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25 Jun 2018

French ANSM approves Aptar's Ophthalmic Squeeze Dispenser

Aptar Pharma’s innovative, preservative-free multidose Ophthalmic Squeeze Dispenser. Courtesy of Aptar Pharma.

Approval expands the regulatory acceptance of Aptar Pharma’s OSD as an approved delivery system for preservative-free eye care formulations.

Aptar Pharma’s innovative, preservative-free multidose Ophthalmic Squeeze Dispenser (OSD) 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 OSD.

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 OSD as an approved delivery system for preservative-free eye care formulations.

Addressing the needs of patients and industry

When developing novel eye care products, pharmaceutical companies need to deliver improved patient safety, accurate dosing and product integrity. Aptar Pharma’s OSD meets these key industry and patient needs.

Meeting regulatory requirements worldwide

Aptar Pharma has been working closely with Bausch+Lomb 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+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 OSD is also the first and only FDA-reviewed delivery system for multidose, preservative-free eye care products.

Global acceptance

With more than 150 commercial references worldwide, Aptar Pharma’s OSD 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 OSD 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 pharmaceutical customers worldwide to enter into discussions with regulatory agencies such as the French ANSM with confidence.”

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Aptar Pharma
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