The trial, known as MIRA-1, did not demonstrate a statistically significant difference in the mean change of best spectacle-corrected visual acuity between the treated and placebo groups at 12 months post-baseline.
Although the group treated with the Rheo System did demonstrate a positive response, the company blamed an “anomalous response of the control group” as the reason for the failure of the therapy to reach its primary efficacy endpoint.
The company is now in the process of evaluating the implications of the MIRA-1 study data on its application to the FDA for approval to market its Rheo System in the US.
OccuLogix is 51% owned by TLCVision, North America’s premier eye care services company.