Harrow is expanding its arsenal of dry eye products with the acquisition of Viatris, Inc.’s FDA-approved TYRVAYA (varenicline solution) nasal spray 0.03 mg.
Are we talking about a complete, all-encompassing acquisition of this product?
Indeed—this deal constitutes the global rights to TYRVAYA.
Give me the rundown on it.
What it is: A cholinergic agonist granted FDA approval in October 2021 as the first and only prescription-based nasal spray indicated to treat the signs and symptoms of dye eye disease (DED).
- Per its prescribing information, the recommended dosage is one 0.3 mg of spray in each nostril twice daily (BID), approximately 12 hours apart.
- Due to its spray (rather than drop) delivery, its PI includes no contraindications nor warnings or precautions—with sneezing as the most common adverse reaction.
- See here for its official product website.
And as of today: It has received approval in the U.S., China, and Taiwan—with marketing authorization applications currently pending in other countries.
And take note: TYRVAYA was originally developed by Oyster Point Pharma before being acquired by Viatris in early 2023 as part of an estimated $415 million deal.
Speaking of deals … let’s talk about this new one.
Per the terms of its definitive agreement with Viatris, Harrow will:
- Pay $30 million in cash at closing
- Pay up to $70 million in contingent milestone payments tied to TYRVAYA’s net sales
- Equating to a potential total consideration of up to $100 million
Notably, the company plans to fund that upfront cash payment with cash on hand.
And when is the transaction expected to close?
Ideally, within the second half (H2) of 2026, subject to customary closing conditions.
Translation: Sometime between now and Dec. 31.
Tell me about Harrow’s existing dry eye portfolio.
The company’s dry eye portfolio already includes the prescription-based VEVYE (cyclosporine ophthalmic solution) 0.1%, which it acquired from Novaliq GmbH just one month after receiving FDA approval in 2023.
- That purchase came with its own significance in the dry eye space, as the drop’s approval marked it as the first and only cyclosporine solution indicated to treat the signs and symptoms of DED, with an efficacy demonstrated at just 4 weeks (in clinical evaluations).
And how does TYRVAYA fit into this?
It’s expected to complement that “flagship VEVYE franchise,” according to the company, and can be prescribed separately from (or in addition to) VEVYE.
How: By TYRVAYA “addressing DED with a different underlying mechanism of action” from VEVYE:
- VEVYE addresses the inflammatory component of DED.
- TYRVAYA stimulates the body’s natural basal tear production within minutes of the first dosing.
Nice! Now let’s talk availability—will there be any major changes?
Not as far as we can tell … eyecare providers can get started with prescribing TYRVAYA through two dispensing routes—PhilRx or a local retail pharmacy—by clicking here
Also, details on its patient accessibility program are also worth checking out.