Zeiss Medical Technology Receives NMPA Approval for ILM-Blue in China

Zeiss Medical Technology has announced that ILM-Blue, an internal limiting membrane (ILM) dye developed by Dutch Ophthalmic Research Center (DORC), has received approval from China’s National Medical Products Administration (NMPA). The regulatory milestone marks the first availability of a DORC posterior segment dye product in the Chinese market.

A Globally Trusted Solution for Vitreoretinal Surgery

ILM-Blue, marketed in the United States as Tissue Blue, has been available in Europe since 2010 and remains the only ILM dye approved by the U.S. FDA. The product is designed to enhance visualization of the ILM during vitreoretinal (VR) surgery, clearly distinguishing it from underlying retinal layers and thereby reducing the risk of retinal trauma.

To date, ILM-Blue has been used in over 900,000 surgical procedures worldwide, reinforcing its reputation as a clinically proven, high-performance dye solution in retinal surgery.

Expanding Access to Innovative Retina Solutions in China

“We are delighted to bring ILM-Blue to the Chinese market, where it will provide retina surgeons with a proven, high-quality staining solution to enhance visualisation,” said Jessie Jiang Bo, General Manager of DORC in China.
“This approval reinforces our dedication to expanding access to innovative ophthalmic solutions that help surgeons improve patient outcomes.”

Strategic Integration into the Zeiss Surgical Portfolio

Carl Zeiss Meditec AG completed the acquisition of DORC in April 2024, following the agreement announced in late 2023. As a result, DORC’s Eva Nexus VR surgery platform is now integrated into Zeiss Medical Technology’s surgical offerings.

“ZEISS and DORC are committed to supporting surgeons in the China market with the latest innovation and tools that create a higher standard of care and better patient experience,” said Pierre Billardon, Head of Business Sectors Surgery Posterior Segment at Zeiss Medical Technology and CEO of DORC International.
“The global success of ILM-Blue underscores the company’s commitment to providing high-quality and effective solutions to the ophthalmic community.”

With this approval, Zeiss Medical Technology and DORC further strengthen their position in the Chinese ophthalmic surgery market, supporting retina surgeons with advanced tools for safer and more effective VR procedures.