MOUNTAIN VIEW, Calif., Oct. 22 /PRNewswire-FirstCall/ -- IRIDEX Corporation (Nasdaq: IRIX) announced today that Dr. Elias Reichel presented preliminary two-year results from the TTT4CNV Clinical Trial for occult neovascular (wet) age-related macular degeneration (AMD). A total of 303 patients were enrolled in the study. Patients who were treated in the study with the Transpupillary Thermotherapy (TTT) laser protocol were compared to sham treatment. Results were presented today at the Retina Subspecialty Day Program during the annual meeting of the American Academy of Ophthalmology and that the intent-to-treat evaluation of the primary visual outcome data showed that TTT, as applied in this trial, did not result in a significant beneficial effect relative to sham.
Dr. Elias Reichel, Study Chairman of the TTT4CNV Clinical Trial and Associate Professor of Ophthalmology at the New England Eye Center, Tufts University School of Medicine, presented the data. At two years 47% of eyes avoided modest or severe vision loss compared to 43% of sham eyes, which was not statistically significant. Follow-up at 18 and 24 months showed an advantage of approximately 4 letters in TTT treated eyes; though this trend was not significant.
Additionally, it was reported that 11% of patients who were treated with TTT compared to 3% of patients who received sham showed improvement (greater or equal to 2 lines increase) from baseline when evaluated at one year. This secondary outcome was statistically significant.
Dr. Reichel stated, "Further analysis of this subgroup of patients who improved vision may yield information regarding those patients who respond to TTT. Specifically this subgroup of patients may have certain characteristics that result in a high likelihood of improvement or stabilization over time."
Safety results were also presented. Some patients, both in the treatment and sham groups, showed severe loss of vision at the one-month follow-up visit. This occurred in 5% of TTT treated eyes compared to 1% of sham eyes. This finding was not statistically significant.
Dr. Reichel concluded, "Given the fact that the Executive Committee was unmasked to the outcome data only recently, there are a number of questions for which analyses remain to be done. Specifically, careful inspection of baseline characteristics between groups and a per protocol analysis that evaluates the subset of enrolled patients who met all key eligibility criteria needs to be done."
Theodore A. Boutacoff, President and CEO of IRIDEX said, "We are disappointed that these preliminary results did not demonstrate a significant difference compared to sham when these patients were treated following the TTT4CNV dosing protocol. We are encouraged that a number of patients experienced a significant improvement in vision and look forward to the comprehensive analysis of the study data that may provide clarity into the patients who responded well to TTT. We remain optimistic about this therapy in light of the difficulties and inconsistencies in treating this devastating condition and the economic burden given the large numbers of newly affected patients."
About the TTT4CNV Clinical Trial
The TTT4CNV Clinical Trial is a multi-center, prospective, double-masked, placebo-controlled clinical trial conducted at 22 centers in the United States. The trial was designed to look at eyes with wet AMD and randomized eyes with small (less than or equal to 3 mm diameter) subfoveal occult membranes and symptomatic vision (ETDRS visual acuity between 20/50 and 20/400). In all TTT treated eyes laser energy was applied at 800 mW with a 3 mm spot size for 60 seconds with the IRIS Medical(R) OcuLight(R) SLx 810 nm laser and Large Spot Slit Lamp Adapter. Results were compared to sham treated (placebo) eyes. One retreatment was permitted at 3 months during the follow-up period at the physician's discretion. The trial was physician initiated, supported by IRIDEX and performed within the FDA cleared indications for the OcuLight infrared laser system.
About IRIDEX
IRIDEX Corporation is a leading worldwide provider of semiconductor-based laser systems for the ophthalmology and dermatology markets. IRIDEX products are sold in the United States through a direct sales force and internationally through a network of independent distributors into more than 100 countries. For further information, visit the Company's website at www.iridex.com.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Act of 1934 relating to the outcome of any further analysis of the study data, further validation in treating wet AMD with TTT, the size of the patient population that can benefit from the TTT procedure and the effectiveness of TTT. These statements are subject to risks and uncertainties and actual results could differ materially from those projected in the forward-looking statements based on, among other things, further analysis of the study data may not yield any statistically significant identifiable group that improved from the TTT treatment. For additional risks that may affect the Company, please see a detailed description of these risks contained in our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended January 3, 2004 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
SOURCE IRIDEX Corporation
-0- 10/22/2004
/CONTACT: Larry Tannenbaum, Chief Financial Officer of IRIDEX,
+1-650-940-4700/
/Web site: http://www.iridex.com/
(IRIX)
CO: IRIDEX Corporation
ST: California
IN: CPR HEA MTC
SU: SVY
JB-KG
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1212 10/22/2004 10:50 EDT http://www.prnewswire.com
