Oyster Point’s Novel Dry-Eye Nasal Spray Snags FDA Approval

Oyster Point Pharma’s dry-eye treatment, Tyrvaya (varenicline), has won FDA approval as the first nasal spray in the U.S. to treat the chronic condition.

The approval was supported by multiple trials — enrolling more than 1,000 patients with mild, moderate or severe dry-eye disease — which demonstrated that the treatment significantly improved tear production at four weeks.

New Jersey-based Oyster Point said it plans to launch the prescription drug next month, making it available in cartons containing two multidose spray bottles, a 30-day supply. The company did not disclose the drug’s list price, but a spokesperson told FDAnews that it “will be competitively priced” with the leading dry-eye products.

Tyrvaya is expected to compete with existing prescription eye drops, including AbbVie’s Restasis (cyclosporine) and Novartis’ Xiidra (lifitegrast).