One-Year Feasibility Study of Replenish MicroPump for Intravitreal Drug Delivery: A Pilot Study

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Drug Delivery Systems

Background:

• Intravitreal drug delivery is crucial for treating posterior segment ocular diseases.
• Novel drug delivery systems are needed to improve therapeutic efficacy and patient compliance.
• Micro-scale devices offer potential for sustained and localized drug release.

Purpose of the Study:

• To assess the feasibility of surgically implanting the Replenish Posterior MicroPump for intravitreal drug delivery.
• To collect safety and biocompatibility data of the micro drug pump in a Beagle dog model for up to one year.
• To evaluate the bioelectronic performance and tissue response to the implanted device.

Main Methods:

• Thirteen Beagle dogs were divided into an experimental group (n=11) receiving MicroPump implantation and a control group (n=2) undergoing sham surgery.
• The MicroPump was implanted via pars plana, with the catheter secured at the sclerotomy site.
• Ophthalmic examinations, imaging, and histopathology were performed at 1, 3, and 12 months post-surgery.

Main Results:

• No clinically significant pathological changes were observed in implanted or control eyes beyond expected surgical alterations.
• The operated eyes exhibited minimal inflammatory reactions and no significant tissue ingrowth at the sclerotomy site.
• The Replenish Posterior MicroPump demonstrated a favorable safety profile in the Beagle dog model.

Conclusions:

• The Replenish Posterior MicroPump can be successfully implanted surgically with a good safety profile in this animal model.
• The study supports the biocompatibility of the Replenish MicroPump for ocular automated drug delivery.
• Further testing in larger animal models is warranted to advance the use of these devices.