FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
Drug developer Oyster Point Pharma Inc said on Monday the U.S. Food and Drug Administration had approved its nasal spray treatment for dry eye disease.
The company said the spray, Tyrvaya, will be available from next month to patients with a prescription.
The regulator’s decision was based on safety and efficacy results from a late-stage and two mid-stage trials covering over 1,000 patients with mild, moderate or severe symptoms of dry eye disease (DED).
More than 30 million people in the United States are affected by the chronic condition characterized by stinging, sensitivity to light, blurred vision and eye fatigue.
Oyster Point in March said data from the trials showed that Tyrvaya demonstrated statistically significant improvement in production of tear film on eye surface in all trials.
Tear film helps to keep eyes moist, reducing risks of infection and contributing to clear vision.
“A product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient,” Ed Holland, director of cornea services at Cincinnati Eye Institute and professor of ophthalmology at University of Cincinnati said in the company’s statement.
Tyrvaya is a nasal spray formulation of the drug varenicline, also used in Pfizer Inc’s smoking cessation drug, Chantix.
Tyrvaya works by activating a nerve that stimulates natural tear film production, and in turn relieving symptoms of dry eye disease.