AptarGroup, Inc., a global leader in drug delivery, consumer product dispensing and active material science solutions, today announced that its patented Cartridge Pump System (CPS), designed for the multidose delivery of preserved and non-preserved drug formulations, was recently reviewed by the U.S. FDA as the drug delivery device in the approval of Oyster Point Pharma’s TYRVAYA (varenicline solution) Nasal Spray 0.03 mg, the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease.

TYRVAYA, a highly selective cholinergic agonist, is the first nasally-administered pharmaceutical therapy to treat the signs and symptoms of dry eye disease to have been approved by the U.S. FDA.

This approval makes Aptar’s Cartridge Pump System a key component of the first and only U.S. FDA-approved pharmaceutical therapy to deliver treatment for the signs and symptoms of dry eye disease, an ophthalmic condition, via the nasal route and re-confirms Aptar’s expertise for developing innovative drug delivery solutions.

Stephan B. Tanda, Aptar’s President and CEO stated:

“This approval further demonstrates the broad potential for Aptar’s drug delivery solutions and the continued market opportunities for nasal drug delivery. We are pleased that our proven CPS nasal system is now a multidose delivery option for patients suffering from dry eye disease.”

About Dry Eye Disease

Dry eye disease is a multifactorial chronic disease of the ocular surface characterized by a loss of homeostasis of the tear film, resulting in a multitude of symptoms. More than 340 million adults globally and approximately 38 million adults in the United States are estimated to suffer from dry eye disease.

Solution for Nasally Administered Treatments

Aptar Pharma’s innovative, multidose Cartridge Pump System (CPS) is the result of over 15 years of development and experience in the delivery of preserved and unpreserved nasal formulations. Specifically designed to enable reliable, exact dosing and targeted medication delivery to the nasal mucosa, the versatile CPS Technology Platform is used for nasal drug delivery across a wide range of medical applications such as allergic rhinitis, pain, CNS as well as intra‑nasal vaccination.

Accelerated Drug Development Support via Aptar Pharma Services

The effort to bring TYRVAYA Nasal Spray to market included a Combination Product submission by Oyster Point Pharma to the FDA, which benefited from Aptar Pharma’s Services offering – a comprehensive portfolio of stage-specific development packages. Aptar Pharma’s dedicated Regulatory Affairs professionals and analytical scientists help customers proactively address regulatory needs to accelerate approval.

Gael Touya, President, Aptar Pharma said:

“We are pleased that Aptar Pharma’s CPS Technology has been successfully reviewed by the U.S. FDA for Oyster Point Pharma’s therapy for the treatment of the signs and symptoms of dry eye disease via the nose. This project once again underlines Aptar Pharma’s ability to develop and deliver complex drug delivery systems, and demonstrates our expertise in partnering with customers through their successful drug development journeys.”