- Trial to evaluate the safety and tolerability of the R:GENTM laser in patients with early-stage Age-Related Macular Degeneration -
BILLERICA, Mass., March 9, 2021 /PRNewswire/ - Lutronic Vision ("Lutronic" or the "Company"), a wholly-owned subsidiary of Lutronic Corporation, today announced that it has treated the first early-stage Age-Related Macular Degeneration ("AMD") patient in its clinical trial evaluating the R:GENTM laser.
"Following a COVID-19 pandemic-related delay, we are pleased to initiate this study to evaluate the potential of R:GENTM as a treatment for AMD, with the goal of establishing R:GENTM as a best- and first-in-class treatment for this debilitating disease in its early stages, where there is high unmet need," said Jhung Won Vojir, PhD, President and COO of Lutronic Vision. "We intend to use data from previous trials, this current trial and from future clinical evaluations to support the potential approval of R:GENTM by the U.S. Food and Drug Administration."
Mark Humayun, MD, PhD, an ophthalmologist, engineer, scientist, inventor and recipient of the National Medal of Technology and Innovation from U.S. President Barack Obama, commented, "As AMD is a leading cause of blindness that results in permanent loss of central vision, R:GENTM has the potential to address a significant unmet need by slowing or preventing disease progression."
The single-arm, open-label pilot study will enroll approximately 30 early-stage AMD patients who will be treated with R:GENTM and evaluated at 24 and 48 weeks. The primary and secondary objectives are to assess the safety and tolerability of R:GENTM in subjects with early stages of AMD; and to evaluate the progression and severity of AMD after treatment with R:GEN at 24 and 48 weeks post-treatment, respectively. Lutronic expects to complete the trial by the end of 2022, with results available in 2023.
The trial will be conducted at the Centre for Eye Research Australia in Melbourne, Australia. Professor Robyn Guymer, a world-renowned AMD expert and key opinion leader, is the study's principal investigator. A clinician scientist, Dr. Guymer has served as principal investigator for many industry sponsored trials in AMD and has contributed to the approval of leading therapeutics for retinal disease including the neovascular (wet) form of advanced AMD. "I am excited to working with Lutronic in this great venture to assess if R:GENTM can slow the progression to vision loss in this very common and devastating disease," stated Dr. Guymer.
R:GEN™ uses Selective Retina Therapy to target retinal pigment epithelium (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:GENTM transfers energy to the established retinal treatment area to potentially improve the function of adjacent RPE cells. R:GENTM uses proprietary Real Time Feedback Technology (RTF) to optimize laser energy for maximum therapeutic benefit while minimizing thermal damage.
R:GEN™ has received Korea's Ministry of Food and Drug Safety approval for Central Serous Chorioretinopathy ("CSC") and Diabetic Macular Edema ("DME"); U.S. Food and Drug Administration clearance for clinically significant macular edema; and CE Mark for the treatment of CSC, DME and the dry form of AMD.
AMD is an age-related ocular condition that affects individuals aged 50 years and older. AMD is the third leading cause of blindness worldwide and the 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 15 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-stage. 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 Retina 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 retinal lasers that will ultimately lead to better vision and an 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.
SOURCE Lutronic Vision, Inc.