Additional Follow-up Data Presented
MOUNTAIN VIEW, Calif., May 3 /PRNewswire-FirstCall/ -- IRIDEX Corporation (Nasdaq/NMS: IRIX) today announced that additional follow-up data confirmed a significant clinical benefit in a group 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 (placebo) control group in the TTT4CNV Clinical Trial.
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 these results covering 305 participating patients today at the ARVO Meeting in Ft. Lauderdale, Florida.
These updated results confirmed and expanded upon the initial results reported in February 2005 that a subgroup of patients, who were enrolled into the study with baseline visual acuity of 20/100 or worse, benefited from TTT treatment. Within the TTT4CNV Clinical Trial, about 41% of the patients enrolled had baseline vision of 20/100 or worse. Specifically, at 12 months following treatment 23% of TTT treated eyes in this subgroup improved vision by one or more lines and 14% of TTT treated eyes improved vision by three or more lines compared with none of the eyes in the placebo treated control group. Furthermore, at 18 months, there was a 2 line benefit in preserving vision in this subgroup when compared to placebo treated eyes. Specifically, TTT treated eyes on average lost 2 lines of visual acuity while placebo treated eyes lost 4 lines. These findings were statistically significant.
Dr. Reichel commented, "These less than or equal to 20/100 subgroup findings indicate that TTT is beneficial compared to natural history in eyes with subfoveal occult CNV and best-corrected visual acuity of 20/100 or worse."
Theodore A. Boutacoff, President and CEO of IRIDEX said, "We are pleased that these results confirm that a group of patients suffering from wet AMD can benefit from TTT treatment, a clinically effective, cost efficient procedure that is easily incorporated into a retinal practice."
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 1, 2005 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- 05/03/2005
/CONTACT: Larry Tannenbaum, Chief Financial Officer, of IRIDEX
Corporation, +1-650-940-4700/
/Web site: http://www.iridex.com/
(IRIX)
CO: IRIDEX Corporation
ST: California
IN: HEA MTC BIO
SU: SVY
KG-EB
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2051 05/03/2005 09:30 EDT http://www.prnewswire.com
