Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes

(Reuters) -Oyster Point Pharma Inc's treatment for dry eye disease became the first U.S. approved nasal spray for the chronic condition on Monday, sending the drug developer's shares about 19% higher premarket.

The company said its spray, Tyrvaya, will be made available from next month to patients with a prescription, but did not reveal its pricing.

The condition — characterized by stinging, sensitivity to light, blurred vision and eye fatigue — affects about 38 million Americans, and is currently treated with over-the-counter artificial tear drops such as GenTeal and Refresh.

Prescription eye drops, such as Novartis' Xiidra, AbbVie Inc's Restasis and Sun Pharmaceutical's Cequa are also used to treat dry eye disease.

Oyster Point said Tyrvaya, a twice daily nasal spray, was tested in a late-stage and two mid-stage trials covering over 1,000 patients with mild, moderate or severe symptoms of dry eye disease (DED).

Data from the trials showed that Tyrvaya demonstrated statistically significant improvement in production of tear film on eye surface in all trials, the company said in March.

Tear film helps to keep eyes moist, reducing risks of infection and contributing to clear vision.

Tyrvaya, the first U.S. Food and Drug Administration approved product for Oyster Point, works by activating a nerve that stimulates natural tear film production, and in turn relieving symptoms of dry eye disease.

"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.

(Reporting by Leroy Leo and Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)