Aptar Pharma alleviates dry eye syndrome with FDA-approved Cartridge Pump System
27 Oct 2021 --- US-based Aptar Group has received approval from the US Food and Drug Administration (FDA) for its patented Cartridge Pump System (CPS) as a nasal delivery system for dry eye syndrome.
Oyster Point Pharma, a biopharmaceutical company specializing in ophthalmology, uses CPS for its Tyrvaya Varenicline solution, the only nasal spray approved to treat the signs and symptoms of dry eye disease.
The effort to bring Tyrvaya nasal spray to market includes a combination product submission by Oyster Point Pharma to the FDA, which benefits from Aptar Pharma’s Services offering – a comprehensive portfolio of stage-specific development packages.
CPS development
The CPS results from over 15 years of development and experience in the delivery of preserved and unpreserved nasal formulations, says Aptar.
The innovation comes amid a tide of pharmaceutical packaging developments.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, and intranasal vaccination.
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. According to the company, more than 340 million adults globally and approximately 38 million adults in the US are estimated to suffer from dry eye disease.
“We are pleased the US FDA has successfully reviewed Aptar Pharma’s CPS Technology for Oyster Point Pharma’s therapy for the treatment of the signs and symptoms of dry eye disease via the nose,” says Gael Touya, president of Aptar Pharma.
“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 journey.”
Aptar Pharma’s dedicated Regulatory Affairs professionals and analytical scientists help customers address regulatory needs to accelerate approval, says the company.
Aptar boosts pharma packs
Aptar’s FDA approval for CPS technology comes as the company makes strides in pharmaceutical packaging innovation amid the COVID-19 pandemic.
This year, the company’s Activ-Film technology was used as protective packaging for two at-home COVID-19 tests. The tests received Emergency Use Authorization from the US FDA.
In June, Aptar Food + Beverage partnered with REBO to offer a reusable water bottle using Bluetooth technology to help combat dehydration.
Using a sensor and a laser, the Bluetooth-embedded cap tracks the amount of water the user consumes. “Both systems enable you to measure the amount of water you drink by counting the number of times the bottle is opened and closed and the amount of water that remains in the bottle,” a REBO spokesperson told PackagingInsights.
Edited
By Louis Gore-Langton
