ZEISS Medical Technology's ILM-Blue Receives NMPA Approval in China, Expanding Surgical Options for Retinal Surgeons
Key Insights
ILM-Blue (search), a vital staining dye used in vitreoretinal surgery, has received NMPA approval in China, becoming the first DORC (search) posterior dye product available in the Chinese market.
The product, which has been used in over 900,000 procedures worldwide since 2010, helps surgeons clearly distinguish the inner limiting membrane (search) from underlying retinal layers, reducing risk of retinal damage.
This approval marks a significant milestone for ZEISS Medical Technology (search) and DORC (search) International following their April 2024 acquisition, reinforcing their commitment to expanding innovative ophthalmic solutions globally.
ZEISS Medical Technology (search) announced that ILM-Blue (search)®, a specialized staining dye from Dutch Ophthalmic Research Center (search) (DORC (search)), has received approval from China's National Medical Products Administration (search) (NMPA). This regulatory milestone significantly expands access to advanced vitreoretinal surgical tools in one of the world's largest healthcare markets.
ILM-Blue (search)® is designed to clearly stain and distinguish the inner limiting membrane (search) (ILM) from underlying retinal layers during vitreoretinal surgery. This enhanced visualization facilitates precise membrane removal while reducing the risk of retinal damage during delicate ophthalmic procedures.
"We are delighted to bring ILM-Blue (search) to the Chinese market, where it will provide retina surgeons with a proven, high-quality staining solution to enhance visualization," said Jessie Jiang Bo, General Manager of DORC (search) in China. "This approval reinforces our dedication to expanding access to innovative ophthalmic solutions that help surgeons to improve patient outcomes."
Global Impact and Clinical Significance
Since its European launch in 2010, ILM-Blue (search)® has been utilized in more than 900,000 procedures worldwide, establishing itself as a trusted tool for vitreoretinal surgeons. The product remains the only ILM staining solution approved by the U.S. Food and Drug Administration (FDA), where it is marketed under the brand name TissueBlue®. According to a 2023 survey of U.S. retinal surgeons at the American Society of Retina Specialists meeting, it ranks as the #1 preferred ILM stain among specialists in the United States.
Pierre Billardon, Head of Business Sectors Surgery Posterior Segment at ZEISS Medical Technology (search) and CEO of DORC (search) International, emphasized the strategic importance of this approval: "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. The global success of ILM-Blue (search) underscores the company's commitment to providing high-quality and effective solutions to the ophthalmic community."
Clinical Evidence and Applications
The efficacy of ILM-Blue (search)® has been documented in multiple clinical studies. Research has demonstrated its value in various vitreoretinal procedures, including those for myopic traction maculopathy (search). A study by Figueroa et al. examined long-term outcomes of 23-gauge pars plana vitrectomy with ILM peeling and gas tamponade, highlighting the importance of proper visualization during these delicate procedures.
Additional multicenter clinical assessments have confirmed the effectiveness of these "heavy" dyes for retinal membrane staining during macular surgery, providing surgeons with improved visualization capabilities that can lead to better surgical outcomes.
Strategic Business Development
This approval comes at a significant time for both companies. Carl Zeiss Meditec AG completed its acquisition of DORC (search) in April 2024, integrating DORC's Eva Nexus vitreoretinal surgery platform into the existing ZEISS surgical portfolio. The acquisition, announced in late 2023, represents a strategic expansion of ZEISS's ophthalmic surgery capabilities.
DORC (search), headquartered in Zuidland, the Netherlands, has grown over its 40-year history into a successful international business with more than 800 employees. The company exports its products to more than 80 countries worldwide, with ILM-Blue (search)® now becoming its first posterior dye product available in China.
Market Implications
The approval of ILM-Blue (search)® in China represents a significant opportunity for ZEISS and DORC (search) in the rapidly growing Chinese ophthalmic market. As the population ages and the prevalence of retinal disorders increases, the demand for advanced surgical tools and techniques continues to rise.
For Chinese retinal surgeons, access to ILM-Blue (search)® provides a new option for enhancing surgical precision in procedures such as macular hole (search) repair, epiretinal membrane (search) removal, and other vitreoretinal interventions where clear visualization of the ILM is critical for successful outcomes.
Future Outlook
With this regulatory approval, ZEISS and DORC (search) are positioned to further expand their presence in the Chinese ophthalmic market. The companies' combined expertise in surgical visualization, instrumentation, and innovative solutions creates a comprehensive offering for ophthalmic surgeons.
As part of Carl Zeiss Meditec AG, which generated revenue of €2,066.1 million in fiscal year 2023/24 and employs over 5,730 people worldwide, DORC (search) now has enhanced resources to continue developing innovative solutions for ophthalmic surgery while leveraging ZEISS's global distribution network and research capabilities.