title: Implantable MicroPump for Drug Delivery in Patients with Diabetic Macular Edema.
abstract: OBJECTIVE
  To demonstrate the safety and surgical feasibility of the first-in-man ocular implant of a novel Posterior MicroPump Drug Delivery System (PMP) in patients with diabetic macular edema (DME) and to report on the device capabilities for delivering a programmable microdose.
  
  
  METHODS
  This was a single center, single arm, open-label, prospective study. Eleven patients with DME and visual acuity equal to or worse than 20/40 were included. The PMP prefilled with ranibizumab was implanted into the subconjunctival space. After implantation, the PMP was wirelessly controlled to deliver a programmed microdose. Comprehensive ophthalmic exams and optical coherence tomography were performed biweekly for 90 days. At the end of the study, the PMP was explanted and the subjects thereafter received standard of care for DME (i.e., laser or intravitreal injections).
  
  
  RESULTS
  All 11 surgical implantations were without complications and within the skill sets of a retinal surgeon. No serious adverse events occurred during the follow-up period. At no point were visual acuity and central foveal thickness worse than baseline in the implanted eye. The PMP delivered the programmed ranibizumab dosage in seven subjects. The remaining four patients received a lower than target dose, and the treatment was complemented with standard intravitreal injection.
  
  
  CONCLUSIONS
  This study demonstrates the first-in-man safety of the Replenish MicroPump implant for a period of 90 days and its capability to deliver a microdose into the vitreous cavity. Further studies to enable longer-term safety and to demonstrate the feasibility of multiple programmable drug delivery are necessary.
authors: Department of Ophthalmology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
authors: Mark
authors: M
authors: Humayun
authors: Medical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
authors: Arturo
authors: A
authors: Santos
authors: Medical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
authors: Juan Carlos
authors: JC
authors: Altamirano
authors: Replenish, Inc., Pasadena, CA, USA ; Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil.
authors: Ramiro
authors: R
authors: Ribeiro
authors: Medical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
authors: Roberto
authors: R
authors: Gonzalez
authors: Medical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
authors: Alejandro
authors: A
authors: de la Rosa
authors: Replenish, Inc., Pasadena, CA, USA.
authors: Jason
authors: J
authors: Shih
authors: Replenish, Inc., Pasadena, CA, USA.
authors: Changling
authors: C
authors: Pang
authors: Replenish, Inc., Pasadena, CA, USA.
authors: Fukang
authors: F
authors: Jiang
authors: Replenish, Inc., Pasadena, CA, USA.
authors: Philip
authors: P
authors: Calvillo
authors: Altaviz, LLC, Lake Forest, CA, USA.
authors: John
authors: J
authors: Huculak
authors: Replenish, Inc., Pasadena, CA, USA.
authors: Jenna
authors: J
authors: Zimmerman
authors: Replenish, Inc., Pasadena, CA, USA.
authors: Sean
authors: S
authors: Caffey
keywords: age-related macular degeneration; diabetic macular edema; drug delivery; macular degeneration; ocular drug delivery
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