Fibrosis-Resistant Bleb-Free Gaucoma Implant - DESCRIPTION (provided by applicant): The objective of this Phase I SBIR project is to test the feasibility of using a novel biomaterial design for improved Glaucoma Drainage Device (GDD) performance. The proposed innovation has the eventual aim to enhance our current STARfloTM Glaucoma Implant device by increasing its drainage efficiency with a fibrosis-minimizing surface geometry. This could allow use of a smaller implant and simplify placement surgery. Significance: Glaucomatous eyes usually have impeded drainage systems, causing intraocular pressure (IOP) to build, damaging the optic nerve and leading to blindness. GDDs are increasingly relied on as a surgical approach to reduce IOP. The established GDD paradigm depends on maintaining a permanent subconjunctival filtering bleb, with risks of bleb leaks and infection, and of fibrosis-related bleb-failure. An efficient, low-fibrosis, bleb-independent GDD with low complication rate would have a major impact. Innovation: STARfloTM is a new GDD comprised entirely of Healionics' proprietary STAR® biomaterial, a precision microporous structure of biocompatible silicone geometrically optimized to reduce fibrosis and induce ingrowth of a dense capillary network from the surrounding tissue, obviating formation of a bleb. This drainage mechanism, soft sponge design, and fibrosis- resistant pore geometry give it several advantages over competing GDDs. It has CE Mark approval, and early clinical results are promising. To enable a less-invasive smaller STARflo device, we propose to further improve drainage efficiency by forming the porous structure with a heavily textured surface. We have demonstrated that such a geometry, comprising surface-adhered granules of STAR biomaterial, gives a further remarkable reduction in fibrotic encapsulation. To closely approximate the granular surface in a continuously microporous form suitable for a GDD, we will apply a double templating technique using pyramidal salt crystals. Approach: The target Milestones - to be achieved in a rabbit model - are: 1) histological evidence that texturing reduces fibrosis in the suprachoroidal site, 2) evidence that texturing improves IOP-lowering performance for a given size implant, and 3) demonstration that a smaller and less invasive textured device can deliver equivalent IOP-lowering performance to the current larger STARflo implant. A follow on Phase II would leverage the commercialization and regulatory momentum of the current STARflo device by advancing the new design into a pilot clinical study.
