Oyster Point Pharma reports FDA approval of TYRVAYA nasal spray for DED treatment

Oyster Point Pharma, Inc. announced Monday that the U.S. Food and Drug Administration (FDA) has granted approval of its TYRVAYA^TM (varenicline solution) nasal spray 0.03 mg for the treatment of dry eye disease (DED).

As the first — and currently only — nasal spray approved for DED treatment in the U.S., TYRVAYA^TM is a highly-selective cholinergic agonist administered twice a day as an aqueous nasal spray into each nostril.

The nasal spray is designed to activate the trigeminal parasympathetic pathway, resulting in an increased production of basal tear film, according to the company.

Delivery via the nasal is a new form of DED treatment that bypasses medication administration onto an already irritated ocular surface.

Further, nasal delivery may allow some patients who have difficulty independently administering topical eye drops to administer independently their prescribed DED therapy, according to a company news release.

"The approval of TYRVAYA^TM nasal spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose," said Jeffrey Nau, Ph.D., MMS, Oyster Point Pharma president and CEO, in a statement.

Administration of TYRVAYA^TM was analyzed in the ONSET-1, ONSET-2, and MYSTIC clinical trials in more than 1,000 patients exhibiting mild, moderate, or severe DED.

In the ONSET-1 and ONSET-2 trials, 74% of patients were female, the mean (standard deviation [SD]) age was 61 (12) years, the mean (SD) baseline anesthetized Schirmer’s score was 5.1 mm (2.9), and the mean (SD) baseline eye dryness score (EDS) was 59.3 (21.6), the company reported.

According to the news release, criteria for enrollment in the studies included minimal signs and minimal signs [i.e., anesthetized Schirmer's score (range, 0-10 mm) and corneal fluorescein staining (range, 2-14)] and enrollment was not limited by baseline EDS (range, 2-100).

The use of artificial tears was allowed during all three studies.

Basal tear production was measured by the change from baseline in anesthetized Schirmer’s score, and was based on a test utilizing calibrated filtered paper to wick tears and measure tear volume, according to the company.

Eye dryness was also measured by the change from baseline in EDS. Further, EDS was evaluated both in the Controlled Adverse Environment (CAE®) and in the clinic environment.

Patients treated with TYRVAYA^TM showed statistically significant improvements in tear film production (assessed using the anesthetized Schirmer’s score [0-35 mm) at Week 4).

Of these patients, 52% achieved ≥10 mm increase in Schirmer's score from baseline in the ONSET-1 study, and 47% achieved ≥10 mm increase in Schirmer's score from baseline in the ONSET-2 study.

This compared to 14% and 28% of vehicle-treated patients in the ONSET-1 study and the ONSET-2 study, respectively at Week 4 (p<0.01 in both studies), the company reported.

Additionally, of the patients treated with TYRVAYA^TM, the mean change in Schirmer's score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle treated patients in the ONSET-1 study and ONSET-2 study, respectively at Week 4, according to company results.

In the CAE® of the ONSET-1 trial, mean change observed from baseline in EDS at Week 3 was -16.0 mm in 45 patients treated with TYRVAYA^TM compared to -4.44 mm in vehicle-treated patients. The endpoint for this was met p<0.01.

The ONSET-2 trial’s observed mean change from the baseline in EDS at Week 4 was -10.3 mmm in patients treated with TYRVAYA^TM compared to -7.4 mm in vehicle-treated patients. The endpoint for this was not met (p>0.05), the company reported.

In the clinic environment, the ONSET-1 trial showed a mean change from baseline in EDS at Week 4 of -18.9 mm in 255 patients treated with TYRVAYA^TM when compared to -15.4 mm in 248 vehicle-treated patients. The endpoint for this was met (p=0.01)

For the ONSET-2 trial, in the clinic environment, the mean change from baseline to EDS at Week 4 was -19.8 mm in 255 patients treated with TYRVAYA^TM when compared to -15.4 mm in 248 vehicle-treated patients.

Because the CAE® endpoint was not statistically significant, the secondary endpoint for this was not eligible for statistical testing and was not met.

The most commonly adverse reaction that was reported in 82% of participants was sneezing, while 5-16% of patients reported cough, throat irritation, and nose irritation, according to the company.

TYRVAYA^TM will be available for prescription use beginning next month.