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Oyster Point's (OYST) Tyrvaya Gets FDA Nod for Dry Eye Disease

Oyster Point Pharma, Inc. OYST announced that the FDA has approved its nasal spray Tyrvaya (varenicline solution) for the treatment of patients with signs and symptoms of dry eye disease.

Following the FDA nod, Tyrvaya became the first and only nasal spray to be approved for the given indication. Tyrvaya nasal spray will hit the market in the United States from next month.

The approval of Tyrvaya (0.03 mg) nasal spray was based on data from several studies that evaluated more than 1,000 patients with mild, moderate or severe dry eye disease. Tyrvaya nasal spray was investigated in the ONSET-1, ONSET-2 and MYSTIC clinical studies.

Patients who were treated with Tyrvaya nasal spray demonstrated statistically significant improvements in tear film production as seen using the anesthetized Schirmer's score at week four of treatment.

Shares of Oyster Point have plunged 26.3% so far this year compared with the industry’s decline of 10.9%.

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Last December, the company submitted the new drug application for Tyrvaya nasal spray to the FDA for the treatment of signs and symptoms of dry eye disease.

We note that Oyster Point is focused on the development and commercialization of first-in-class therapies to address ophthalmic diseases. The company is also evaluating Tyrvaya nasal spray in the phase II OLYMPIA study for the treatment of stage 1 neurotrophic keratopathy, a rare corneal disease.

Till now, Oyster Point has had no approved product in its portfolio. As a result, the successful commercialization of Tyrvaya remains critical for the company’s long-term growth as it will able to generate revenues from product sales.

Zacks Rank & Stocks to Consider

Oyster Point currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector include Fulcrum Therapeutics, Inc. FULC, Athenex, Inc. ATNX and Amicus Therapeutics, Inc. FOLD, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Fulcrum Therapeutics’ loss per share estimates have narrowed 7.4% for 2021 and 10% for 2022, over the past 60 days. The stock has soared 96.8% year to date.

Athenex’s loss per share estimates have narrowed 9% for 2021 and 9.2% for 2022, over the past 60 days.

Amicus Therapeutics’ loss per share estimates have narrowed 1.3% for 2021 and 37.5% for 2022, over the past 60 days.

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