CGBio said on the 17th that its polydeoxyribonucleotide (PDRN)-based skin booster, “DCLASSY PDRN,” has received approval for an investigational device exemption (IDE) from the Ministry of Food and Drug Safety (MFDS) in Asia, and will begin full-scale clinical trials to secure an indication for improving wrinkles around the eyes.
The clinical trial is scheduled to begin at the end of May and will involve a total of 366 adult men and women aged 19 to 65. The study will systematically evaluate the safety and efficacy of DCLASSY PDRN following injections administered to wrinkles around both eyes.
DCLASSY PDRN is a next-generation PDRN skin booster developed by CGBio. It focuses on addressing patient burden factors identified in existing PDRN products, such as pain during injection, post-procedure embossing effects and concerns over nodules.
In particular, it is designed based on high-purity, low-viscosity PDRN, allowing for smoother injection and even distribution within the skin, while reducing the burden of returning to daily activities immediately after the procedure.
The company said it expects high levels of patient satisfaction not only for delicate areas such as around the eyes, where the skin is thin and sensitive, but also among patients requiring repeated procedures.
Following the launch of its CaHA-based collagen booster “DCLASSY CaHA” last year, CGBio is strengthening its multi-skin booster lineup by adding this PDRN product, enabling selection based on skin condition and treatment purpose. Through this, the company aims to enhance its competitiveness as a provider of customized solutions in the aesthetics market.
CEO Yoo Hyun-seung said, “Through this clinical trial, we plan to demonstrate safety and efficacy and actively pursue entry into both domestic and global markets, targeting a launch in 2027,” adding, “We will establish differentiated product competitiveness in the aesthetics market centered on DCLASSY CaHA and DCLASSY PDRN and set a new standard.”