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LX201 LX201 is a silicone matrix ocular implant that provides sustained release of cyclosporine A (CsA) locally to the eye over the course of one year. LX201 is implanted episclerally (beneath the connective tissue covering the white of the eye) in a minimally invasive procedure. The implant is being developed clinically for the prevention of rejection in corneal transplantation. Local delivery of CsA through LX201 potentially offers significant benefits in the treatment of corneal transplantation due to: · increased safety resulting from the absence of systemic toxicity of CsA, in particular of renal toxicity as, based on animal studies, LX201 does not produce measurable systemic levels; · increased efficacy as, based on animal studies, LX201 can establish continuous and relatively high therapeutic levels of CsA – higher than can be established by either oral doses or topically; and · increased patient compliance as dosing cannot be missed throughout the first year after transplantation. The main feature of the implant lies in the finding from animal studies that the local concentration of cyclosporine A, delivered episclerally, exceeds that achievable with systemic delivery or with topical application in the form of eye drops. It is believed that these higher doses applied in a sustained fashion are needed for reliable activity of the drug. If approved this product would be the first drug indicated for the prevention of rejection in high-risk cornea transplants. Lux Biosciences is currently enrolling patients into pivotal clinical trials. Details of the LUCIDA (LUx Corneal Transplant Implant Development and Advancement of Therapy) clinical trials can be found at www.clinicaltrials.gov
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