[THE INVESTOR] Lutronic
announced on Oct. 6 that its laser device R:GEN has been approved by the US Food and Drug Administration to treat macular edema, that causes thickening and swelling of the yellow central area of the retina.
It is the first laser therapy to treat the eye disease, and the first time a South Korean ophthalmic medical instrument has been approved in the US, according to the manufacturer.
R:GEN can selectively treat retinal pigment epithelium, or the pigmented cell layer of retina, which is 5-micrometer thick and inaccessible with existing laser therapies.
Boosted by the approval, Lutronic will expand its clinical trials on diabetic macular edema and central serous chorioretinopathy, or a collection of fluid under the retina that results in visual distortion, to the US, from South Korea and Europe.
By Hwang You-mee (firstname.lastname@example.org