FDA approves first nasal spray for dry eye

October 27, 2021 – People with dry eye have a new relief tool after the FDA approved the first nasal spray to treat the condition.

Used twice daily, Tyrvaya brand solution improves signs and symptoms of dry eye.

“We are very excited to bring a new treatment for dry eye disease to patients and ophthalmologists,” said Marian Macsai, MD, chief medical officer of the drug’s manufacturer, Oyster Point Pharma.

The company plans to make the drug available to wholesalers in November. Each bottle offers 15 days of treatment.

The drug will cost $ 10 or less for uninsured patients. Oyster Point negotiates discounts with insurance companies.

The drug, known as varenicline, can be prescribed to anyone with dry eye who has not obtained relief from artificial tears or who needs to use artificial tears “more than three or four times a day. “she said.

“In our pivotal trials, we recruited patients with mild, moderate and severe disease,” Macsai said. “So with this new route of administration and a new mechanism of action, I hope it will bring relief to many dry eye patients who are currently suffering. “

Dry eye can be difficult to treat because its causes are difficult to pinpoint. Varenicline appears to work by stimulating a nerve in the skull causing natural tears to form.

Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cravings. Given as a nasal spray for dry eye, much less ends up in the bloodstream, according to Michael Raizman, MD, associate professor of ophthalmology at Tufts University School of Medicine in Boston, who participated in the studies on the medication.

The spray works in as little as 14 days, rather than the 3 to 6 months required for existing prescription drugs, and it doesn’t irritate the eyes, he says.

“This approval is exciting for the ophthalmic community as it gives us a novel therapeutic agent that can be used alone or in combination with existing therapies to treat people who fall under the umbrella term ‘dry eye’,” said Anat Galor, MD, spokesperson for the American Academy of Ophthalmology and Associate Professor at the University of Miami.

Patricia J. Callender