FDA Approves Aptar Nasal Pump System as First Nasally-Administered Pharmaceutical Treatment for Dry Eye Disease

The FDA has approved a varenicline solution (Tyrvaya, Oyster Point Pharma) nasal spray 0.03 mg1 as the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease, according to a press release.

Dry eye is a chronic disease of the ocular surface characterized by a loss of homeostasis of the tear film, which can result in a multitude of symptoms. The condition impacts more than 340 million adults globally.

Varenicline solution is the first pharmaceutical therapy approved by the FDA to treat the signs and symptoms of dry eye disease. Additionally, the Aptar Cartridge Pump System (CPS) will be the first and only FDA-approved treatment for dry eye disease via the nasal route, according to the press release.

CPS has been in the process of development for more than 15 years and is specifically designed to enable reliable, exact dosing and targeted medication delivery to the nasal mucosa.

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

REFERENCE

First Nasally-Administered Pharmaceutical Treatment for Dry Eye Disease Approved by US FDA with Aptar’s Nasal Pump System. BusinessWire. October 25, 2021. Accessed October 26, 2021. https://www.businesswire.com/news/home/20211025005101/en