This article is more than 5 years old. Information may no longer be current.
RegeneRx dry eye treatment misses primary outcomes in phase 2 trial
Click Here to Manage Email Alerts
ROCKVILLE, Md. - A phase 2 clinical trial for RegeneRx Biopharmaceuticals' sterile, preservative-free eye drop RGN-259 for dry eye failed to meet the two primary outcome measures chosen before the trial but demonstrated other statistically significant results, according to a company press release.
"We believe these data are very encouraging. This trial has allowed us to identify specific dry eye signs and symptoms that could be targeted as primary outcome measures in future clinical trials," J.J. Finkelstein, RegeneRx's president and CEO, said in the release.
The analysis examined the reactions of 72 patients to the drug vs. placebo over a 30-day span.
According to the release, the treatment demonstrated a reduction from baseline in central corneal fluorescein staining compared with placebo at the 24-hour recovery period (P = .0075); reduction from baseline in exacerbation of superior corneal fluorescein staining in the chamber as compared with placebo (P = .021); and reduced exacerbation of ocular discomfort at day 28 compared with placebo (P = .0244).
In a separate release on the trial, RegeneRx noted that meeting primary outcomes chosen before an exploratory trial is less significant than discovering statistically significant outcomes that may be used as outcomes in phase 3 trials.