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Originally published In Press as doi:10.1167/iovs.08-2969 on December 30, 2008
 (Investigative Ophthalmology and Visual Science. 2009;50:2312-2318.)
© 2009 by The Association for Research in Vision and Ophthalmology, Inc.
doi:10.1167/iovs.08-2969
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Poly-{epsilon}-Caprolactone Intravitreous Devices: An In Vivo Study

Armando Silva-Cunha,1,2 Silvia Ligorio Fialho,2,3 Marie-Christine Naud,2 and Francine Behar-Cohen2,4,5

1From the Faculty of Pharmacy of the Federal University of Minas Gerais, Belo Horizonte, Brazil; 2Physiopathology of Ocular Diseases, Therapeutic Innovations, Centre de Recherche des Cordeliers, René Descartes University, INSERM (Unite of Scientific Medical Research, Institut National de la Santé et de la Recherche Médicale) Research Unit (UMRS) 872, Paris France; 3Pharmaceutical and Biotechnological Development, Fundação Ezequiel Dias, Belo Horizonte, Brazil; 4Department of Ophthalmology, Hôtel-Dieu of Paris University Hospital, René Descartes University, Paris, France; and 5Laboratoire d'Innovations Thérapeutiques, Rothschild Ophthalmologic Foundation, Paris, France.

PURPOSE. The objective of this study was to evaluate the long-term safety and pharmacokinetic profile of a dexamethasone-loaded poly-{epsilon}-caprolactone (PCL) intravitreous implant.

METHODS. The PCL devices were prepared by compression and were inserted into the vitreous of pigmented rabbits. At different time points, vitreous samples were retrieved, and dexamethasone concentration was analyzed by high-performance liquid chromatography. The biodegradation of the implants was evaluated by scanning electron microscopy, and the dexamethasone remaining was evaluated at the end of follow-up. Clinical and histologic examinations were performed to evaluate the implant’s tolerance.

RESULTS. The PCL implant allows for a controlled and prolonged delivery of dexamethasone in rabbits eyes since it released the drug within the therapeutic range for at least 55 weeks. At 55 weeks approximately 79% of the drug was still present in the implant. Biodegradation study showed that PCL implants degradation is very slow. Clinical and histologic observations showed that the devices were very well tolerated in the rabbit eye.

CONCLUSIONS. This study demonstrates the feasibility and tolerance of intravitreous PCL drug delivery systems, which can offer a wide range of applications for intraocular drug delivery because of their controlled and prolonged release over months or even years.






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