OccuLogix Reports Positive MIRA-1 Analysis Results.TORONTO -- RHEO(TM) Procedure Shown to Preserve or Restore Vision of Patients with Dry AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. OccuLogix, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :RHEO)(TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :RHE RHE Rothana Heavy Engineering (Star Wars) RHE Remote Hellfire Electronics RHE Runs, Hits, Errors (baseball scoring) RHE Reference Hydrogen Electrode RHE Radiation Hazard Effects ) today provided an update of MIRA-1, the Company's recently completed pivotal (phase III) clinical trial using its RHEO(TM) System to treat the dry form of age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. ("Dry AMD"). On February 3, 2006, OccuLogix announced that a preliminary analysis of MIRA-1's intent-to-treat ("ITT ITT Initial Teacher Training (UK) ITT I Think That ITT Invitation To Tender ITT Individual Time Trial (professional cycling) ITT Intention-To-Treat ITT In This Thread (forums) ") 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 ETDRS Early Treatment Diabetic Retinopathy Study BCVA BCVA Best Corrected Visual Acuity BCVA British Cattle Veterinary Association (Gloucestershire, UK) ") 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. Over the course of the past few weeks, the Company has completed an in-depth analysis of the study data identifying subjects that were included in the ITT population but who deviated from the protocol as well as those patients that had documented losses or gains in vision not related to retinal disease (e.g. cataracts, YAG YAG n. A hard synthetic yttrium aluminum garnet used in laser technology and as a gemstone. [y(ttrium) + a(luminum) + g(arnet)1.] capsulotomies, etc.). Those subjects in the ITT population who met the protocol requirements subsequently defined this modified per-protocol population. In this analysis, eyes treated with the RHEO(TM) procedure 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 following table presents a summary of the ETDRS BCVA changes observed in the modified per-protocol analysis of MIRA-1:
Treatment Group Placebo Group
(n equals 69) (n equals 46)
Vision improvement greater or equal to:
1 line 46.4% 19.6%
2 lines 27.5% 8.7%
3 lines 8.7% 2.2%
Vision loss greater or equal to:
1 line 11.6% 23.9%
2 lines 5.8% 6.5%
3 lines 2.9% 2.2%
A graphical comparison of the MIRA-1 modified per-protocol analysis to the MIRA-1 Interim Analysis can be found at http://www.rheo.com/pdfresources/mira1/mira1pp.pdf. With respect to those in the MIRA-1 modified per-protocol population that had pre-treatment vision worse than 20/40, 50.0% of RHEO(TM) treated eyes improved after treatment to 20/40 or better and would be able to qualify for a drivers license 12 months post-baseline, compared to 20.0% of Placebo eyes. MIRA-1 data support historical clinical and commercial experience with respect to the safety of the RHEO(TM) procedure, with observed treatment side-effects being generally mild, transient and self-limiting. "Prior to the development of the RHEO(TM) procedure, there hasn't been a potential treatment for Dry AMD beyond vitamin therapy," said Dr. Lawrence Yannuzzi, Professor of Clinical Ophthalmology at Columbia University and Vice-Chairman, Department of Ophthalmology and Director of the Retinal Research Center at the Manhattan Eye, Ear and Throat Hospital Manhattan Eye, Ear and Throat Hospital (MEETH) is one of the oldest and most prestigious specialty hospitals in the world. Founded in 1869, MEETH is a subsidiary of Lenox Hill Hospital and is located on the Upper East Side of Manhattan at 210th East 64th Street. . "These results, while not yet conclusive, are very encouraging and may offer patients living with Dry AMD hope for the future." Elias Vamvakas, OccuLogix's Chairman & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. commented, "We were pleased to observe that the results of this analysis of MIRA-1 are statistically significant and that the excellent safety profile of the RHEO(TM) procedure, already established by the thousands of procedures captured in the international RheoNet Registry, was maintained." "Our goal was to provide clinical data to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. on 150 subjects that had completed 12 months follow-up. This modified per-protocol study population, however, totaled 115 at 12 months," Vamvakas continued. "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(TM) System in the United States. While the Company cannot predict what the FDA will require for approval, we believe that it is more likely than not that further study will be required. We will, of course, continue to provide further updates as they become available." About AMD 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. The