|
=====================================
THE MAGNIFIER - Electronic Edition
Issue #3, March 2, 2000
Produced by: Macular Degeneration Foundation
P.O. Box 9752, San Jose, CA 95157
http://www.eyesight.org
=====================================
The following is a press release issued today, Thursday, March 2, 2000 by IRIDEX. We will
follow up with an overview of the study in the near future.
=====================================
IRIDEX Announces Major Macular Degeneration Study
MOUNTAIN VIEW, Calif.--March 2, 2000--IRIDEX
Corporation NASDAQ/NMS:IRIX) announced that enrollment has commenced in a Company sponsored twenty center clinical trial which could validate an effective therapy for the majority of patients with wet age-related macular
degeneration (AMD), the leading cause of blindness in the western world.
The study titled "Transpupillary Thermotherapy (TTT) Of Occult Subfoveal Choroidal Neovascular Membranes (CNV) In Patients With Age-Related
Macular Degeneration" (shortened to TTT4CNV) is a prospective, randomized, sham-controlled, multicenter clinical trial intended to ultimately determine the effectiveness of TTT in the treatment of occult CNV caused by
AMD when compared to no treatment.
The study protocol uses a low dose of infrared laser light, without adjunctive therapeutic drugs, for the treatment of eyes with occult wet AMD. The laser used for the study is
the Company's commercially available IRIS Medical OcuLight(r) SLx infrared laser photocoagulator. A retrospective pilot study performed by Elias Reichel, M.D., Assistant Professor of Ophthalmology at the New England Eye Center,
Tufts University School of Medicine, reported successful reduction in fluid caused by AMD in 94% of treated eyes and stabilization or improvement in vision in 75% of treated eyes. The TTT4CNV study design was based on the protocol
developed by Dr. Reichel during the pilot study.
Dr. Reichel will serve as the Study Chairman and will also perform as the Principal Investigator of the Study Center at the New England Eye Center in Boston. Dr. Reichel
commented, "Hopefully, this study will prove the efficacy of TTT for the treatment of occult CNV, the most common form of wet macular degeneration."
AMD is a progressive disease that damages the central
vision and affects a person's ability to read, see faces, and drive. About 50 million people worldwide have AMD and, of these, about 5 million have the more severe wet form. The wet form can manifest in two types: classic or
occult. Over 70% of patients with wet AMD have the occult type. This is the group of patients targeted by the TTT4CNV clinical trial.
To be eligible for the TTT4CNV Trial, the patient must be 50 years or older, have at
least one eye (the study eye) with subfoveal occult CNV and visual acuity between 20/50 and 20/400. Completion of patient enrollment is expected to take several months at 20 participating centers across the U.S. When study centers
begin enrolling patients, they will be added to the list of enrolling centers posted on the IRIDEX website. Patient follow-up is expected to take a minimum of one year.
http://www.irismedical.com/TTT4CNVctrs.htm
Coordination of the TTT4CNV Trial will be performed at the New England Eye Center, Tufts University School of Medicine. Independent reading of patient photographs will be performed at The Fundus Photograph Reading Center at the
University of Wisconsin-Madison, under the direction of Matthew D. Davis, M.D. Data coordination and biostatistical analysis will be performed by Arbor Biostatistical Consultants, Ann Arbor, MI, under the direction of Davi C.
Musch, Ph.D., M.P.H. Donald J. D'Amico, M.D., of the Massachusetts Eye & Ear Infirmary, Harvard Medical School, Mark W. Johnson, M.D., of the W.K. Kellogg Eye Center, University of Michigan, and Thomas R. Friberg, M.D., of The
Eye & Ear Institute, University of Pittsburgh, will serve on the Data, Safety and Monitoring Committee.
"This is a landmark study," commented Theodore A. Boutacoff, President & CEO of IRIDEX.
"The TTT4CNV Clinical Trial is designed to and will hopefully provide rigorous clinical validation of TTT treatment for occult wet AMD. I believe that the trial outcome will confirm and support the encouraging data from the
growing number of non-randomized pilot studies which have been reported. In essence, the TTT4CNV trial will address patients with occult subfoveal CNV, a condition with no proven therapy. The great majority of patients with wet AMD
do not appear to be treatable with photodynamic therapy (PDT)."
TTT for the treatment of occult wet AMD is only one of five approaches IRIDEX has developed to treat AMD. Two of these approaches are directed at
treating the more common dry form of AMD, while three approaches are directed at treating the more severe wet form. Therefore, unlike most companies who are developing a single approach to treat a specific stage of AMD, IRIDEX is
developing a number of applications to treat AMD at various stages of the disease.
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 predominantly through a direct sales force and internationally through 65 independent distributors into 74countries. The
Company markets its products using three brand names: IRIS Medical to the ophthalmology market, IRIDERM to the dermatology market, and Light Solutions to the research 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 http://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. Actual results could differ materially from those projected in the forward-looking statements. Forward looking
statements involve risks and uncertainties to which the Company is subject, including but not necessarily limited to, continued market acceptance of products, dependence on development of new products and new applications,
dependence on collaborative relationships, and competitive markets. The Company incorporates by reference the risks set forth in the Company's 1998 Form 10-K which was filed on April 1, 1999, and Form 10-Q which was filed on
November 15, 1999, 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.
=============================
The
MAGNIFIER is distributed without charge. We hope that it will continue to serve the interests of its subscribers. Contributions to Macular Degeneration Foundation are appreciated and may be sent to P.O. Box 9752,
San Jose, CA 95157
=============================
Disclaimer: The above information does not constitute medical advice. Only your physician or licensed ophthalmologist can dispense medical advice based upon a
complete and thorough evaluation of your specific and unique situation.
|
|
