LUCIDA Phase III patient enrollment complete

Lux Biosciences (Jersey City, N.J.) has completed patient enrollment in the Phase III Lux Corneal Transplant Implant Development and Advancement of Therapy—dubbed LUCIDA—clinical trial program for Lumitect, formerly known as 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.

The LUCIDA clinical trial program is investigating the 1-year use of LX201 in 493 patients at elevated immune-mediated risk of rejection or graft loss subsequent to cornea transplantation. The program has three protocols: The two masked, placebo-controlled studies 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. The first includes 190 patients in the U.S. and Germany; the second includes 181 patients in India. A third protocol was discontinued after slow enrollment, but safety data from those who were enrolled will be used in the overall data.

Lux Biosciences expects data from the first of two pivotal LUCIDA studies later in 2009, while data from a second study would become available in the first half of 2010, the company said in a press release.

Lumitect is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for 1 year, the company said. 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. The device is implanted under the eyelid into the subconjunctival space. It has received Orphan Drug status in both the United States and Europe, and Fast Track status in the United States.

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