In July 2018, Korea’s Ministry of Health and Welfare granted R:GEN Conditional new Health Technology Assessment (nHTA) Approval and designated SNUH as a participating medical institution. The Conditional nHTA Approval allows for out-of-pocket medical treatment and collection of clinical data to support final nHTA Approval, which would determine R:GEN’s reimbursement coverage.
“In a significant milestone for Lutronic, we are excited to introduce Korea’s first retina treatment laser through the Ministry’s Conditional nHTA program,” said Jhung Vojir, PhD, President and COO of Lutronic Vision. “The conditional approval is mutually beneficial: patients are able to access treatment for CSC with R:GEN, while Lutronic collects data from treated patients to support the device’s nHTA Approval. We are looking forward to working with SNUH as it treats CSC patients, while we continue to prepare to initiate clinical trials of R:GEN in another ophthalmic indication later this year.”
R:GEN is a laser that targets retinal pigment epithelium (RPE) cells. In CSC, the RPE becomes susceptible to leaks, causing the accumulation of fluid in the subretinal space that can cause visual impairment and retinal detachment. Using proprietary Real Time Feedback Technology, R:GEN transfers energy to the established retinal treatment area to repair the leaks in the RPE, optimizing laser energy for maximum therapeutic benefit while minimizing thermal damage.
R:GEN is Korea’s first retina treatment laser, and has received Korea’s Ministry of Food and Drug Safety approval for CSC and diabetic macular edema (DME); U.S. Food and Drug Administration approval for clinically significant macular edema; and CE Mark for the treatment of CSC, DME and the dry form of Age-related Macular Degeneration (AMD).
In addition to CSC, Lutronic is developing R:GEN for the treatment of early-stage AMD, for which there are currently no approved therapies. The Company plans to initiate clinical trials of R:GEN for the treatment of AMD in Australia by the end of 2019.
Source: Company Press Release.
