Extension study shows efficacy of cyclosporine in treatment of vernal keratoconjunctivitis
The VEKTIS study could bring an important paradigm change in the treatment of this rare but debilitating disease.
An 8-month follow-up extension of the Vernal Keratoconjunctivitis Study, or VEKTIS, showed that continuous use of cyclosporine is safe and effective for the treatment of vernal keratoconjunctivitis in children and adolescents.
“The first and only paper on the use of cyclosporine dedicated to VKC treatment was published in 1986 by Prof. D. BenEzra, and then no clinical randomized studies were published. VKC is a rare eye disease in Europe, and it is commonly seasonal, so it is difficult to have the numbers to perform clinical studies. VEKTIS was a milestone achievement, with potentially a huge impact on the clinical management of this condition,” Dominique Brémond-Gignac, MD, PhD, lead author of the study, said in an interview with Ocular Surgery News.
Vernal keratoconjunctivitis (VKC) is a rare but severe form of allergy, usually presenting in children before 10 years of age. It is more common in temperate zones in the Mediterranean area, the Middle East, Africa, Central America and India and less prevalent in Northern Europe, North America and Australia.
“Symptoms include severe itching, photophobia, mucus discharge and blurry vision. Signs are conjunctival hyperemia, upper tarsal giant papillae, gelatinous infiltrates with Horner-Trantas dots, punctate keratitis and corneal ulcers. In the most severe cases, corneal complications may lead to vision loss,” Brémond-Gignac, head of the department of pediatric ophthalmology at University Hospital Necker-Enfants Malades, Paris, said.
VKC has a heavy impact on everyday life, schoolwork, free time activities and social relationships of the children affected, and symptoms may become chronic, with acute seasonal peaks. Available treatments, such as antihistamines and NSAIDs, have limited efficacy, and corticosteroids can be used only for short periods because of the risk for IOP elevation, cataract and secondary infections.
“Cyclosporine has been used off label in VKC, prepared by hospital pharmacies, prescribed and dispensed only in hospitals. Now we can treat patients with a drug that is on the market and that all ophthalmologists can prescribe, and we have the scientific evidence from two studies that proved safety and efficacy,” Brémond-Gignac said.
Verkazia (Santen), the brand name of the drug, is currently available in the United Kingdom, Denmark, Canada and Austria and is expected to be available soon in France and Italy.
The VEKTIS study was originally a 4-month evaluation of the safety and efficacy of cyclosporine A cationic emulsion (CsA CE) 0.1% eye drops administered four times daily (high dose) or twice daily (low dose) vs. vehicle only. One hundred sixty-nine patients between the ages of 4 and 17 years were included.
The initial 4 months corresponded to what is typically the duration of the allergy season. Following completion of the 4-month evaluation period, 142 patients entered the 8-month follow-up period. Patients in the two active treatment arms remained on their original regimen, while vehicle patients were allocated to one of the two active regimens. The 4-month results showed efficacy of CsA CE in improving keratitis signs and symptoms, particularly in the high-dose group of patients. There was a significant decrease in corneal fluorescein staining score and reduced use of rescue dexamethasone use, as well as improvements in key VKC symptoms and quality of life. Both doses demonstrated favorable safety profiles.
“The further 8-month follow-up in the extension study demonstrated that these benefits can be sustained over time with continued treatment,” Brémond-Gignac said. “The reduction in [corneal fluorescein staining] score was maintained, and the high-dose group showed further improvement from month 4 to month 6. Patients who were switched from vehicle to active treatment also experienced significant improvement.”
The majority of patients, up to more than 92% in the high-dose group, did not need rescue medications.
“Cyclosporine is a steroid-sparing medication, and this is very important because we can avoid the much-dreaded complications of steroids,” Brémond-Gignac said.
Patients continued to experience relief from symptoms, with consequent improvement in quality of life, as assessed by the QUIK questionnaire. CsA CE was well tolerated. The most common treatment-related adverse event was transient pain at the instillation site.
- Bremond-Gignac D, et al. Am J Ophthalmol. 2020;doi:10.1016/j.ajo.2019.11.020.
- Leonardi A, et al. Ophthalmology. 2019;doi:10.1016/j.ophtha.2018.12.027.
- For more information:
- Dominique Brémond-Gignac, MD, PhD, can be reached at Hôpital Universitaire Necker-Enfants Malades, 149 rue de Sèvres, 75743 Paris, France; email firstname.lastname@example.org.
Editor’s note: This article has been updated to reflect expanded availability of Verkazia.