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ReviewPharmaceutics · 2026

Punctal and Intracanalicular Drug Delivery Systems for Ophthalmic Use: A Narrative Review of Technologies, Clinical Outcomes, and Critical Quality Attributes.

Elena O Bakhrushina, Kseniia S Leonova, Nikita O Belyavsky … Vasily D Yartsev

OphthalmologyReview

Drug-free punctal plugs are often expelled early from the tear duct opening.

Punctal and Intracanalicular Drug Delivery Systems for Ophthalmic Use: A Narrative Review of Technologies, Clinical Outcomes, and Critical Quality Attributes.

Elena O Bakhrushina … Vasily D Yartsev

Pharmaceutics · 2026

Background

Conventional ophthalmic eye drops have low bioavailability (<5%) and poor patient adherence, driving the development of sustained-release ophthalmic drug delivery systems.

Purpose

To summarize and critically appraise punctal and intracanalicular drug delivery systems, occlusive devices, and in situ-forming hydrogels with respect to composition, release mechanisms, clinical efficacy, safety, and critical quality attributes (critical quality attributes).

Methods

A narrative literature review was conducted using PubMed, Scopus, Web of Science, Google Scholar, ClinicalTrials.gov, and patent/regulatory sources, including FDA materials and Google Patents, covering 2001-2026.

57.4%

Results

57.4%

over half of drug-free plugs fell out too soon from the eye's tear duct

More results

Drug delivery systems provide release from 7 days (PEGDA hydrogels) to 3 months (Eximore, Ocular Therapeutix™).

In situ systems eliminate size-fitting requirements but face challenges related to gelation control and biodegradation.

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Conclusion · 1 of 2

We propose the following candidate critical quality attributes: retention (>80% over 4 weeks), swelling degree (30-60%), controlled burst release (<40% within 24 h), and mechanical compatibility.

Conclusion · 2 of 2

The proposed QTPP matrices for punctal, intracanalicular, and in situ systems may guide the development of ophthalmic drug delivery platforms.

Post

Punctal and Intracanalicular Drug Delivery Systems for Ophthalmic Use: A Narrative Review of Technologies, Clinical Outcomes, and Critical Quality Attributes.

Drug-free punctal plugs are often expelled early from the tear duct opening.

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