MOUNTAIN VIEW, Calif., Feb 24, 2005 /PRNewswire-FirstCall via COMTEX/ -- IRIDEX Corporation (Nasdaq: IRIX) today announced a significant clinical benefit in a subset of patients with wet age-related macular degeneration (AMD) who were treated with the transpupillary thermotherapy (TTT) laser protocol when compared to the sham treated control group in the TTT4CNV Clinical Trial. The results showed that in a subgroup of patients with baseline visual acuity of 20/100 or worse, 22% of treated eyes improved vision by one or more lines compared with none of the eyes in the untreated control group. Furthermore, at 18 months, there was a 2 line benefit in preserving vision in this subgroup when compared to sham treated eyes. Specifically, TTT treated eyes on average lost 2 lines of visual acuity while sham treated eyes lost 4 lines. Both of these findings were statistically significant.
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, will be presenting these results Friday, February 25 at The Macula Society Meeting in Key Biscayne, Florida.
Dr. Reichel commented, "These subgroup results are very important. TTT clearly benefits patients with vision that is 20/100 or worse. Within the TTT4CNV Clinical Trial about 42% of the patients enrolled had baseline vision of 20/100 or worse. On average, in this group of patients, the TTT treated patients lost two lines less than the sham treated group at 18 months. Remarkably, at 18 months, one-fifth of treated patients showed some improvement in vision compared to their vision prior to the TTT treatment. This compares to no vision improvement for patients in the sham treated control group. These results support a role for TTT in the treatment of a significant fraction of patients with occult wet AMD worldwide."
Theodore A. Boutacoff, President and CEO of IRIDEX said, "We are excited about these results and the significant contribution they can make in the clinical care of patients with occult wet AMD. TTT has the potential to offer physicians a clinically effective, cost efficient procedure that is easily incorporated into practice and can benefit many patients since it targets the early occult stage of the disease."
Conference Call
IRIDEX and Dr. Reichel will conduct a conference call to discuss the TTT4CNV Clinical Trial results on Monday, February 28 at 1:30 p.m. ET, 10:30 a.m. PT. Interested parties may access the live conference call via telephone by dialing 800-265-0241 US or 617-847-8704 International and entering code 85535615 or visit the Company's website at www.iridex.com. A telephone replay will be available beginning on February 28, 2005 through March 7, 2005 by dialing 888-286-8010 US or 617-801-6888 International and entering code 37300186. In addition, an archived version of the webcast will be available later in the day on February 28, 2005 on the Company's website at www.iridex.com.
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 milliWatts 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. TTT is a large spot size, low irradiance, long exposure, infrared (810 nm) laser photocoagulation protocol. The protocol uses the Company's IRIS Medical OcuLight SLx laser and Large Spot Slit Lamp Adapter.
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
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Act of 1934, as amended, relating to the role of TTT in the treatment of occult wet AMD, the potential to incorporate its use in patient care and the potential benefits of its use. 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, the clinical rate of adoption of TTT for treatment of occult wet AMD, the experience of ophthalmologists in treating patients with TTT, the potential for variation in TTT treatment results across other patient populations or other studies, government regulatory procedures, and market acceptance of the Company's products. For additional risks, please see those contained in our Quarterly Reports on Form 10-Q and Annual Report on Form 10-K for the fiscal 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
Larry Tannenbaum, Chief Financial Officer, of IRIDEX Corporation, +1-650-940-4700
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