Oyster Point Pharma announced Monday that the FDA has approved Tyrvaya, a nasal spray formulation of the cholinergic agonist varenicline, to treat signs and symptoms of dry-eye disease. The company said Tyrvaya, which will be available with a prescription starting in November, is delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production by activating the trigeminal parasympathetic pathway.
The filing was supported by results from the Phase III ONSET-1 and ONSET-2 studies, as well as the mid-stage MYSTIC trial, in over 1000 patients with mild, moderate or severe dry-eye disease. The company said Tyrvaya-treated patients saw significant improvements on the primary endpoint of tear film production, based on the anaesthetised Schirmer's score at week four. Results showed that 52% of Tyrvaya-treated patients achieved ≥10 mm increase in Schirmer's score from baseline in ONSET-1, and 47% did so in ONSET-2, compared to 14% and 28% of vehicle-treated patients in each study, respectively.
Meanwhile, the secondary goal of eye dryness score was tested both in the controlled adverse environment (CAE) and clinic settings. In the clinic environment, that endpoint was met in ONSET-1, where there was a mean change of -18.9 mm in eye dryness score from baseline to week four among Tyrvaya-treated patients, compared to -5.4 mm for vehicle. This endpoint was not met in ONSET-2, but Oyster Point explained that as it had not been met in the CAE, it was not eligible for statistical testing in the clinic setting.
Oyster Point said the nasal route provides a new way to treat dry-eye disease without having to administer medication onto an already irritated ocular surface. It added that nasal delivery will also allow patients who have difficulty giving themselves topical eye drops to administer their prescribed dry-eye disease therapy independently.
CEO Jeffrey Nau said the approval "marks a milestone for patients and eye-care professionals by providing a new drug treatment option…with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose." The company noted that the most common adverse reaction reported in 82% of patients was sneezing, while other events that occurred in 5% to 16% of patients were cough, throat irritation and nose irritation.
Tyrvaya will come in cartons containing two multi-dose nasal spray bottles, each covering treatment for 15 days, administered twice daily into each nostril. The drug's active ingredient, varenicline, is also used in Pfizer's smoking cessation product Chantix.
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