Evaluating Replaceable Hydrogel Punctum Plugs as Placebo Vehicles for Sustained Drug Delivery

Noecker, Robert

Evaluating Replaceable Hydrogel Punctum Plugs as Placebo Vehicles for Sustained Drug Delivery

Monday, April 28, 2014: 1:06 PM

Room 155 (Boston Convention and Exhibition Center)

Robert J. Noecker, MD, MBA, Ophthalmic Consultants of Connecticut, Fairfield, CT, USA

Thomas R. Walters, MD, Texan Eye, Austin, TX, USA

Thomas R. Elmer Jr, MD, Fichte Endl & Elmer Eyecare, Amherst, New York, USA

Michael J. Endl, MD, Fichte-Endl Eye Associates, Niagara Falls, New York, USA

Claus M. Fichte, MD, fichte endl & elmer eyecare pc, Niagara Falls, New York, USA

William J. Flynn, MD, University of Texas Health Science Center San Antonio, San Antonio, TX, USA

Narrative Responses:

Purpose
To assess chronic replacement and patient visualization of hydrogel punctum plugs intended for sustained drug delivery over a 1 year period with plug replacements occurring every 3 months.

Methods
Hydrogel punctum plugs containing fluorescein as a visual aid were evaluated in 60 healthy volunteers in a prospective study. Plugs were inserted bilaterally, one in each eye, in either the inferior or superior canaliculus based on physician discretion. Replacement was completed and assessed every 90 days after insertion and patients monitored device presence over a 3-month period. Visualization was performed via slit lamp by the investigator, and using a blue light with yellow filtered mirror by the patients.

Results
Plugs were easily visualized by patients and investigators. Chronic replacement was successful and rated as easy or very easy in 98.3% of the cases. There were no serious or unexpected adverse events in relation to repeated plug replacement.

Conclusion
The hydrogel punctum plug platform is safe and viable as a vehicle for sustained drug delivery. The fluorescein in the punctum plugs aids visualization allowing physicians’ and patients’ ability to monitor its presence. This may be advantageous in overcoming patient non-compliance to topical therapy for chronic conditions such as glaucoma.