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A User-Preference Study on an Ophthalmic Injection Device to Facilitate Microliter Dosing for Intravitreal

Reza Abedian¹, Juergen Pfrang², Simon Buerdel³

¹Medical & Patient Affairs, Sensile Medical AG, Gerresheimer Olten; and reza.abedian@gerresheimer.com.

PDA Journal of Pharmaceutical Science and Technology

|May 14, 2025

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Developing an automated intravitreal injection (IVI) device addresses current challenges. This innovative device offers enhanced patient safety, efficiency, and documentation compared to manual IVI procedures.

Area of Science:

Ophthalmology
Medical Device Development
Biomedical Engineering

Background:

Intravitreal injections (IVIs) are a common treatment for various eye conditions.
Current manual IVI procedures present challenges for patients and healthcare professionals regarding safety, efficiency, and documentation.

Purpose of the Study:

To understand current intravitreal injection practices and identify unmet needs.
To develop and evaluate a novel combination device concept for intravitreal injections.

Main Methods:

Systematic user preference study including online surveys with EU retinologists and interviews with Key Opinion Leaders (KOLs).
Feasibility studies focusing on handling characteristics and injection volume accuracy.
Laboratory testing and user experience evaluation of prototype device concepts for fixed-dose (0.05 ml) injections.

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Main Results:

An automated device concept was identified as a potential solution to address unmet user needs.
Qualitative and statistical analyses indicated significant differences between device-assisted and standard care injections.
The automated device demonstrated potential for increased patient safety, reduced procedure times, and integrated data storage.

Conclusions:

An automated intravitreal injection device offers significant advantages over manual procedures.
The developed device concept has the potential to improve safety, efficiency, and cost-effectiveness in ophthalmic treatments.
Further development and validation are warranted to optimize the device for clinical application.