Riboflavin Ophthalmic Solution activated in situ with a novel scanning laser-based bioactivation system, the NXL UV-A device, demonstrates safety of corneal cross-linking for the treatment of keratoconus

Abstract

Purpose : Current UV cross-linking LED-based technologies expose the entirety of the treatment zone throughout the treatment, leading to oxygen depletion. Therefore, this study was conducted to evaluate the safety of Riboflavin Ophthalmic Solution 1 and Riboflavin Ophthalmic Solution 2 activated in situ with a novel third-generation, scanning laser-based bioactivation system, the NXL UV-A device, at 3 dose levels for corneal cross-linking in subjects with keratoconus.

Methods : This open-label, prospective study enrolled 12 subjects, 18 years or older, in 2 cohorts. Subjects in Cohort 1 (N=3) had at least one functionally blind (or partially sighted) eye with healthy corneas. Subjects in Cohort 2 (N=9) had keratoconic eyes with functional vision. Cohort 1 subjects were treated with epithelium-on corneal collagen cross-linking using the NXL UV-A device at a high UV dose and Riboflavin Ophthalmic Solution 1 and Riboflavin Ophthalmic Solution 2. Cohort 2 subjects received epithelium-on corneal collagen cross-linking using Riboflavin Ophthalmic Solution 1 and Riboflavin Ophthalmic Solution 2, with 3 subjects each receiving a low, medium, and high dose from the NXL UV-A device in a dose-escalating manner. Safety review, prior to moving from Cohort 1 to Cohort 2 and prior to dose escalation within Cohort 2, occurred after subjects treated with the current dose completed Day 5. All subjects will be followed for 12 months post-treatment to evaluate safety [including slit lamp and optical coherence tomography (OCT)] and adverse events. Efficacy will be evaluated in Cohort 2.

Results : At the time of this abstract, 100% of subjects completed at least 1 month of follow up, 58% completed 3 months of follow up, and 17% completed 6 months of follow up. All subjects are still ongoing follow up. Slit lamp findings and adverse events were generally mild in nature, transient, and similar to those observed in standard crosslinking treatments.

Conclusions : Using a novel scanning laser-based bioactivation system, the NXL UV-A device, for corneal cross-linking in subjects with keratoconus is safe and well tolerated at all tested doses to date.

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