CONTROLLED DRUG-RELEASE IMPLANT FOR 5-FU ADJUVANT THERAPY IN GLAUCOMASURGERY - EXPERIMENTAL-STUDY

Background 5-Fluorouracil (5-FU) is useful as an adjunct treatment for glaucoma filtering surgery. However efficacy depends upon maintaining sustained drugs levels, currently achieved by repeated daily injectio ns of the drug for several days. To overcome this limitation, we desig ned a biodegradable implant for the sustained release of 5-FU. Materia l and methods The implant (0.79 mm diameter; 6mm long, 2.2 mg weight) contains 0.66 mg of 5-FU and is loaded in a needle coupled to a custom -made instrument to permit subconjonctival insertion of the implant th rough a 2 mm wide snip incision. The in vitro and in vivo pharmacokine tics as well as the biocompatibility studies of the implants were asse ssed in the rabbit. Results No infection, inflammatory, reaction or ex trusion occurred. The implant released the drug at a constant rate of 1.20 mu g/hr for over 18 days and totally biodegraded in less than 86 days. Conclusion Implantation of the device, after laser sclerostomy o r conventional trabeculectomy shows great potential for the treatment of glaucoma. To determine the implant's efficacy, additional studies i n the cat are underway.