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

March 19, 2009

Lux Biosciences, a privately held biotechnology company focused on ophthalmic diseases, announced yesterday the completion of enrollment in the company’s phase 3 LUCIDA (LUx Corneal Transplant Implant Development and Advancement of Therapy) clinical trial program for LUMITECTTM (LX201).

LUMITECT is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year to prevent corneal transplant rejection. 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 (note: cyclosporine A is used widely to prevent 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.

The LUCIDA clinical trial program is investigating the one-year use of LUMITECT in patients at elevated risk of rejection or graft loss subsequent to cornea transplantation. The program has recruited a total of 493 patients in 3 protocols in which high-risk cornea transplant patients receive a LUMITECT implant at the time that penetrating keratoplasty is performed.

Lux Biosciences also announced completion of their phase 3 LUMINATE program for LUVENIQTM (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 the start of Phase 1 testing for a third product, LX214 (a proprietary topical eye drop formulation targeted towards chronic inflammatory diseases of the eye, most notably dry eye syndrome, blepharitis and atopic keratoconjunctivitis).




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