Hydrogel punctal plugs safe, viable means for sustained drug delivery

Take-Home

Hydrogel punctal plugs may be a safe and viable method for delivery of anti-glaucoma drugs in the future.

Dr. Noecker

By Lynda Charters; Reviewed by Robert J. Noecker, MD

Norwalk, CT-Hydrogel punctal plugs (Ocular Therapeutix) loaded with fluorescein for visualization were evaluated in subjects for 1 year. The devices were found to be easy or very easy to insert, indicating that the plugs may be a safe and viable method of drug delivery of anti-glaucoma drugs in the future.

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The hydrogel platform is comprised of drug-eluting punctal plugs. The tailored drug release is compatible with a wide range of pharmaceuticals, such as travoprost, dexamethasone, and moxifloxacin, among others. The device is placed noninvasively in the intracanalicular space through the punctum.

“The comfort and retention of the device have been demonstrated for up to 3 months,” said Robert J. Noecker, MD, in private practice, Norwalk, CT.

NEXT:Presence of the plugs

Presence of the plugs

Dr. Noecker and colleagues conducted a multicenter study at three sites in the United States to assess chronic replacement and subject visualization of the hydrogel punctal plugs that are intended for future sustained drug delivery over a 1-year period. Sixty healthy volunteers were enrolled in the study.

The plugs were inserted unilaterally or bilaterally (one in each eye) based on patient eligibility. The plugs were placed into the inferior or superior punctum and were replaced at roughly 90, 180, and 300 days after insertion of the original plug.

The study patients were asked to monitor the continued presence of the plugs using a blue light and yellow filter mirror. The plugs were loaded with fluorescein for ease of visualization. The plugs did not have to be removed because they are absorbed over time, according to Dr. Noecker.

The interim study results indicated that replacement was successful in 93% of patients. Almost all subjects (98.3%) described the replacement of the plugs as easy or very easy. In all cases, the subjects’ confirmation of the presence of the plugs agreed with the matched investigators assessment of the presence of the plugs. The investigators were able to visualize the punctal plugs easily under the slit lamp with the blue light and yellow filter mirror, Dr. Noecker noted.

NEXT: Conclusion

The investigators concluded that the hydrogel punctal plug platform may be a safe and viable means for achieving sustained drug delivery.

“Numerous studies have demonstrated this, including non-drug plug studies and various drug-eluting plug studies,” he said. “Fluorescein conjugated with polyethylene glycol in the punctal plugs gives physicians and patients the ability to monitor the presence of the plugs for durations of therapy.

“Hydrogel punctal plugs may be a useful alternative to topical drop therapy to circumvent patient non-compliance in chronic conditions, such as glaucoma,” he added. 

Robert J. Noecker, MD

E: noeckerrj@gmail.com

This device is investigational and not yet available commercially in the United States. The study was sponsored by Ocular Therapeutix. Dr. Noecker is a paid consultant, received research support, and has a financial interest in the company.