Lutronic Vision Engages World Renowned Retina Expert for R:GEN™ Pilot AMD Clinical Study
BILLERICA, Mass., March 26, 2019 (GLOBE NEWSWIRE) -- Lutronic Vision (“Lutronic” or “the Company”), a wholly-owned subsidiary of Lutronic Corporation, today announced that it has signed a memorandum of understanding with Professor Robyn Guymer to serve as the principal investigator for Lutronic’s planned pilot clinical study. The study will evaluate the Company’s R:GEN™ laser for the treatment of the earlier stages of age-related macular degeneration (“AMD”).
“Dr. Guymer is a distinguished retinal disease specialist with extensive clinical experience in AMD, so we are honored that she will be leading our planned clinical study where the R:GEN™ laser will be evaluated as a potential treatment for patients who are diagnosed with the earlier stages of AMD,” said Jhung Vojir, PhD, President and COO of Lutronic Vision. “This is a significant milestone for Lutronic, particularly following our strategic shift toward earlier stages of AMD intervention. Our R:GEN™ technology presents a significant opportunity to treat AMD prior to advanced forms of the disease since there are no effective treatment options and therefore earlier intervention represents the potential to address a very large unmet need. We intend to use the results of this trial along with the data from a pivotal clinical study to support a potential approval from the U.S. Food and Drug Administration.”
The pilot clinical study is sponsored by Lutronic and is anticipated to begin in the second half of 2019. Lutronic plans to conduct this study at Dr. Guymer’s clinical research facility in Melbourne, Australia.
Professor Robyn Guymer is a world-renowned AMD expert and key opinion leader with extensive experience in AMD clinical research and patient management. A clinician scientist, she leads a team of 20 researchers who primarily investigate AMD at the Centre for Eye Research Australia. Dr. Guymer has served as principal investigator for many industry sponsored trials and has contributed to the approval of leading therapeutics for retinal disease including the neovascular (wet) form of late AMD.
“I am looking forward to collaborating with Lutronic on the clinical evaluation of the R:GEN™ laser in subjects with the earlier stages of AMD,” said Dr. Guymer. “The vast majority of patients who have AMD have the earlier forms of the disease and various risk factors appear to result in advanced disease over time, which presents either as wet AMD or geographic atrophy (GA), both of which cause permanent decline of central vision. Wet AMD is a result of neovascularization which results in blood and fluid leaking into the retina, leading to a rapid and severe loss of vision if treatment is not commenced. GA on the other hand, results in death of photoreceptors and retinal pigmented epithelium (RPE) cells, leading to slow, progressive and irreversible severe loss of vision. The course of AMD could be improved with earlier intervention, yet there are no effective treatments. Based on this significant unmet need, I am enthusiastic about the potential of Lutronic’s R:GEN™ laser and I am looking forward to working with the Company to evaluate its use in patients with the earlier forms of AMD.”
R:GEN™ is a laser that targets RPE cells. Among their many other functions, RPE cells recycle protein and lipids, however in AMD, the ability of the RPE cells to clear debris is impaired, causing the accumulation of cellular waste material. This waste material forms abnormal deposits, called drusen, which further impair RPE cell function, eventually resulting in vision loss. R:GEN™ transfers energy to the established retinal treatment area to potentially improve the function of adjacent RPE cells. R:GEN™ uses proprietary Real Time Feedback Technology (RTF) to optimize laser energy for maximum therapeutic benefit while minimizing thermal damage.
AMD is an age-related ocular condition which affects people 50 years and older. AMD is the third leading cause of blindness worldwide and the primary leading cause of vision loss in the Western world. It is estimated that close to 288 million people will be affected by AMD by 2040. In the United States, approximately 11 million individuals have some form of AMD, where due to a rise in the aging population, it is estimated that the prevalence will double by 2050. AMD is classified as either early, intermediate or late. There are two forms of late AMD; dry (non-exudative) or wet (exudative) disease. Unfortunately, most of AMD is not treated as there are currently no effective treatments, except for wet AMD.
ABOUT LUTRONIC VISION
Lutronic Vision is bringing to market the world’s first laser for Selective Retina Therapy™ with Real Time Feedback (RTF) Technology. Our system, named R:GEN™, is a fully integrated laser platform that safely and precisely targets the Retinal Pigmented Epithelium to re-generate and re-store its function. Whereas older retinal photocoagulator lasers destroyed retinal tissue in an effort to preserve vision, R:GEN™ aims to revitalize retinal tissue by stimulating repair. Through this pioneering mechanism, we aim to introduce a new concept in ophthalmic lasers that will ultimately lead to better vision and improved quality of life for patients around the world.
ABOUT LUTRONIC CORPORATION
Lutronic Corporation, a leading innovator of Aesthetic, Vision, and Surgical lasers and related technology, was established in 1997 to bring intuitive, robust, versatile devices which are affordable and efficacious to the worldwide medical community. Committed to improving medicine, Lutronic Corporation partners with key opinion leaders to advance science and ensure efficacy of its systems.
With a focus on physician needs and patient outcomes, Lutronic Corporation dedicates time and funding toward the development of devices that offer features and improvements not found in today’s market. Devoting more than 15% of revenue to R&D, Lutronic holds more than 137 current and pending patents. With more than 430 employees worldwide, Lutronic has offices in the US, Korea, China, Japan, and Europe, distributors world-wide, focused R&D centers in both the US and Korea, and is ever expanding.
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