Systematic Literature Reviews Comparing the Long-Term Safety Outcomes for the Port Delivery System with Ranibizumab...

Area of Science:

• Ophthalmology
• Medical Devices
• Drug Delivery Systems

Background:

• Ocular implants crossing the sclera are used for treating various eye diseases.
• The Port Delivery System with ranibizumab (PDS) is a newer ocular implant requiring safety evaluation.
• Comparative safety data is crucial for establishing the PDS's role in clinical practice.

Purpose of the Study:

• To compare post-surgical complication types and rates of the PDS with existing scleral-crossing ocular implants.
• To assess the long-term safety profile of the PDS in comparison to established devices.

Main Methods:

• Systematic literature reviews of clinical trials and real-world studies on scleral-crossing ocular implants.
• Analysis of long-term (≥18 months) safety data from identified studies.
• Comparison of complication rates and types for the PDS (from Phase III trials) against data from other implants.

Main Results:

• 16 clinical trials and 43 real-world studies were reviewed, covering 15 implant types and 8 ocular diseases.
• Device-related complications occurred in 0.7% (trials) and 1.3% (real-world) of eyes.
• PDS complication rates in Phase III trials were within the ranges reported for other ocular implants, including cataract, vitreous hemorrhage, and retinal detachment.

Conclusions:

• Post-surgical complication rates for the PDS in Phase III trials align with those of other scleral-crossing ocular implants.
• The long-term safety of the PDS appears consistent with established ocular devices in ophthalmology.
• The PDS demonstrates a safety profile comparable to existing ocular implant technologies.