macula is responsible for our ability to see with enough detail to read, drive, watch television and perform other activities that require focused, straight-ahead vision, as well as providing information that allows us to perceive colors; thus, allowing one to maintain independence in daily activities. There are two types of AMD - "dry", or non-exudative, and "wet", or exudative exudative of or pertaining to a process of exudation. exudative diathesis a disease of young pigs and chickens caused by a nutritional deficiency of vitamin E. Characterized by severe edema of the subcutaneous tissues. . Dry AMD, the most common form of the disease, currently afflicts approximately 13.0 to 13.5 million people in the United States, representing approximately 85% to 90% of all AMD cases in the country. Currently, there is no FDA approved treatment for Dry AMD. About the RHEO(TM) Procedure The RHEO(TM) procedure is a specific method of apheresis apheresis (əfĕr`əsĭs), or hemapheresis (hē'məfĕr`əsĭs), any procedure in which blood is drawn from a donor or patient and a component (platelets, plasma, or white blood - a treatment in which a patient's blood is drawn outside the body and specific compounds are removed before being returned to the body. Apheresis, which is similar in principle to blood donation, has been used for decades to treat a variety of illnesses, including excessively high cholesterol and rheumatoid arthritis. Japanese scientists developed the basis for the RHEO(TM) procedure in the 1970s while looking for a way to treat high cholesterol. About 10 years later, researchers at the University of Cologne The University of Cologne (German Universität zu Köln) is one of the oldest universities in Europe and, with over 44,000 students, the largest university in Germany. in Germany used a newly developed filter, today called the RHEO(TM) filter, in a treatment study for eye conditions characterized by impaired microcirculation microcirculation /mi·cro·cir·cu·la·tion/ (-sir?ku-la´shun) the flow of blood through the fine vessels (arterioles, capillaries, and venules).microcirculato´ry mi·cro·cir·cu·la·tion n. of the retina. The treatment was especially successful in patients who had AMD. Based on those results, experts conducted years of clinical research in order to further develop the RHEO(TM) procedure into a treatment for Dry AMD. About the Study MIRA-1 is a multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. (2:1), double-masked and placebo-controlled study of patients with intermediate-to-late stage Dry AMD designed to evaluate the safety and efficacy of the RHEO(TM) procedure. Each patient in MIRA-1 received either eight RHEO(TM) procedures or eight placebo procedures respectively over ten weeks. Patients were followed out to 12 months post-baseline to evaluate any sustained benefit of the treatment for the RHEO(TM) procedure population and the continuing natural course of vision change in the Placebo population. Modified Per-Protocol The modified per-protocol population excludes patients that didn't meet the original MIRA-1 protocol as well as those patients with ophthalmic changes not associated with the retina, including phakic patients who developed cataracts and/or had cataract removal during follow-up, pseudophakic patients who developed posterior capsule haze or had Nd:Yag capsulotomies during follow-up and patients with greater than or equal to 1.5 diopter Diopter A measure of the power of a lens or a prism. The diopter (also called dioptrie) is usually abbreviated D. Its dimension is a reciprocal length, and its unit is the reciprocal of 1 m (3.28 ft). change in refraction refraction, in physics, deflection of a wave on passing obliquely from one transparent medium into a second medium in which its speed is different, as the passage of a light ray from air into glass. based on the MRSE MRSE Methicillin-Resistant Staphylococcus Epidermidis MRSE Message Retrieval Service Element MRSE Mean Radial Spherical Error MRSE Metal Resonance Sound Effect (manifest refraction spherical equivalent) from baseline, all of which are reflective of changes in BCVA (both positive and negative) that are not associated with AMD. Forward-Looking Statements This press release may contain forward-looking statements. These statements relate to future events and are subject to risks, uncertainties and assumptions about the company. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement, including the factors detailed in our filings with the Securities and Exchange Commission and Canadian regulatory authorities, including our Registration Statement on Form S-1. We do not undertake to update any forward-looking statements. OccuLogix, Inc. (NASDAQ:RHEO) (TSX:RHE) |
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