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Spotlight on LACRIFILL®

Ophthalmology 360

This Spotlight Series article is editorially independent content.

Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by tear film instability and discomfort. It is primarily caused by lacrimal gland dysfunction, reduced tear production, or excessive evaporation. Symptoms include foreign body sensation, burning, irritation, pain, and light sensitivity. Approximately 16.4 million people in the United States have DED, with rates increasing with age; the condition is more common in women. Despite available treatments, including artificial tears, anti-inflammatory drugs, and punctal occlusion, many patients experience persistent symptoms and unsatisfactory outcomes.1-3

LACRIFILL® Canalicular Gel: A Novel Therapy for DED

LACRIFILL® Canalicular Gel (Nordic Pharma Inc) is an intracanalicular occlusion device that received 510(k) clearance from US Food and Drug Administration (FDA). It is a cross-linked hyaluronic acid derivative administered during an in-office procedure that temporarily blocks tear drainage by occluding the canalicular system. LACRIFILL is indicated for up to 6 months of use in individuals with DED. The gel fills the canalicular lumen, preventing tear outflow through the lacrimal drainage system. It does not require custom sizing and can be removed through canalicular irrigation.4,5

Efficacy Data

FDA clearance was based on a pivotal study of 157 patients. In this prospective, multicenter, randomized, controlled, double-masked study, patients were randomized to receive LACRIFILL or an OASIS Form Fit plug. Eligible patients had at least moderate dry eye, a Schirmer score ≤10 mm, and an Ocular Surface Disease Index (OSDI) score ≥23. The primary endpoint was improvement in Schirmer score at 3 months.4,5

LACRIFILL demonstrated clinically and statistically significant improvements in DED signs and symptoms, including Schirmer score and OSDI, sustained through 6 months. At 3 months, mean change from baseline was 3.9±7.6 mm (P<0.0001) for LACRFILL and 1.9±5.0 mm (P=0.0047) for OASIS. At 6 months, mean change from baseline was 3.8±6.7 mm (P<0.0001) versus 1.8±4.0 mm (P=0.0009), respectively. Changes in anesthetized Schirmer test scores at post-baseline visits are shown in FIGURE 1.4,5

The proportion of patients achieving clinically meaningful improvement in OSDI was 84.3% with LACRIFILL and 83.3% with OASIS. Corneal staining decreased through 6 months with LACRIFILL, while OASIS increased staining at 6 months (see FIGURE 2).4

In a single-site, open-label, prospective, proof-of-concept pilot study, LACRIFILL increased tear retention and volume in 63 patients for at least 3 months. Patients also completed a telephone questionnaire about how their eyes felt at 6 months after LACRIFILL insertion. Most patients reported no pain or infections and overall improvement in symptoms (see FIGURE 3).2

Safety and Tolerability

LACRIFILL was well tolerated, and adverse events (AEs) observed in the pivotal study were consistent with those associated with DED. The most common AEs in the LACRIFILL and OASIS groups were corneal staining (36.9% vs 40.7%), ocular pain (9.7% vs 0%), conjunctivitis (4.9% vs 1.9%), allergic blepharoconjunctivitis (1.0% vs 0%), and epiphora (7.8% vs 5.6%). Two patients (1 in each group) experienced AEs leading to premature discontinuation. No patients experienced treatment-emergent AEs leading to withdrawal.5

The safety and effectiveness of the device beyond 6 months have not been established. Therefore, LACRIFILL should not be used for more than 6 months. After 6 months, it should be removed by thorough lacrimal irrigation.5

Administration

LACRIFILL is supplied in a prefilled injector containing enough gel to treat the upper and lower canaliculi in both eyes. A cannula tip is placed in the punctum, and the gel is inserted. The gel flows through the punctum into the lacrimal sac. If the gel is seen extruding from the upper punctum, both the upper and lower puncta have been blocked.5

For more information, visit https://LACRIFILL.com.

References

  1. Yang N, Mu J, Xu F, et al. Advances in dry eye disease: from immunopathological mechanisms to emerging ophthalmic drug delivery systems. Front Med (Lausanne). 2026;13:1780733. doi:10.3389/fmed.2026.1780733
  2. Fezza JP. Cross-linked hyaluronic acid gel occlusive device for the treatment of dry eye syndrome. Clin Ophthalmol. 2018;12:2277-2283. doi:10.2147/OPTH.S187963
  3. Farrand KF, Fridman M, Stillman IÖ, Schaumberg DA. Prevalence of diagnosed dry eye disease in the United States among adults aged 18 years and older. Am J Ophthalmol. 2017;182:90-98. doi:10.1016/j.ajo.2017.06.033
  4. Packer M, Lindstrom R, Thompson V, et al. Effectiveness and safety of a novel crosslinked hyaluronate canalicular gel occlusive device for dry eye. J Cataract Refract Surg. 2024;50(10):1051-1057. doi:10.1097/j.jcrs.0000000000001505
  5. LACRIFILL Canalicular Gel. Instructions for use. Nordic Pharma Inc.

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