Harrow acquires global rights to Tyrvaya

Harrow (Nasdaq: HROW) has entered a definitive agreement to acquire global rights to varenicline solution nasal spray 0.03 mg (Tyrvaya) from Viatris, positioning the company to offer clinicians 2 distinct branded prescription therapies for dry eye disease (DED).¹ The Nashville-based ophthalmic company announced the deal August 6, 2026, framing it as an expansion of a dry eye franchise anchored by its cyclosporine product, Vevye.¹

For eye care clinicians, the transaction is notable less for its financial structure than for what it signals about the branded DED treatment landscape: a first-line topical cyclosporine and the only FDA-approved nasal spray for DED are now being marketed by a single commercial organization, a consolidation that may influence prescribing patterns and patient access.

The transaction

Under the agreement, Harrow will pay $30 million in cash at closing plus up to $70 million in contingent milestone payments tied to varenicline solution nasal spray 0.03 mg net sales, for a potential total consideration of up to $100 million.¹ The company said it expects to fund the upfront payment from cash on hand and to close the transaction in the second half of 2026, subject to customary closing conditions.¹ Varenicline solution nasal spray 0.03 mg is currently approved in the United States, China, and Taiwan, with marketing authorization applications pending in additional countries.¹

Varenicline solution nasal spray 0.03 mg reached Harrow through a chain of ownership changes. It was developed by Oyster Point Pharma, which secured FDA approval in October 2021.^2,3 Viatris acquired Oyster Point in early 2023, folding the product into its ophthalmology unit before this divestiture to Harrow.⁴

Drug and mechanism background

Varenicline solution nasal spray is a cholinergic agonist indicated for the treatment of the signs and symptoms of DED.^1,5 Rather than acting on the ocular surface, the drug binds nicotinic acetylcholine receptors in the nasal mucosa to activate the trigeminal parasympathetic (nasolacrimal) pathway, stimulating basal tear film production.^3,5 This route of administration distinguishes it from topical DED therapies and, per the product labeling, allows dosing without contact lens removal.^1,5

Harrow's existing anchor product, cyclosporine ophthalmic solution 0.1% (Vevye), addresses the inflammatory component of DED and was FDA approved in 2023.^6,7 The company positions the two products as complementary: an anti-inflammatory topical for chronic disease and a tear-stimulating nasal spray that may be used alone or as an adjunct.¹

Trial evidence

FDA approval of varenicline nasal spray was supported by the phase 2b ONSET-1 and phase 3 ONSET-2 randomized, multicenter, double-masked, vehicle-controlled trials, together with the MYSTIC study, enrolling more than 1,000 adults with mild-to-severe DED.^3,5,8 The pivotal ONSET-2 trial randomized 758 patients with an Ocular Surface Disease Index score of 23 or higher and a Schirmer test score of 10 mm or less to varenicline 0.03 mg, 0.06 mg, or vehicle, 1 spray per nostril twice daily.⁸

The primary end point was the proportion of patients achieving a 10 mm or greater improvement in anesthetized Schirmer score from baseline. In ONSET-2, 47% of patients treated with the 0.03 mg dose met this threshold versus 28% of vehicle-treated patients; the corresponding figure in ONSET-1 was 52% versus 14%.^3,8 The most common adverse reaction was sneezing, reported in approximately 82% of patients; cough, throat irritation, and instillation-site (nasal) irritation were each reported in 5% to 16% of patients.^1,5,8

Clinical context

DED is a common, multifactorial disorder of the ocular surface characterized by loss of tear film homeostasis and accompanied by ocular symptoms, in which tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities play etiological roles, per the TFOS DEWS II definition.⁹ Because the condition is heterogeneous, management is often individualized and may combine artificial tears, anti-inflammatory agents, and secretagogues.

