Santen’s VEKTIS study demonstrates efficacy and tolerability of cyclosporine A cationic emulsion in pediatric vernal keratoconjunctivis, over 12 months

Santen EMEA is delighted to announce that the results of VEKTIS, a twelve month study in pediatric vernal keratoconjunctivitis (VKC) have been published in the American Journal of Ophthalmology. The study demonstrates that cyclosporine A 0.1% cationic emulsion (CsA CE, Verkazia^®) provides improvements in symptoms and quality of life measures, whilst maintaining a stable safety profile over an 8-month follow-up period in patients aged 4 to 17 years. Four-month efficacy data for CsA CE in VKC have previously been published in Ophthalmology in May 2019.

The VEKTIS data illustrate that cyclosporine A 0.1% cationic emulsion provide physicians with an effective and reliable way to manage the signs and symptoms of VKC with their pediatric patients. The data are particularly encouraging, given the significant impact that this allergic disease can have on the lives and development of children effected.”

Prof Dominique Bremond-Gignac, Principal Investigator, VEKTIS

VEKTIS (VErnal KeratoconjunctiviTIs Study), a multi-center, double-masked, randomized safety follow-up controlled study in VKC, evaluated the ongoing safety profile of CsA CE in 169 patients aged 4-17 years in the US, India, Israel, Spain, France, Italy, Greece, Hungary, Portugal, Croatia and Germany. Of the 169 patients, 142 entered the 8-month follow-up period, during which CsA CE patients remained on their original regimen (CsA CE four times daily [QID, high-dose] or CsA CE twice daily [BID, low-dose] + vehicle BID). Vehicle patients were allocated to one of these two active regimens. The key findings of this study included:

• Improvements in corneal fluorescein staining (CFS) score, rescue medication use and key VKC symptoms (photophobia, tearing, itching, and mucous discharge);
• A resultant improvement in quality of life (QoL) assessed by QUICK questionnaire observed that CsA CE compared with vehicle during the 4-month evaluation period remained stable during the 8-month follow-up period, with the high-dose regimen continuing to provide greater benefits in most efficacy measures;
• CsA CE was well tolerated. Treatment-related treatment-emergent adverse events during the 12-month study were reported in 15 (20.8%) and 11 (15.7%) of the CsA CE high-dose and low-dose patients, respectively, most commonly instillation site pain (13.9% and 7.1%, respectively);
• Laboratory data, vital signs, slit lamp examination, best-corrected distance visual acuity and intraocular pressure raised no safety concerns.

VKC is a rare but severe form of ocular allergic conjunctivitis, which sadly, disproportionally affects children, presenting before 10 years of age in 80% of cases, with boys affected 2-4 times more often than girls. The condition, which in 25%-50% cases causes persistent keratitis and other corneal complications leading potentially to vision loss, is characterized by allergic inflammation of the ocular surface, with key signs and symptoms including photophobia, conjunctival hyperemia, itching, stringy mucous discharge, giant papillae on the upper tarsal conjunctiva, gelatinous infiltrates on the corneoscleral limbus with white-yellow nodules, superficial punctate keratitis, and corneal shield ulcers. Severe VKC may cause limitations in daily activities, school work and psychosocial relationships, thereby adversely affecting health-related quality of life (QoL).

As a global specialist in ophthalmology, we know that it is our duty to continue to investigate treatments to support patients across the ophthalmic spectrum, particularly in those with rare conditions. We would like to thank the children who participated in the VEKTIS study. With their help, we have been able to learn more about how cyclosporine A cationic emulsion can be used to alleviate the symptoms of this disease, and help children all around the world live healthier and happier lives.”

Luis Iglesias, Head of Santen EMEA