Zero Residual™ silicone oil-free syringe, tailored for intravitreal injections, receives CE under the new requirements of EU MDR

Authors / Contributors:
SJJ Solutions
Release date:

THE HAGUE, The Netherlands, December 1, 2022 – SJJ Solutions B.V. presents the world’s first CE-approved, silicone oil-free, syringe that is specifically tailored for intravitreal injections. The Zero Residual™ silicone oil-free syringe provides excellent accuracy and handling properties, in line with the ophthalmologists’ needs and does not contain any residual volume after injection. Drug stability in connection with pharmaceutical compounding has been tested¹. Notably, silicone oil deposition in the eye is a known side effect of many syringes currently used for intravitreal injections, but the novel syringe eliminates this risk.¹

“Today’s announcement is an important step in closing the so-called quality gap associated with administration of intravitreal medicines. The syringe reflects SJJ Solutions’ continued commitment to improve both the health-personnel and patient experience with the intravitreal injection procedure, and at the same time reducing medicine spillage and improving efficiency throughout the chain of treatment,” says Jasper Schootstra, CEO at SJJ Solutions.

The Zero Residual™ silicone oil-free syringe has been developed in collaboration with scientists and clinicians at Oslo University Hospital and University of Oslo, Norway. In 2019, SJJ Solutions signed an industry development agreement with Inven2, one of Norway´s largest technology transfer office, on behalf of these two institutions.

The Zero Residual™ silicone oil-free syringe is developed to treat patients with chronic eye conditions, such as neovascular age-related macular degeneration (nAMD). nAMD is a prevalent disease that leads to severe loss of visual acuity if left untreated. Fortunately, nAMD can be treated with  anti-VEGF-inhibitors, protein based drugs that are injected directly into the eye. Typically, 4-12 injections per year are necessary to achieve disease remission.

About SJJ Solutions

SJJ Solutions, founded in 2018, is a Dutch company focused on innovation and development of medical devices. The company has a special interest in providing high quality products for small volume injections. The new syringe is part of the Zero Residual™ concept, a concept that is developed to offer easy and air-free prefilling and storage, a silicone oil-free trail from vial to eye, and excellent properties when used at point of care. SJJ Solutions is partner of (compounding) pharmacies and collaborates with pharmaceutical companies to provide dedicated and customized solutions and support (early) clinical trials.

Contact

General inquiries: info@sjjsolutions.com

Website: www.sjjsolutions.com

References

  1. Gjølberg Torleif T., et al. A Silicone Oil-Free Syringe Tailored for Intravitreal Injection of Biologics. Front. Ophthalmol., 04 May 2022. https://doi.org/10.3389/fopht.2022.882013