 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), which is taking place from April 27 – May 1 in Fort Lauderdale, Florida. “Some 15 – 20 million people in North America and Europe are affected by chronic inflammatory diseases of the eye, which include such conditions as dry eye, keratoconjunctivitis, blepharitis and uveitis,” said Ulrich Grau, Ph.D. Lux Biosciences President and Chief Executive Officer. “The ophthalmic disease treatment community has a major need for local delivery of immunosuppressive therapy that is efficacious, well-tolerated and suitable for long-term use.” “Lux has licensed Isotechnika, Inc.’s next generation calcineurin inhibitor, voclosporin, for ophthalmic indications – the oral form of which (LX211) is currently in phase 3 clinical development in uveitis. By combining this molecule with innovative delivery technologies, such as mixed micelles or bioerodible polymers, we can deliver therapeutic concentrations of drug directly to the eye in a targeted and sustained fashion, offering the potential to greatly improve treatment for these widespread ocular conditions.” Prof. Ashim Mitra and colleagues from the University of Missouri – Kansas City, in collaboration with Lux Biosciences, will present a poster on the development of a clear, mixed micellar formulation product (LX214) for the treatment of dry eye syndrome and potentially other relevant ocular diseases. Of note, the preparation is a clear fluid and contains relatively high concentration (0.2%) of the drug. The researchers investigated different agents to tailor the formulation viscosity (ranging from 0.11 to 0.17 poise), thereby increasing the drug residence time in the eye. Mixed micellar size was 12 – 18 nm. LX214 formulations were well tolerated and did not produce irritation in animal eyes, as opposed to the comparator 0.05% CsA emulsion (Restasis®). LX214 was also efficacious in a preliminary study in a dog model of keratoconjunctivitis sicca (KCS). Dr. Grau noted that LX214 is currently in late stages of preclinical development and was expected to reach the clinic during 2008. Prof. Joachim Kohn and colleagues from the New Jersey Center for Biomaterials of Rutgers, The State University of New Jersey, and Lux Biosciences will also present orally on the development of a bioerodible insert for ocular delivery of voclosporin. The inserts under investigation were created from polymers selected from a large combinatorial library of bioerodible polyarylates and polycarbonates, developed by the Rutgers University researchers and licensed to Lux Biosciences for ophthalmic use. When formulated with drug, inserts employing these polymers exhibit a new hybrid mechanism of drug release that is capable of sustained drug delivery from 6 to 24 months. As such, these drug/polymer combinations have potential clinical implications for the treatment of a variety of immune-mediated ophthalmic conditions. Of note, the insert will provide sustained, near-constant levels for its entire lifetime, which has the potential to translate into improved efficacy when compared to discontinuous dosage forms, such as oral capsules or drops. The prototype implants are very small, owing to the fact that the active ingredient is very potent. “We believe that our two product concepts for chronic inflammatory ocular surface diseases have enormous potential given the very large numbers of patients involved,” said Dr. Grau. “Moreover, with these two product concepts we are in a position to segment this market and provide tailored products that specifically address the needs of different patient populations. Furthermore, Lux Biosciences is employing the polymer technologies in the development of further products for our own internal pipeline, and we are also in partnering discussions for applications outside our own field of interest.” About Lux BiosciencesLux 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:
For more information on Lux Biosciences, please visit the company’s website at http://www.luxbio.com. ### CONTACTS:
Lux
Biosciences, Inc.
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