Harrow is reintroducing VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, indicated for the treatment of vernal keratoconjunctivitis (VKC), to the U.S. commercial market.
First thing’s first: Tell us about VERKAZIA.
What it is: A prescription-based calcineurin inhibitor immunosuppressant formulated as an ophthalmic emulsion intended for topical administration. Its indication: For the treatment of VKC in children and adults. See its prescribing information (PI) for:
- Recommended dosage
- Warnings and precautions
- Potential adverse reactions
- Clinical study data
Its claim to fame: VERKAZIA is the first and only topical immunomodulator FDA-approved for pediatric patients with VKC.
And as Harrow noted: “Prior to VERKAZIA, no FDA-approved steroid-sparing therapy existed for VKC, leaving a substantial gap in care for both mild and severe patients.”
Alrighty, now let’s revisit this reintroduction to the U.S. market.
The prescription therapy was originally developed by Santen Inc. (the U.S. subsidiary of Santen Pharmaceuticals Co. Ltd.) and granted FDA approval in June 2021.
Fast forward to May 2022: VERKAZIA first launched to the U.S. market (under the Santen name).
How did Harrow come into play?
In July 2023: Harrow announced its acquisition of North American commercial rights for VERKAZIA, along with several other ophthalmic products in the Santen portfolio.
And by October 2023: The company completed its transfer of these products’ (including VERKAZIA’s) new drug applications (NDAs).
Also worth noting: In February 2024, Harrow out-licensed the Canadian rights to VERKAZIA, along with four other ophthalmic products, to Apotex Inc., a Canadian-based pharma company.
And what’s the expectation for VERKAZIA’s return?
Despite the company reporting inventory shortages in late 2025 (that carried over to the beginning of 2026) and the quarter’s financial numbers—described as not reflecting “the true state of our business,” according to Harrow’s Q1 2026 earnings review—projections are overwhelmingly positive.
In writing to Harrow shareholders, CEO Mark L. Baum shared expectations for sequential growth throughout the rest of this year: “We are entering a period of accelerating commercial execution.”
- Looking at VERKAZIA specifically: The therapy is one of three “priority” products being launched and positioned with “the potential to unlock new on-label markets” as well as “contribute meaningful incremental revenue.”
Go on …
Harrow noted that VERKAZIA is supported by a "comprehensive commercial strategy” to ensure its availability across the country:
“Our focus with this re-launch is straightforward: ensure dependable supply, remove access barriers, and enable physicians and patients to reliably obtain this important, evidence-based, and, most importantly, steroid-sparing treatment, for long-term disease management,” he stated.
So! When and where will this be available?
Eyecare providers interested in prescribing VERKAZA can click here or reach out to the company at 1-833-4HARROW (1-833-442-7769).
For all other product details, head over to VERKAZIA’s website.