A Medical Device Daily
Eye care services company TLCVision (St. Louis) reported that OccuLogix (Toronto), of which TLCVision has 51% ownership, has completed a preliminary analysis of the data from MIRA-1, its recently completed Phase III clinical trial using its RHEO System to treat the dry form of age-related macular degeneration (AMD).
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, the company said. As expected, the treated group demonstrated a positive response. An anomalous response of the control group is the principal reason that the primary efficacy endpoint was not met.
OccuLogix said that some subgroups did demonstrate statistical significance in their mean change of ETDRS BCVA vs. control. Further analysis of the study data is being undertaken, according to the company.
OccuLogix said it is in the process of evaluating the implications of the MIRA-1 study data on its application to the FDA for approval.