KIO-201, a Crosslinked, Chemically Modified Form of Hyaluronic Acid, Improves Wound Healing in Patients with Persistent Corneal Epithelial Defects

Abstract

Purpose : Hyaluronic acid (HA) is a naturally occurring polysaccharide, often used in tear supplements, that is found in increased quantities during ocular wound healing processes, including Persistent Corneal Epithelial Defects (PCEDs). Since endogenous HA is cleared rapidly from the ocular surface, this limits its utility to aid in corneal wound healing. KIO-201 is a crosslinked, chemically modified HA, providing enhanced shear-thinning capabilities, enabling more drug to be delivered and a longer ocular surface residence time.

Methods : This prospective, open-label, single center study treated nine eyes in 8 subjects diagnosed with Stage 1 and Stage 2 PCED. Subjects received KIO-201 with a dosing regimen of 6 times per day over 4 weeks. The primary endpoint was epithelial healing to a lesion size of <0.5mm².

Results : Eight eyes were evaluable by repeated fluorescein staining after at least 3 weeks of treatment and the authors report a 90.0% least square mean reduction in defect size at 4 weeks (10.28 mm² ± 1.45 SEM from baseline to 1.16 mm² ± 1.58 SEM at 4 weeks; p<0.0008). Five (5) of 8 (62.5%) of the evaluable subjects achieved the primary endpoint of healing over the 4-week period. The greatest reduction in defect size occurred in Week 1 of therapy, and a statistically significant reduction (p<0.003) in mean defect size was observed from baseline through days 7, 14, 21, and 28. One subject was lost to follow-up, 1 subject had a completely healed defect at the time of baseline evaluation, and 1subject’s eye was determined to have a corneal perforation after 1 week secondary to underlying severe dry eye disease (patient’s contralateral eye was successfully treated). The drug was safe and well tolerated with a total of 6 non-serious adverse events (eye discomfort, change in vision, perforation, and ocular culture negative infection) reported in 2 patients. All AEs were reported by investigators to be unrelated to study drug.

Conclusions : PCEDs are a challenging disorder requiring aggressive interventions as they can lead to infections, stromal ulceration, corneal scarring, and opacification resulting in vision loss. KIO-201 is a potential treatment that could aid in the complex healing process of PCEDs.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.