Harrow Acquires Global Rights To Tyrvaya
Harrow has entered into a definitive agreement with Viatris to acquire the global rights to Tyrvaya (varenicline solution) nasal spray 0.03 mg, a prescription treatment for the signs and symptoms of dry eye disease (DED). Announced August 6, 2026, the deal is valued at up to $100 million, consisting of a $30 million upfront cash payment and as much as $70 million in additional milestone payments based on Tyrvaya’s future net sales. Harrow expects the transaction to close during the second half of 2026, pending customary closing conditions. The acquisition represents a significant expansion of Harrow’s dry-eye portfolio and gives the company control of what the article describes as the only FDA-approved nasal spray for dry eye disease.
Tyrvaya is particularly distinctive because, unlike conventional dry-eye medications that are administered directly to the eye, it is delivered through the nose. Varenicline is a cholinergic agonist that binds to nicotinic acetylcholine receptors in the nasal mucosa. This activates the trigeminal parasympathetic, or nasolacrimal, pathway and stimulates the body’s natural production of basal tears. Tyrvaya was originally developed by Oyster Point Pharma and received FDA approval in October 2021. Viatris subsequently acquired Oyster Point in 2023, bringing Tyrvaya into its ophthalmology portfolio. Under the new agreement, Harrow will take over the global rights, building on the product’s existing regulatory approvals in the United States, China, and Taiwan, with applications pending in additional countries.
The acquisition is especially important because Tyrvaya complements Vevye (cyclosporine ophthalmic solution 0.1%), Harrow’s existing branded dry-eye treatment. Vevye is a topical anti-inflammatory medication designed to address the inflammatory component of chronic dry eye, whereas Tyrvaya works by stimulating tear production. Harrow therefore sees the two products as complementary therapies that could potentially be used independently or together depending on a patient’s needs. The combination also gives Harrow two different approaches to treating DED: one targeting inflammation on the ocular surface and another stimulating the body’s natural tear-production pathway. However, the article emphasizes that there is no clinical evidence yet demonstrating that using the two products together provides an additive benefit.
Clinical evidence supporting Tyrvaya comes primarily from the ONSET-1 and ONSET-2 trials, along with the supportive MYSTIC study, which collectively enrolled more than 1,000 adults with mild-to-severe dry eye disease. In the phase 3 ONSET-2 study, 47% of patients receiving the 0.03-mg dose achieved at least a 10-mm improvement in Schirmer test results, compared with 28% receiving the vehicle treatment. ONSET-1 produced an even larger difference, with 52% of patients on Tyrvaya reaching that threshold versus 14% with vehicle. The most common adverse reaction was sneezing, reported in approximately 82% of patients. Other reported reactions included coughing, throat irritation, and nasal irritation. The article notes, however, that these trials primarily demonstrate improvements in tear production, and questions remain regarding long-term symptom improvement and how Tyrvaya compares directly with established topical therapies.
From an industry perspective, the acquisition represents more than simply another product added to Harrow’s portfolio. It strengthens the company’s position in the growing dry-eye market by combining two branded prescription therapies with fundamentally different mechanisms of action. Tyrvaya may also be particularly attractive to certain patients who have difficulty tolerating topical eye drops or who wear contact lenses, since its nasal administration does not require contact lenses to be removed. At the same time, the article cautions that it is still too early to conclude that nasal administration necessarily improves patient adherence or outcomes compared with eye drops. Overall, Harrow’s acquisition signals a strategic effort to build a more comprehensive dry-eye franchise, while giving eye-care professionals another treatment option for a disease that often requires individualized, multi-faceted management.
To learn more:
https://www.optometrytimes.com/view/harrow-acquires-global-rights-to-tyrvaya
