title: One-Year Feasibility Study of Replenish MicroPump for Intravitreal Drug Delivery: A Pilot Study.
abstract: OBJECTIVE
  To determine the feasibility of the surgical procedure and to collect some safety data regarding the bioelectronics of a novel micro drug pump for intravitreal drug delivery in a Beagle dog model for up to 1 year.
  
  
  METHODS
  Thirteen Beagle dogs were assigned to two groups. The experimental group (n= 11) underwent pars plana implantation of MicroPump; the body of which was sutured episclerally, while its catheter was secured at a pars plana sclerotomy. The control group (n= 2) underwent sham surgeries in the form of a temporary suturing of the MicroPump, including placement of the pars plana tube. Baseline and follow-up exams included ophthalmic examination and imaging. The experimental animals were euthanized and explanted at predetermined time points after surgery (1, 3, and 12 months), while the control animals were euthanized at 3 months. All operated eyes were submitted for histopathology.
  
  
  RESULTS
  Eyes were scored according to a modified McDonald-Shadduck system and ophthalmic imaging. Neither the implanted eyes nor the control eyes showed clinically significant pathological changes beyond the expected surgical changes. The operated eyes showed neither significant inflammatory reaction nor tissue ingrowth through the sclerotomy site compared with the fellow eyes.
  
  
  CONCLUSIONS
  This study shows that the Replenish Posterior MicroPump could be successfully implanted with good safety profile in this animal model.
  
  
  CONCLUSIONS
  The results of this study in a Beagle dog model are supportive of the biocompatibility of Replenish MicroPump and pave the way to the use of these devices for ocular automated drug delivery after further testing in larger animal models.
authors.affiliation: Doheny Eye Institute, Los Angeles, CA ; Centro de Retina Médica y Quirúrgica, SC, Zapopan, Jalisco, Mexico.
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Gutiérrez-Hernández
authors.affiliation: Replenish Inc., Pasadena, CA.
authors.forename: Sean
authors.initials: S
authors.lastname: Caffey
authors.affiliation: Replenish Inc., Pasadena, CA ; Department of Ophthalmology, Zagazig University, Faculty of Medicine, Zagazig, Egypt ; Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Walid
authors.initials: W
authors.lastname: Abdallah
authors.affiliation: Replenish Inc., Pasadena, CA.
authors.forename: Phillip
authors.initials: P
authors.lastname: Calvillo
authors.affiliation: Replenish Inc., Pasadena, CA.
authors.forename: Roberto
authors.initials: R
authors.lastname: González
authors.affiliation: Replenish Inc., Pasadena, CA.
authors.forename: Jason
authors.initials: J
authors.lastname: Shih
authors.affiliation: Replenish Inc., Pasadena, CA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Brennan
authors.affiliation: Replenish Inc., Pasadena, CA.
authors.forename: Jenna
authors.initials: J
authors.lastname: Zimmerman
authors.affiliation: Doheny Eye Institute, Los Angeles, CA ; Centro de Retina Médica y Quirúrgica, SC, Zapopan, Jalisco, Mexico.
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Martínez-Camarillo
authors.affiliation: Doheny Eye Institute, Los Angeles, CA.
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Rodriguez
authors.affiliation: Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Rohit
authors.initials: R
authors.lastname: Varma
authors.affiliation: Centro de Retina Médica y Quirurgica, SC and Tecnológico de Monterrey, Campus Guadalajara, Mexico.
authors.forename: Arturo
authors.initials: A
authors.lastname: Santos
authors.affiliation: Centro de Retina Médica y Quirurgica, SC and Tecnológico de Monterrey, Campus Guadalajara, Mexico.
authors.forename: Gisela
authors.initials: G
authors.lastname: Sánchez
authors.affiliation: Replenish Inc., Pasadena, CA ; Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
authors.forename: Mark
authors.initials: M
authors.lastname: Humayun
keywords: biocompatibility; intravitreal drug delivery; micropump