Nordic Pharma’s Lacrifill Canalicular Gel Receives CE Mark Approval in the EU

Nordic Pharma, a subsidiary of Nordic Group B.V., has announced that its innovative canalicular gel, Lacrifill, has received CE Mark approval in the European Union, several months ahead of schedule.

A New Option for Dry Eye Disease Management

Lacrifill is a cross-linked hyaluronic acid gel developed to treat dry eye disease (DED) by temporarily occluding the canalicular system, thereby blocking tear drainage. This mechanism helps retain the eye’s natural tears, providing sustained hydration and enhanced ocular comfort.

Administered via a single, in-office procedure, Lacrifill fills the canalicular system and delivers therapeutic effects that can last up to six months.

Personalized Dry Eye Treatment

Nordic Pharma emphasized that Lacrifill offers an individualized approach to dry eye management, an important factor given the prevalence of DED in Europe, where up to 30% of the population is affected. The company also highlighted that managing dry eye disease can become significantly more complex when combined with other ocular pathologies or following procedures like cataract or LASIK surgery.

Preparing for Commercial Launch in Europe

With headquarters in France and the Netherlands, Nordic Pharma is preparing for the commercial rollout of Lacrifill in select European markets. Specific details regarding product availability and distribution will be shared as the launch date approaches.

Leadership Perspective

In a company statement, Charlotte Phelps, CEO of Nordic Group B.V., remarked:

“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.”

U.S. Approval and Supporting Clinical Data

Lacrifill previously received FDA approval in the United States in June 2024, following results from a proof-of-concept pilot study involving 63 patients with dry eye disease. Key outcomes from the study included:

       • 83% of participants reported no pain during or after the procedure

       • 94% experienced no infections

       • 63% reported symptom improvement

These findings support Lacrifill’s potential as a safe and effective treatment option for dry eye sufferers.