Design and Development of a Suprachoroidal Spacer Implant and Injector System for Glaucoma Treatment.

Glaucoma is a leading cause of visual impairment and blindness worldwide, with level of intraocular pressure (IOP) as the only modifiable risk factor. There is a critical need for a safe, effective, and minimally invasive procedure that can be performed in an outpatient setting without a dedicated operating room. Suprachoroidal expansion has been explored as a method to lower IOP, but existing approaches face challenges with long-term stability and procedural complexity. Here, we developed a monolithic, photo-cross-linked polyethylene glycol (PEG) suprachoroidal spacer implant, designed to remain in place long-term with minimal clearance or degradation, potentially enabling long-term IOP reduction. To facilitate safe and precise delivery, we also designed a custom microneedle injector system. The implant's composition, shape, and mechanics were optimized for suprachoroidal implantation. Ex vivo studies demonstrated precise control over implant location and volume within the suprachoroidal space, achieving an 89.5% successful delivery rate. In a pilot in vivo study using rabbits, the implantation procedure showed no signs of foreign body response, local toxicity, or adverse tissue reactions. Further preclinical studies are needed to evaluate its long-term stability and potential for sustained IOP reduction.