Juan-Carlos Gutiérrez-Hernández1, Sean Caffey2, Walid Abdallah3, Phillip Calvillo2, Roberto González2, Jason Shih2, Jeff Brennan2, Jenna Zimmerman2, Juan-Carlos Martínez-Camarillo1, Anthony R Rodriguez4, Rohit Varma5, Arturo Santos6, Gisela Sánchez6, Mark Humayun7. 1. Doheny Eye Institute, Los Angeles, CA ; Centro de Retina Médica y Quirúrgica, SC, Zapopan, Jalisco, Mexico. 2. Replenish Inc., Pasadena, CA. 3. 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. 4. Doheny Eye Institute, Los Angeles, CA. 5. Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA. 6. Centro de Retina Médica y Quirurgica, SC and Tecnológico de Monterrey, Campus Guadalajara, Mexico. 7. Replenish Inc., Pasadena, CA ; Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Abstract
PURPOSE: 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. CONCLUSION: This study shows that the Replenish Posterior MicroPump could be successfully implanted with good safety profile in this animal model. TRANSLATIONAL RELEVANCE: 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.
PURPOSE: 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. CONCLUSION: This study shows that the Replenish Posterior MicroPump could be successfully implanted with good safety profile in this animal model. TRANSLATIONAL RELEVANCE: 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.
Entities:
Keywords:
biocompatibility; intravitreal drug delivery; micropump
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