OccuLogix reports positive MIRA-1 analysis results for macular degeneration

By Elaine Rigoli

Tampa, Fla., March 9 - OccuLogix, Inc. provided an update of MIRA-1, the company's recently completed phase 3 clinical trial using its RHEO system to treat the dry form of age-related macular degeneration (dry AMD).

The RHEO procedure is a specific method of apheresis, a treatment in which a patient's blood is drawn outside the body and specific compounds are removed before being returned to the body, according to a company news release.

On Feb. 3, OccuLogix announced that a preliminary analysis of MIRA-1's intent-to-treat (ITT) population had indicated that the study 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. As expected, the treated group demonstrated a positive response. However, there was an anomalous outcome of the control group, the release said.

Over the course of the past few weeks, the company said it has completed an in-depth analysis of the study data identifying subjects who were included in the ITT population but who deviated from the protocol, as well as those patients who had documented losses or gains in vision not related to retinal disease.

Those subjects in the ITT population who met the protocol requirements subsequently defined this modified per-protocol population.

For eyes treated with the RHEO procedure, the patients demonstrated a mean vision gain of 0.8 lines of ETDRS BCVA at 12 months post-baseline compared to a mean vision loss of 0.1 lines of ETDRS BCVA in the eyes in the placebo group. The result was statistically significant (repeated measure p value equals 0.0147), the release said.

Those in the modified per-protocol population with pre-treatment vision worse than 20/40, 50.0% of RHEO-treated eyes improved after treatment to 20/40 or better and would be able to qualify for a driver's license 12 months post-baseline, compared to 20.0% of placebo eyes, the release said.

"Our goal was to provide clinical data to the FDA on 150 subjects that had completed 12 months' follow-up. This modified per-protocol study population, however, totaled 115 at 12 months," said Elias Vamvakas, chairman and chief executive officer, in a statement.

"We plan on meeting with the FDA in the second quarter to discuss what impact the MIRA-1 study results and this analysis will have on our application to market our RHEO system in the United States."

Age-related macular degeneration causes damage to the macula - the light-sensitive cells at the center of the retina at the back of the eye. There are two types of AMD, "dry" (non-exudative) and "wet" (exudative).

Dry AMD, the most common form of the disease, currently afflicts about 13 million to 13.5 million people in the United States, representing about 85% to 90% of all AMD cases in the country, the release said.

Currently, there is no FDA-approved treatment for dry AMD.

Occulogix, based in Toronto, Ont., is a health care company that develops new medical therapies.

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