"New generation minimally invasive bleb-forming surgery"
Meet the team
PEYEONEER MedTech is a spin-off from a Chemelot InSciTe project. An international multidisciplinary collaboration between Maastricht University, Maastricht UMC+, Eindhoven University of Technology, and InnFocus inc., a Santen company.
Advisory board / Consultants
Glaucoma
Glaucoma is a degenerative eye condition that stands as the leading cause of irreversible blindness on a global scale. Despite treatment efforts, approximately 10% of patients ultimately suffer complete vision loss. Elevated intraocular pressure represents the primary risk factor for glaucoma, and reducing this pressure remains the only proven approach to impede disease progression. Initial treatment typically involves eye drops or laser therapy, with surgical intervention (glaucoma surgery) becoming necessary if these measures prove ineffective in adequately lowering intraocular pressure.
The gold standard
For several decades, trabeculectomy has served as the gold standard surgical procedure within glaucoma management. This technique involves creating a surgical fistula covered with the patient's own tissue, enabling excess intraocular pressure to escape into a surgically formed bleb. However, trabeculectomy is burdened by an intense postoperative course and frequently fails due to fibrosis and scarring. Consequently, glaucoma drainage implants have been developed to overcome these limitations. These implants consist of a polymeric tube, typically made of silicone, implanted within the anterior chamber of the eye, along with a polymeric endplate composed of silicone or polypropylene. The tube facilitates the drainage of excessive intraocular pressure, while the endplates prevent the fusion of ocular tissue layers.
Despite being an effective procedure, over 50% of these implantations fail within a five-year period. This failure can be attributed to excessive fluid drainage resulting in hypotony (abnormally low eye pressure) or an immune response directed towards the implant, leading to fibrosis and scarring. Thus, despite existing treatment options, a considerable number of glaucoma patients continue to experience blindness, highlighting the limitations and high failure rate associated with current surgical interventions.
Novel implant
To solve the problems with glaucoma filtration surgery, we have developed a novel miniature glaucoma drainage implant. Our implant is approximately 80% smaller than current implants and is made from an inert and biocompatible polymer called SIBS. This unique material has been shown to provoke minimal to no immune response. We have conducted an animal study comparing our miniature implant to a commercially available implant (Ahmed Glaucoma Valve). The results indicate that our implant is equally effective in draining fluid from the eye, while also promoting improved wound healing compared to silicone-based implants.
By introducing our innovative glaucoma drainage implant, we aim to provide a solution that addresses the limitations and failure rates associated with existing implants. Our product aims to improve patient outcomes by reducing the risk of complications, such as hypotony and immune responses (fibrosis and scarring), and offering more reliable and efficient fluid drainage.
Subsidy Projects
OPZuid: SIGHT project
Scientific and Innovative Glaucoma Healthcare Technologies project:
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Project partners:
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PEYEONEER MedTech BV
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Medace BV
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Maastricht University
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University Eye Clinic Maastricht UMC+
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Project duration:
Start January 1st, 2024
end December 31st, 2026
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Summary:
The SIGHT project aims to further develop and prepare for the market introduction of a novel miniature glaucoma implant, called the Glaucoma RING. The project is divided into six work packages (WPs) with specific objectives:
1. Project Management: Ensures a streamlined execution and administration of the entire project to guarantee successful goal realization.
2. Promotion and Publicity Activities: Focuses on promoting the SIGHT project and communicating about the work carried out, results, and knowledge exchange at national and international levels.
3. Development into a Clinical Production Process: Develops a fully validated production process for the glaucoma implant that meets European and American medical standards (ISO13485) to enable commercial-scale production.
4. Conducting Preclinical Validation Study: Carries out an extensive preclinical evaluation of the glaucoma implant in animal models to assess safety, efficacy, and potential side effects.
5. Development into a Fully Digital Documentation and Quality System: Focuses on digitizing the documentation and quality system for more efficient management and regulatory compliance.
6. Clinical Validation: Aims to obtain ethical documentation for the first clinical study in humans.
The project strives for the development of an integrated glaucoma implant ready for surgical placement in patients. The intended outcomes per work package are precisely described, ranging from a validated production process to obtaining ethical approval for clinical studies. The implementation of the SIGHT project takes place within the Brightlands ecosystem in South Limburg. It contributes to the health transition by utilizing innovative technologies, promoting collaboration, and positioning Southern Netherlands as a hub for health innovation.
On social, ecological, and economic levels, the project promises a holistic impact, with sustainable development at its core. The innovative design with a unique biocompatible polymer contributes to technological advancement, while skills development is encouraged, and collaboration is promoted. The project also offers economic potential through improved treatment outcomes and lower operational costs.