A recurring practical limitation of topical therapy is tolerability. Instillation-site reactions are among the most common adverse events with ophthalmic cyclosporine; Vevye's own labeling lists instillation-site reactions (8%) as its most frequent adverse reaction.¹ A drop-free option may be relevant for patients who cannot tolerate topical drops or who wear contact lenses, a population the US Centers for Disease Control and Prevention estimates at more than 45 million adults.^1,10 Whether nasal delivery meaningfully improves adherence over topical therapy in routine practice has not been established in head-to-head trials.

Interpretation and limitations

The acquisition is a commercial and portfolio development rather than new clinical evidence; it introduces no new efficacy or safety data. The efficacy signal for varenicline nasal spray rests primarily on a sign-based endpoint (Schirmer score), and the durability of symptom benefit and comparative effectiveness against established topical therapies remain open questions. The company's characterization of the two products as complementary reflects mechanism of action but should not be read as evidence of additive clinical benefit, which has not been formally studied.

Claims made in the announcement—including expectations that the product will be financially accretive and assertions about promotional awareness among prescribers—originate with the sponsor and reflect corporate rather than clinical objectives. Clinicians evaluating varenicline nasal spray should rely on the peer-reviewed ONSET trial data and current product labeling.

References

1. Harrow, Inc. Harrow acquires global rights to Tyrvaya, the first and only FDA-approved nasal spray for dry eye disease. News release. GlobeNewswire. August 6, 2026. Accessed August 7, 2026. https://www.globenewswire.com/news-release/2026/08/06/3340081/0/en/Harrow-Acquires-Global-Rights-to-TYRVAYA-the-First-and-Only-FDA-Approved-Nasal-Spray-for-Dry-Eye-Disease.html

2. Oyster Point Pharma announces FDA approval of Tyrvaya (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry eye disease. News release. BioSpace. October 2021. Accessed August 7, 2026. https://www.biospace.com/oyster-point-pharma-announces-fda-approval-of-tyrvaya-varenicline-solution-nasal-spray-for-the-treatment-of-the-signs-and-symptoms-of-dry-eye-disease

3. Krader CG. Varenicline nasal spray approved as a treatment for dry eye disease. Ophthalmology Times. November 17, 2021. Accessed August 7, 2026. https://www.ophthalmologytimes.com/view/varenicline-nasal-spray-approved-as-a-treatment-for-dry-eye-disease

4. Hutton D. Viatris making ophthalmology push with acquisition of Oyster Point Pharma. Ophthalmology Times. November 7, 2022. Accessed August 7, 2026. https://www.ophthalmologytimes.com/view/viatris-making-ophthalmology-push-with-acquisition-of-oyster-point-pharma

5. Tyrvaya (varenicline solution) nasal spray. National Drug Monograph, US Department of Veterans Affairs. November 2022. Accessed August 7, 2026. https://www.va.gov/formularyadvisor/DOC_PDF/MON_Varenicline_Nasal_Spray_TYRVAYA_Monograph_Nov_2022.pdf

6. Novaliq announces FDA approval of Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease. News release. Novaliq. June 8, 2023. Accessed August 7, 2026. https://www.novaliq.com/press-releases/2023/06/08/novaliq-announces-fda-approval-of-vevye-cyclosporine-ophthalmic-solution-0-1-for-the-treatment-of-the-signs-and-symptoms-of-dry-eye-disease/

7. Vevye (cyclosporine ophthalmic solution) 0.1% prescribing information. NDA 217469. US Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217469s000lbl.pdf

8. Wirta D, Vollmer P, Paauw J, et al. Efficacy and safety of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease: the ONSET-2 phase 3 randomized trial. Ophthalmology. 2022;129(4):379-387. https://www.aaojournal.org/article/S0161-6420(21)00836-8/fulltext

9. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276-283. doi:10.1016/j.jtos.2017.05.008. https://www.sciencedirect.com/science/article/pii/S1542012417301192

10. Centers for Disease Control and Prevention. About contact lenses. Healthy contact lens wear and care. Updated May 8, 2024. https://www.cdc.gov/contact-lenses/about/index.html