Nordic Pharma Announces CE Mark Approval for Lacrifill® Canalicular Gel, Paving the Way for European Launch
Hoofddorp, Netherlands – 07 April 2025 – Nordic Group B.V., an international pharmaceutical company operating as Nordic Pharma, announced today that Lacrifill®, a novel therapy for dry eye, has just received CE mark approval. This significant regulatory milestone achieved several months ahead of schedule, allows Nordic Pharma to introduce Lacrifill® across European markets, with a planned launch in the coming months.
Lacrifill® is a cross-linked hyaluronic acid gel designed to temporarily block tear drainage by occluding the canalicular system. By enhancing tear film preservation, Lacrifill® helps keep the eyes bathed in their own natural tears, offering an individualized approach to dry eye management. The in-office procedure provides a full fill of the canalicular system and delivers long-lasting effects for up to six months. Dry eye disease is a very prevalent condition affecting up to 30% of European population. Management of dry eye is particularly challenging in the context of certain ocular surgeries such as cataract and LASIK surgery.
Following the launch of Lacrifill® in the United States last year, Nordic Pharma now plans to expand its footprint in Europe, bringing this innovative dry eye solution to a broader patient population.
“Receiving CE mark approval for Lacrifill® is an important milestone for Nordic Pharma and adds to our commitment to innovative ophthalmic therapies in Europe,” said Charlotte Phelps, CEO of Nordic Group B.V. “We are excited to bring this novel dry eye solution to patients and healthcare professionals across Europe and look forward to the upcoming launch.”
With its regulatory approval secured, Nordic Pharma is now preparing for the commercial rollout of Lacrifill® in key European markets. Further details regarding availability and distribution will be shared closer to the launch date.