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Dry Eye Treatment Fails Late-Stage Trial
Phase III endpoints elude monoclonal antibody (December 30)
Disappointing results have been reported from a 24-week, placebo-controlled phase III study involving 237 patients with moderate-to-severe dry eye syndrome who were treated with CF101 (OphthaliX Inc.), an A3 adenosine receptor agonist. The patients were randomly assigned to receive two oral doses of CF101 (0.1 mg or 1.0 mg) or placebo for 24 weeks.
In the study, CF101 did not meet the primary efficacy endpoint of complete clearing of corneal staining or the secondary efficacy endpoints.
CF101 is being developed for the treatment of ophthalmic indications, including dry eye syndrome (phase III), glaucoma (phase II), and uveitis (initiating phase II). The antibody is also being developed for the treatment of autoimmune inflammatory diseases, including rheumatoid arthritis (phase IIb) and psoriasis (phase II/III).
Source: OphthaliX Inc.; December 30, 2013.