Tyrvaya from Oyster Point (OYST) gets FDA green light for dry eye – October 19, 2021


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

Following FDA approval, 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 nasal spray (0.03 mg) was based on data from several studies that evaluated over 1000 patients with mild, moderate or severe dry eye. Tyrvaya nasal spray has been studied in the ONSET-1, ONSET-2 and MYSTIC clinical studies.

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

Oyster Point shares have plunged 26.3% so far this year from the industry’s 10.9% decline.

Image source: Zacks Investment Research

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

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

Until now, Oyster Point had no approved products in its portfolio. As a result, the successful commercialization of Tyrvaya remains essential for the long-term growth of the business, as it will be able to generate income through the sale of products.

Zacks ranking and actions to take into account

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

Some top-ranked stocks in the biotech sector include Fulcrum Therapeutics, Inc. (FULC Free report), Athenex, Inc. (ATNX Free report) and Amicus Therapeutics, Inc. (TO FOLD Free Report), all currently carrying a Zacks Rank # 2 (Buy). You can see The full list of Zacks # 1 Rank (Strong Buy) stocks today here.

Fulcrum Therapeutics’ loss per share estimates have declined 7.4% for 2021 and 10% for 2022, over the past 60 days. The stock has climbed 96.8% since the start of the year.

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

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


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