Aptar Pharma’s multidose dispenser approved by ANSM

Aptar Pharma’s innovative, preservative-free multidose ophthalmic squeeze dispenser is the approved delivery device for Bausch+Lomb’s Levofree Multidose in France. This marks the first approval by the French National Agency for Medicines and Health Products Safety (ANSM) for Aptar Pharma’s Ophthalmic Squeeze Dispenser.

Levofree is a prescription product for the treatment of allergic conjunctivitis. ANSM approved the multidose dispenser and drug combination in May 2018. This approval further expands the regulatory acceptance of Aptar Pharma’s Ophthalmic Squeeze Dispenser as an approved delivery system for preservative-free eye care formulations.

Aptar Pharma has been working closely with Bausch+Lomb, one of the world’s leading Eye Care companies, to achieve this first ANSM approval of an Eye Care product in its multidose device.

The ANSM approval culminates a long and robust process. Prior to approval, Bausch and Lomb provided comprehensive, detailed microbiological study results which showed that microorganisms can neither survive nor form colonies in or on the container. In addition, user studies were performed that confirmed the user-friendliness of the multidose device within the patient target group.

The ophthalmic squeeze dispenser is also the first and only FDA-reviewed delivery system for multidose, preservative-free eye care products.

With more than 150 commercial references worldwide, Aptar Pharma’s ophthalmic squeeze dispenser continues to meet the evolving needs of consumers, patients and the industry. The ergonomic intuitiveness of the squeezable container with a low actuation force contributes to the high levels of acceptance.

Aptar Pharma’s ophthalmic squeeze dispenser system is the result of more than 10 years of development and experience in the delivery of preservative-free ophthalmic solutions.

"Our Ophthalmic Dispenser technology has been a great success for our customers," explained Matthias Birkhoff, Vice President Business Development, Aptar Pharma. "The proven and unrivalled microbiological safety, combined with a precise and reproducible drop ejection, allows pharma customers worldwide to enter into discussions with regulatory agencies such as the French ANSM with confidence."