Nordic Pharma receives CE Mark for canalicular gel Lacrifill

(Image Credit: AdobeStock/Denys Rudyi)

In a press release, Nordic Pharma, a subsidiary of Nordic Group B.V., announced that its canalicular gel Lacrifill has received CE Mark approval in the European Union. The approval arrived several months ahead of schedule, Nordic Pharma noted. Lacrifill is a cross-linked hyaluronic acid gel designed for the treatment of dry eye disease. The gel temporarily blocks tear drainage by occluding the canalicular system.¹

According to Nordic Pharma, Lacrifill enhances ocular comfort by preserving the eye’s natural tears, offering an individualized approach to dry eye management. A single, in-office procedure gives the patient a full fill of the canalicular system with effects that may last as long as 6 months. Dry eye disease affects up to 30% of the European population, and there are many recent research findings confirming both its prevalence and its impact on quality of life. As the Nordic Pharma press release detailed, management of dry eye disease can become more challenging when paired with other ocular pathologies or following procedures such as cataract surgery and LASIK surgery.

Nordic Pharma, which is headquartered in France and the Netherlands, is preparing for a commercial rollout of Lacrifill in select European markets. As the company approaches the launch date, details of the commercialization, including product availability, will become available.

Charlotte Phelps, CEO of Nordic Group B.V., commented on the approval in the company’s news release. “Receiving CE mark approval for Lacrifill is an important milestone for Nordic Pharma and adds to our commitment to innovative ophthalmic therapies in Europe. We are excited to bring this novel dry eye solution to patients and healthcare professionals across Europe and look forward to the upcoming launch,” she said.

Lacrifill received approval in the United States in June 2024. That approval followed the release of research findings of a proof-of-concept pilot study of the gel, which involved 63 patients with dry eye disease. The study found that 83% of participants experienced no pain, 94% of participants had no infections, and 63% reported that their eyes felt better after treatment.²

References

1. Nordic Pharma Announces CE Mark Approval for Lacrifill® Canalicular Gel, Paving the Way for European Launch. Press release. Nordic Group B.V.. Published April 7, 2025. Accessed April 7, 2025.

2. Joy J. Lacrifill canalicular gel from Nordic Pharma releases in the US. Optometry TImes. Published June 4, 2024. Accessed April 7, 2025. https://www.optometrytimes.com/view/nordic-group-bv-announces-commercial-launch-of-lacrifill-canalicular-gel