Oraya Therapeutics, Inc. has released the results of its INTREPID clinical trial evaluating the safety and effectiveness of Oraya Therapy Stereotactic Radiotherapy for the treatment of wet age-related macular degeneration (AMD). The results indicate that a single dose of Oraya Therapy significantly reduces the need for Lucentis injections in persons with wet AMD, with positive safety results one year post-administration.
The study results, entitled Stereotactic Radiotherapy for Neovascular Age-Related Macular Degeneration: 52-Week Safety and Efficacy Results of the INTREPID Study, have been published online ahead-of-print in Ophthalmology, the official journal of the American Academy of Ophthalmology. Ophthalmology publishes original, peer-reviewed research in ophthalmology, including new diagnostic and surgical techniques, the latest drug findings, and results of clinical trials.
The authors are Timothy L. Jackson, Usha Chakravarthy, Peter K. Kaiser, Jason S. Slakter, Ernest Jan, Francesco Bandello, Denis O’Shaughnessy, Michael E. Gertner, Linda Danielson, and Darius M. Moshfeghi, who represent the following international institutions: King’s College London, UK; Queen’s University of Belfast, Northern Ireland; Cole Eye Institute, Cleveland, Ohio; the Digital Angiography Reading Center, Great Neck, New York; Central Military Hospital Prague, Czech Republic; University Vita-Salute, Milan, Italy; Oraya Therapeutics, Inc.; Stanford University, California; and The International Drug Development Institute, Louvain, Belgium.
About Oraya’s Stereotactic Radiotherapy
The term stereotactic describes a surgical technique for directing the tip of a needle or a beam of radiation, via medical imaging, to reach a precise location in the body. In this case, the location is the retina – specifically the macula.
Here is more information from the Oraya Therapeutics website:
Oraya Therapy [also called the IRay System] works with a stereotactic, low-voltage X-ray irradiation system designed specifically for the treatment of [wet] AMD in an outpatient setting.
The IRay System is designed to deliver three overlapping X-ray beams to the macula, each 4 mm in diameter. The beams are directed into the eye while the patient sits comfortably in a chair, with the head positioned on a chin rest. The entire procedure takes about 20 minutes and the patient can go home after the appropriate post-treatment evaluations are made.
About Age-Related Macular Degeneration (AMD)
In wet macular degeneration, the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal vessels that develop into a cluster under the macula (called choroidal neovascularization).
The macula is the part of the retina that provides the clearest central vision. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.
Lucentis and Anti-Angiogenic Drugs
Angiogenesis is a term used to describe the growth of new blood vessels and plays a crucial role in the normal development of body organs and tissue. Sometimes, however, excessive and abnormal blood vessel development can occur in diseases such as cancer (tumor growth) and AMD (retinal and macular bleeding).
Substances that stop the growth of these excessive blood vessels are called anti-angiogenic (anti=against; angio=vessel; genic=development), and anti-neovascular (anti=against; neo=new; vascular=blood vessels).
The focus of current anti-angiogenic drug treatments for wet AMD is to reduce the level of a particular protein (vascular endothelial growth factor, or VEGF) that stimulates abnormal blood vessel growth in the retina and macula; thus, these drugs, including Lucentis, Avastin, and Eylea, are classified as anti-VEGF treatments. At present, these drugs are administered by injection directly into the eye after the surface has been numbed.
At present, these anti-VEGF drugs require monthly injections or a pro re nata [meaning “as needed”] (PRN) regimen, with monthly controls and injections for recurrent or persistent macular bleeding.
The purpose of Oraya’s ongoing INTREPID clinical trial is to evaluate the effectiveness and safety of the Oraya IRay System as compared with as-needed anti-VEGF injections, including its potential to significantly reduce the number of injections (and costs) required to treat wet AMD.
More about the Research
From The Wall Street Journal:
The INTREPID study was the first trial to evaluate the effectiveness and safety of the Oraya Therapy in conjunction with as-needed anti-VEGF injections. A total of 21 sites in five European countries participated in the trial with a total enrollment of 230 patients.
Results of the INTREPID study showed that patients who had previously been treated with anti-VEGF for up to three years experienced a 32 percent reduction of injections and substantially drier retinas with Oraya Therapy compared with the control [i.e., non-treated] group, and 25 percent of Oraya Therapy patients needed no further injections.
Please note: In the United States, Oraya’s IRay Radiotherapy System is an investigational device and is not yet available for sale. Oraya Therapy is available to patients in the United Kingdom at the Optegra Surrey Eye Hospital in Guildford. It will be available in Basel, Switzerland, beginning in May 2013 at the Vista Eye Klinik.
You can read additional and in-depth information about the Oraya IRay treatment at Irv Arons’ Journal in INTREPID Two-year Results Meet Primary Clinical Endpoint. VisionAware will continue to provide updates for this ongoing macular degeneration research as they become available.