OccuLogix RHEO System study for dry AMD fails to meet endpoint

By Lisa Kerner

Erie, Pa., Feb. 3 - OccuLogix, Inc. said a preliminary analysis of the data from a pivotal phase 3 clinical trial (MIRA-1) using its RHEO System to treat the dry form of age-related macular degeneration shows the primary efficacy endpoint of the study was not met.

MIRA-1 did not demonstrate a statistically significant difference in the mean change of Best Spectacle-Corrected Visual Acuity applying the Early Treatment Diabetic Retinopathy Scale (ETDRS BCVA) between the treated and placebo groups at 12-months post-baseline, according to a company news release.

The treated group demonstrated a positive response as expected. An anomalous response of the control group is the principal reason that the primary efficacy endpoint was not met, the company said.

Certain subgroups demonstrated statistical significance in their mean change of ETDRS BCVA versus control. OccuLogix said it is undertaking further analysis of the study data and evaluating its implications on an application to the Food and Drug Administration for approval to market its RHEO System in the United States.

OccuLogix is a Toronto-based health care company.

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