Lutronic Vision’s R:GEN retina treatment laser has been used to treat the first patient with central serous chorioretinopathy at Seoul National University Hospital, the company announced in a press release.
R:GEN received conditional new health technology assessment approval from Korea’s Ministry of Health and Welfare in July 2018, which allows for out-of-pocket medical treatment and clinical data collection to support final approval and determine reimbursement coverage, the release said.
“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,” Jhung Vojir, PhD, president and chief operating officer of Lutronic Vision, said in the release.
The R:GEN laser is also approved for diabetic macular edema in Korea and clinically significant macular edema in the United States and has a CE mark for central serous chorioretinopathy, diabetic macular edema and dry age-related macular degeneration in Europe.