Development of a novel valved drug-eluting glaucoma implant for safe and durable reduction of intraocular pressure

For the reduction of intraocular pressure, implants are well accepted in therapy of refractory glaucoma. Encapsulation and the resulting long term failure are the major limitations of todays’ commercially available devices. This paper describes methods for the development and characterization of a novel drug-eluting microstent for glaucoma therapy. Microstents were coated with a polymer-drug compound of poly(4-hydroxybutyrate)/paclitaxel 85/15 % (w/w) and analyzed in vitro with regard to coating mass, morphology and release kinetic. Achieved coating mass was 485.7 ± 16.4 μg (n = 18). Release of therapeutic potent doses paclitaxel (5.8E ± 2.5E mol L, n = 4) within 1 month was proven. The presented technology is suitable for the reproducible manufacturing of drug-eluting microstents. Inhibition of fibrosis in vivo will be investigated in future trials.