Lux Biosciences begins phase 3 trials of cyclosporine A implant
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JERSEY CITY, N.J. Lux Biosciences has begun treating patients in two phase 3 clinical trials of LX201, a cyclosporine A-eluting implant, the company announced in a press release.
LX201 is a silicone matrix ocular implant, placed within the subconjunctival space, that steadily releases therapeutic doses of cyclosporine A locally for 1 year. Lux Biosciences is evaluating the device for preventing corneal transplant rejection. The two trials are investigating the efficacy of LX201 in patients at elevated immune mediated risk of corneal transplant graft rejection or loss, according to the release.
The company expects to enroll more than 400 patients in the trials, which are being conducted at approximately 35 centers in North America, Europe and India. Outcome measures include signs of rejection, such as increased corneal thickness or inflammation, and graft loss, at 1 year follow-up, the release said.