The Tear Film and Ocular Surface Society’s (TFOS) Dry Eye Workshop (DEWS) III report has included a major clinical win for Nordic Pharma, Inc., a subsidiary of Nordic Group B.V.: the inclusion of LACRIFILL Canalicular Gel, indicated for the treatment of dry eye symptoms.
A major win indeed … but let’s start with this report.
TFOS’s DEWS III report is the latest installment of the nonprofit organization’s original DEWS report.
Some background on this: That first report was published in the Ocular Surface Journal in 2007 as a global consensus on DED resulting from a +3-year, global collaborative effort of 150 clinical and research experts.
- Its intent: Reviewing current knowledge of DED as well as methods used for diagnosing, evaluating, and treating the ocular surface disease (OSD) via evidence-based, unbiased reference material.
And to follow that up: The DEWS II report was published in 2017 with an intent to redefine dry eye as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film.
So that brings us to this latest report?
Yup. TFOS began its rollout of DEWS III at the end of May with the release of individual sections.
First up (as we reported in early June): the Diagnostic Methodology report.
- See here for that coverage and those details.
Among the changes to note: Updates to the definition of “dry eye”—check it out.
Now to LACRIFILL.
LACRIFILL Canalicular Gel is a patented dry eye therapy derived from cross-linked hyaluronic acid (HA) and indicated to temporarily block tear drainage by the occlusion of the canalicular system.
- How it works: The device is administered via an in-office procedure to enable patients’ eyes to “be bathed in their own natural tears,” is customizable for each patient, and supplies a “full fill” of the canalicular system.
Its regulatory status: The device was granted FDA 501(k) clearance in January 2022 under the ownership of Visant Medical, Inc.—and launched to the U.S. market in June 2024 under Nordic, following its 2023 acquisition.
Duly noted. Now to this DEWS III inclusion.
Two clinical studies within the report examine LACRIFILL, specifically in Section 6.2.4 New Plug Designs and Other Technologies, for its dry eye treatment.
- The first study: A single-site, prospective, open-label study evaluating the use of LACRIFILL in 63 DED participants for whom tear supplements weren’t effective.
- Those results: Improvements (relative to baseline)were observed for the following parameters 3 months after LACRIFILL fitting:
- Corneal staining
- Schirmer test scores
- Tear breakup time (TBUT)
- Tear meniscus height (TMH)
- Those results: Improvements (relative to baseline)were observed for the following parameters 3 months after LACRIFILL fitting:
And the second study?
A prospective, multicenter, double-masked randomized controlled trial (RCT) was conducted with 157 dry eye patients to compare the use of LACRIFILL (n = 99) to another commercially available hydrogel canalicular plug (n = 52), inserted bilaterally.
The results: LACRIFILL was found to be “non-inferior to plugs for the mean Schirmer test score change from baseline” as well as for the number of participants who achieved a clinically important improvement in Ocular Surface Disease Index (OSDI).
- Notably: DED signs and symptoms’ “clinically and statistically significant improvements” continued through 6 months.
What were investigators’ conclusions?
LACRFILL was deemed to be a safe, well-tolerated, and effective therapy for treating DED (via canalicular occlusion).
- Check out the full section here (scroll to page 38)—and take note: This study is referenced as supporting clinical trial and product data on LACRIFILL’s product website.
Nice! Any other data on this therapy to be aware of ?
Indeed. New research was also recently presented during the 2025 Women in Ophthalmology (WIO) Summer Symposium held over the weekend.
Those case studies include:
- A Case of LACRIFILL Canalicular Gel Treatment in a Patient Following Refractive Cataract Surgery
- Presented by Jennifer Loh, MD (see here for details)
- A Case of LACRIFILL Canalicular Gel Treatment in a Patient With Demodex Blepharitis Infestation and Uncontrollable DED
Presented by Selina McGee, OD, FAAO (see here for details)