RegeneRx Biopharmaceuticals’ RGN-259, a sterile, preservative-free eye drop, has been found effective against dry eye syndrome during Phase 2 clinical trial designed to assess the effect of RGN-259 on numerous signs and symptoms of dry eye.
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Conducted by ORA, the trial demonstrated the safety and efficacy of the drug in a number of key Controlled Adverse Environment (CAE)-related parameters.
The study, which did not meet the two selected primary outcome measures, also identified statistically important sign and symptom improvements attributable to RGN-259.
RegeneRx president and CEO J.J. Finkelstein said the trial has allowed them to identify specific dry eye signs and symptoms that could be targeted as primary outcome measures in future clinical trials.
"Along with other positive findings, reduction of exacerbation of corneal staining and ocular discomfort during CAE exposure correlate well with RGN-259’s reported mechanisms of action," J.J. Finkelstein added.
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