Abstract
Abstract Primary open angle glaucoma represents an eye disease that usually is associated with an increased intraocular pressure (IOP). Implants for micro-invasive glaucoma surgery (MIGS) are gaining importance as a promising option for IOP lowering. Currently available devices are implanted into the eye ab interno based on a clear corneal incision and drain aqueous humour into the schlemm’s canal, suprachoroidal or subconjunctival space. Fibrosis is known as a major limitation for long term success and often leads to the necessity of an additional medication or a surgical re-intervention. The current work focusses on the development of an antifibrotic drug-eluting coating for a minimally invasive implantable glaucoma microstent. Tubular microstent base bodies manufactured from a polycarbonate based silicone elastomer were spray-coated with a chloroform based mixture of the same polymer and the antifibrotic drug pirfenidone (PFD, P2116, Merck KGaA, Germany) in a polymer/drug ratio of 85/15% (w/w). Coating mass of 89 μg according to a drug loading of 1.96 μg mm-2 was aspired. Coating mass was measured using an ultramicrobalance (XP6U, Mettler-Toledo International, Inc., Switzerland). Glaucoma microstent prototypes with a drugeluting coating mass of (84 ± 19) μg (n = 12) were manufactured. Characterization by means of scanning electron microscopy (Quattro S, Thermo Fisher Scientific, FEI Deutschland GmbH, Germany) yielded a reproducible smooth surface of the coating. High performance liquid chromatography (KNAUER Wissenschaftliche Geräte GmbH, Germany) was used for analysis of drug release behaviour in 0.9% NaCl solution at 37°C. The in vitro PFDrelease is characterized by an initial burst phase of approximately 6 h followed by a more retarded release phase. The entire drug was released within 36 h (n = 3). Sterilization processing has a minor impact on drug release kinetics. Appropriate drug stability after sterilization could be proven. Future studies will focus on the antifibrotic properties of drug-eluting glaucoma microstents in animal studies.
Highlights
Glaucoma represents a major cause for vision impairment and blindness worldwide [1]
Primary open angle glaucoma as the most prevalent type of the eye disease is usually associated with an increased intraocular pressure (IOP) [2]
Implants for micro-invasive glaucoma surgery (MIGS) are gaining importance as a promising treatment option with a decreased risk for serious complications compared to conventional glaucoma drainage devices (GDD) or surgical approaches for IOP-lowering, trabeculectomy
Summary
Glaucoma represents a major cause for vision impairment and blindness worldwide [1]. Primary open angle glaucoma as the most prevalent type of the eye disease is usually associated with an increased intraocular pressure (IOP) [2].Implants for micro-invasive glaucoma surgery (MIGS) are gaining importance as a promising treatment option with a decreased risk for serious complications compared to conventional glaucoma drainage devices (GDD) or surgical approaches for IOP-lowering, trabeculectomy. Glaucoma represents a major cause for vision impairment and blindness worldwide [1]. Primary open angle glaucoma as the most prevalent type of the eye disease is usually associated with an increased intraocular pressure (IOP) [2]. Implants for micro-invasive glaucoma surgery (MIGS) are gaining importance as a promising treatment option with a decreased risk for serious complications compared to conventional glaucoma drainage devices (GDD) or surgical approaches for IOP-lowering, trabeculectomy. Available devices for MIGS are implanted into the eye ab interno based on a clear corneal incision and drain aqueous humour into the schlemm’s canal, suprachoroidal or subconjunctival space [3]. The aqueous humour drained from the anterior chamber of the eye and the incorporated growth factors, the transforming growth factor-β (TGF-β), contribute to the proliferation of fibroblasts. Wound healing after the implantation of a conventional GDD and after the
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