IRIDEX Announces Results of Study Demonstrating the Delay in the Progression of Dry AMD to Wet AMD.

Business Editors/Health & Medical Writers

MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 1, 2000

IRIDEX Corporation (Nasdaq:IRIX) announced that a clinical study presented at the annual Association for Research in Vision and Ophthalmology (ARVO) meeting held last month in Fort Lauderdale, Florida, concluded that eyes that responded to a grid infrared (810 nm) diode laser treatment using the Company's laser system demonstrated a reduced incidence of progression from dry AMD to the more vision threatening wet form.

The paper presented by R. Joseph Olk, M.D. reported the 4-year results of a pilot study which was conducted at four clinical centers in the U.S. The study included 229 eyes of 152 patients with dry AMD that were randomized to either receive a single treatment with the Company's IRIS Medical OcuLight SLx infrared laser photocoagulator or be observed in a control group. The 4-year results confirmed the pilot study's 2-year results, which were published in the November 1999 issue of Ophthalmology.

The 4-year data confirmed that the accumulated deposits (drusen) associated with the early stages of dry AMD were significantly reduced following a single treatment in 78% of the eyes compared to 8% of observed eyes. In addition, consistent with the 2-year results, visual acuity was significantly improved by this treatment with an improvement of two or more lines in 34% of selected treated eyes, compared with none in the control group. All eyes with visual acuity improvement had drusen reduction.

The study indicated that eyes which had a reduction in drusen (responder) progressed to wet AMD at a lower rate than eyes which did not respond to treatment (non-responder). During the 4-year follow-up period of the 35 eyes that progressed to wet AMD, 34 were either in the observation group or non-responders to treatment.

Dr. Olk, Director of The Retina Center of St. Louis County, St. Louis, commented, "Since 34 of 35 eyes which progressed to wet AMD were either in the observation group or were eyes which did not respond to treatment, and since nearly 80% of the treated eyes did respond to the treatment, this strongly suggests the possibility of an effective prophylactic treatment. This treatment is important because wet AMD is the major cause of AMD-related blindness, and halting or delaying the progression of the disease from the dry form to the wet form would be a great contribution toward reducing the incidence of blindness in our society."

Dry AMD patients with bilateral soft drusen (BSD) represent a majority of all new AMD cases. Stopping AMD at the dry stage would lessen the cases of severe vision loss. A paper published from the Scheie Eye Institute (Archives of Ophthalmology. 1998;116:1045-1052) evaluated the potential impact of effective prophylactic treatment for patients with BSD on progression to wet AMD and severe vision loss. The paper concluded that a treatment with a 10% efficacy would more than double the prevention of legal blindness in the BSD population compared to current therapy, while a 33% efficacy would more than halve the rate of legal blindness due to wet AMD in those dry AMD patients.

"In Dr. Olk's study, only one of the eyes that responded to the treatment developed wet AMD in 4 years," commented Theodore A. Boutacoff, President and Chief Executive Officer of IRIDEX, "suggesting that grid infrared (810 nm) diode laser treatment may have a high prophylactic efficacy. Given that there are about 50 million people worldwide with AMD with an incidence of about 5 million new cases each year, and since there is no effective treatment for preventing the progression toward legal blindness in a substantial number of these people, I believe these pilot study findings have important implications. The follow-on PTAMD Clinical Trial, sponsored by IRIDEX and currently enrolling patients, should provide definitive answers to where prophylactic treatment of dry AMD will fit within the treatment regimen for the disease."

IRIDEX's Commitment to AMD

IRIDEX continues to focus efforts on product and clinical procedure development that can help doctors treat the leading causes of blindness. Over the past eight years, IRIDEX has developed a number of treatments for AMD, a disease that affects about 50 million people worldwide. IRIDEX has developed five approaches to treating AMD, the leading cause of blindness in the western world. Two of these approaches are directed at treating the dry form of AMD, while three approaches are directed at treating the wet form (one wet approach uses a novel PDT agent in collaboration with Miravant Medical Technologies and Pharmacia Corporation). Therefore, unlike most companies who are developing a single approach to treat a specific stage of AMD, IRIDEX is developing and putting into practice a number of applications to treat AMD at the earliest stage where maximum vision is preserved. IRIDEX's laser systems are used in these new treatments being developed for AMD.

About IRIDEX

IRIDEX Corporation is the leading worldwide provider of semiconductor-based laser systems used to treat eye diseases for ophthalmology and skin lesions for dermatology. IRIDEX products are sold in the United States through a direct sales force and internationally through 60 independent distributors into 74 countries. The Company markets its products using three brand names: IRIS Medical to the ophthalmology market, IRIDERM to the aesthetics market, and Light Solutions to the research and OEM market.

IRIDEX was recognized as one of the fastest growing 100 public companies in Silicon Valley by The Business Journal in their 1999 listing. For further information, visit the Company's website at www.iridex.com.

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934 such as those concerning procedure success rates and adoptions. Actual results could differ materially from those projected in the forward-looking statements. Risks and uncertainties to which the Company is subject may include, but may not necessarily be limited to, continued market acceptance of products, dependence on development of new products and new applications, dependence on collaborative relationships, competitive markets, managing growth, dependence on international sales, and fluctuating quarter to quarter operating results. Other risks and uncertainties include, but are not limited to, risks of manufacturing, dependence on key manufacturers and suppliers, patents and propriety rights, governmental regulation, product liability risks, and volatile stock price. The Company incorporates by reference the risks set forth in the Company's 1999 Form 10-K which was filed on March 31, 2000, and Form 10-Q which was filed on May 16, 2000, and such other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.