TYRVAYA's Novel Nasal Route Buys Differentiation, But Payer Evidence Bar Remains Uncleared

Harrow Completes Acquisition of TYRVAYA for Dry Eye Disease

Harrow, Inc. has completed its acquisition of TYRVAYA® (varenicline solution) nasal spray 0.03 mg from Viatris Inc. for an upfront cash payment of $30 million, with potential contingent milestone payments up to $70 million, totaling up to $100 million. This acquisition grants Harrow worldwide rights to TYRVAYA, excluding Japan, and significantly expands its ocular surface franchise for dry eye disease, complementing its existing product VEVYE®. TYRVAYA is the first and only FDA-approved nasal spray for dry eye disease and is expected to contribute over $30 million in revenue in 2027.

• Harrow completed the acquisition of TYRVAYA from Viatris for an upfront cash payment of $30 million, with potential contingent milestone payments up to $70 million, bringing the total potential consideration to $100 million. Harrow secured worldwide rights to TYRVAYA, excluding Japan, where Viatris retains commercialization rights and will pay royalties to Harrow.
• The addition of TYRVAYA significantly strengthens Harrow's presence in the U.S. dry eye market, complementing its existing flagship product, VEVYE. This provides eyecare professionals with two distinct, differentiated prescription therapies—a nasal spray and an ophthalmic solution—to individualize treatment for patients with dry eye disease, enhancing Harrow's comprehensive ocular surface portfolio.
• Harrow expects to integrate approximately 40 experienced Viatris personnel, expanding its Ocular Surface commercial team to support both TYRVAYA and VEVYE. This expanded team, combined with TYRVAYA's established prescriber base and Harrow's dedicated infrastructure, is projected to drive significant growth, with TYRVAYA alone expected to contribute over $30 million in revenue in 2027.

Addressing Unmet Needs in the Evolving Dry Eye Disease Landscape

Despite meaningful advances in dry eye disease (DED) therapeutics, significant gaps remain in achieving consistent, durable symptom and sign control across the heterogeneous patient population. The disconnect between clinical signs and patient-reported symptoms continues to complicate both treatment selection and outcome assessment.

• Symptom-sign discordance is pervasive and multifactorial. In the DREAM study cohort of 535 patients with moderate to severe DED, 77% were discordant using a rank-based method, with symptom-dominant discordance (37.8%) associated with younger age and greater ocular discomfort, and sign-dominant discordance (39.3%) more prevalent in patients with Sjögren's syndrome. Temporal analysis further revealed that 46% of patients had discordant symptom-sign trajectories over 9 months. Systemic factors — including female sex, higher bodily pain scores, antidepressant use, and chronic pain syndromes — independently predict the direction of discordance, underscoring the need for individualized patient stratification rather than uniform treatment protocols.

• Corticosteroids carry significant long-term safety liabilities. While corticosteroids remain effective for controlling acute ocular surface inflammation, prolonged use is associated with elevated intraocular pressure, cataract formation, and infection risk, limiting their utility in the chronic management of DED.

• Targeted immunomodulatory agents present their own adherence and tolerability challenges. Topical cyclosporine A (CsA) — available as Restasis (0.05%), Cequa (0.09%), and Vevye (0.1%) — demonstrates long-term efficacy across corneal fluorescein staining, Schirmer's test scores, and tear break-up time, yet is hampered by delayed onset of action, transient irritation, and high discontinuation rates. In a head-to-head evaluation of TJO-087 (0.08% CsA nanoemulsion, once daily) versus conventional 0.05% CsA (twice daily), both groups showed significant improvement in OSDI, TBUT, ocular surface staining, and Schirmer test scores at 32 weeks, with no difference in the extent of improvement across efficacy parameters — though the itching score was higher in the TJO-087 group at week 8.

• MGD-directed physical therapies are effective but access-limited. Device-based interventions such as thermal pulsation systems (e.g., LipiFlow®) and intense pulsed light (IPL) typically offer greater and more long-lasting improvements than conventional warm compresses or eyelid cleansing, but are constrained by cost, access, and a lack of long-term safety data. Critically, no current MGD treatment can regenerate affected meibomian glands — secreting function can be improved, but structural gland loss is not reversible.

• Chronic sub-clinical inflammation perpetuates a self-sustaining disease cycle. Dysregulated para-inflammation — driven by persistent external or internal stressors — can progress to full-blown chronic ocular surface inflammation, causing ongoing epithelial damage and DED progression. Long-term management must address these persistent pathogenic drivers, yet the prolonged use of anti-inflammatory molecules required to re-equilibrate ocular surface homeostasis must be balanced against cumulative safety risks.

Harrow's Bold Bid for Dry Eye Market Dominance

Harrow's strategic acquisition of TYRVAYA (varenicline solution) nasal spray marks a pivotal moment in the evolving dry eye disease (DED) treatment landscape. This move not only broadens Harrow's ocular surface franchise but also introduces a fundamentally different approach to DED management. Unlike traditional eye drops, TYRVAYA leverages neuroactivation of the nasolacrimal reflex via a nasal spray, offering a unique mechanism to stimulate natural tear production. This distinct delivery method and mode of action could be a significant differentiator in a crowded market, appealing to patients who struggle with topical drop administration or seek alternative therapeutic pathways.

However, this strategic expansion comes with its own set of considerations. While clinical trials consistently demonstrate TYRVAYA's efficacy in increasing tear production, with a rapid onset of action, its impact on patient-reported symptoms and corneal staining has shown less consistent statistical significance. Furthermore, the product is associated with a high incidence of non-ocular adverse events, such as sneezing and cough, which, despite being generally mild, could influence patient compliance. Harrow will need to carefully navigate these factors, potentially positioning TYRVAYA as a complementary therapy or for specific patient populations.

This acquisition positions Harrow with a diversified DED portfolio, now encompassing both a novel neuroactivator and its existing semifluorinated alkane-based cyclosporine A formulation, VEVYE®. This dual offering allows Harrow to address DED from multiple angles, potentially enabling combination therapies or sequential treatment strategies tailored to individual patient needs. The success of this venture will hinge on effective market education, demonstrating the unique benefits of a nasal spray for DED, and managing patient expectations regarding its specific efficacy profile and tolerability.