Verkazia for the Win

Vernal keratoconjunctivitis (VKC) is a recurrent allergic inflammation of the conjunctiva that is often seen seasonally. It is similar to allergies but more severe than average allergic conjunctivitis. 1 2 Giant papillae, thick discharge, shield ulcers, and severe itching are primary symptoms of VKC and are typically seen in children, though adults can also be diagnosed.

The first FDA-approved therapy for treating VKC is Verkazia 0.1%, a cyclosporine ophthalmic emulsion that acts as a calcineurin inhibitor immunosuppressant. Approved in 2022 under Santen and now owned by Harrow, 3 4 Verkazia works by inhibiting T-cell activation, thereby preventing and reducing the immune cells and inflammatory mediators directly responsible for the inflammation. 2 Some studies have shown Verkazia’s ability to reduce patient signs and symptoms within four weeks, noting declines in tearing, photophobia, and mucus production. 2

Clinical trials such as the VEKTIS and NOVATIVE studies have demonstrated efficacy in reducing corneal inflammation and ocular itching, allowing for an overall improvement in patients’ quality of life. 5 6 Typically, Verkazia is instilled into each affected eye four times a day. 2

The only downside to Verkazia is the transition period during instillation; some patients may experience eye pain or increased itching. However, the benefits outweigh these costs.

There are many alternatives to Verkazia; however, its long-term efficacy makes it favorable among patients. Alternatives include topical corticosteroids, antihistamines, tacrolimus, or other cyclosporine formulations. 11 Often, available treatments like corticosteroids or antihistamines are intended for short-term use or reserved for highly severe cases. Tacrolimus is less preferable than Verkazia due to its uncommon ophthalmic use compared to Verkazia and the potential for a burning sensation upon instillation.

Other alternatives, like Restasis, are used for VKC off-label. It is not specifically formulated for VKC treatment and does not contain the same concentration as Verkazia, which is a 0.05% difference between the two. Verkazia 0.1% is specifically designed in its concentration to actively target VKC, making it a more common therapy for children or patients with severe VKC.

Verkazia has proven its popularity and efficacy for VKC treatment in children and adults, gaining approval globally. Besides the U.S., regions within Europe and select countries in North America and Asia have also approved Verkazia as an effective treatment. 7 8 Its approval marks a significant milestone for the medication, especially given the limited alternatives available in the market.

The global acclaim of Verkazia is credited in part to its safety and efficacy profile, as demonstrated in previous clinical trials. 9 Typically, trials involved children aged 4 to 17 years and demonstrated both short- and long-term efficacy with Verkazia. 9 10 Much of the study highlighted a reduced need for corticosteroids, often used for VKC treatment. This reduction in symptoms and corticosteroid necessity is important, as long-term corticosteroid use is associated with side effects like increased intraocular pressure and cataracts.

Verkazia’s efficacy, combined with its safety profile, provides groundbreaking treatment in ophthalmology, allowing pediatric patients not only within the U.S. but globally to regain their quality of life after being diagnosed with VKC.

1. Bilkhu PS, Naroo SA. Vernal Keratoconjunctivitis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2024. Available from: https://www.ncbi.nlm.nih.gov/books/NBK576433/
2. What Doctors Think About the Verkazia Eye Drop for Vernal Keratoconjunctivitis. Eyes on Eyecare. https://eyesoneyecare.com/resources/what-doctors-think-about-the-verkazia-eye-drop-for -vernal-keratoconjunctivitis/ . Accessed June 5, 2024.
3. Verkazia. Santen. https://www.verkazia.com/ . Accessed June 5, 2024.
4. Santen. Verkazia® (cyclosporine ophthalmic emulsion) 0.1%. Santen Inc. https://www.santen.com/us/business/verkazia#:~:text=Verkazia%C2%AE%20is%20now %20the,may%20access%20through%20this%20site . Accessed June 5, 2024.
5. Verkazia. European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/verkazia . Accessed June 5, 2024.
6. Review of Optometry. Topical Immunomodulator Approved for Vernal Keratoconjunctivitis. https://www.reviewofoptometry.com/article/topical-immunomodulator-approved-for-vern al-keratoconjunctivitis . Accessed June 5, 2024.
7. Santen Receives FDA Approval for Verkazia™ (Cyclosporine Ophthalmic Emulsion) 0.1% for the Treatment of Vernal Keratoconjunctivitis in Children and Adults. Business Wire. https://www.businesswire.com/news/home/20210624005365/en/Santen-Receives-FDA-A pproval-for-Verkazia%E2%84%A2-Cyclosporine-Ophthalmic-Emulsion-0.1-for-the-Trea tment-of-Vernal-Keratoconjunctivitis-in-Children-and-Adults. Published June 24, 2021. Accessed June 5, 2024.
8. FDA Approves Verkazia for Treatment of Vernal Keratoconjunctivitis. OphthalmologyWeb. https://www.ophthalmologyweb.com/1315-News/577174-FDA-Approves-Verkazia-for-T reatment-of-Vernal-Keratoconjunctivitis/. Accessed June 5, 2024.
9. Verkazia (Cyclosporine Ophthalmic Emulsion) 0.1% – Drug Information. Drugs.com. https://www.drugs.com/pro/verkazia.html . Accessed June 5, 2024.
10. FDA Approves Cyclosporine A Drop for Vernal Keratoconjunctivitis. Ophthalmology Times. https://www.ophthalmologytimes.com/view/fda-approves-cyclosporine-a-drop-for-vernal -keratoconjunctivitis . Accessed June 5, 2024.
11. Vernal Keratoconjunctivitis. NORD (National Organization for Rare Disorders). https://rarediseases.org/rare-diseases/vernal-keratonconjunctivitis/. Accessed June 5, 2024.