Cyclosporine Intracanalicular Insert Successful Through 16 Weeks

Patients with dry eye disease who were treated with cyclosporine intracanalicular insert (OTX-CSI) saw improvements in their ocular surface health, according to research presented at the American Academy of Ophthalmology 2021 meeting, held in New Orleans, November 12-15. 

Patients with DED were recruited to this ongoing phase 1/2 trial and received either 0.36 mg OTX-CSI or vehicle. The trial was composed of 2 cohorts. Cohort 1 was run open-label (n=5), and cohort 2 (n=140) was conducted as a randomized, double-masked, vehicle-controlled study examining 2 formulations of OTX-CSI and vehicle. Over 16 weeks data were collected using Schirmer test (unanesthetized) corneal fluorescein staining (CFS; NEI scale), eye dryness score visual analogue scale (VAS; 0-100 scale) and adverse events (AE). 

In Cohort 1, no adverse events were reported and there was an improvement in the mean Schirmer test scores from baseline to week 16 (4.2 to 8.5 mm). One subject in this cohort achieved a greater than 10 mm increase (7 to 17 mm) by week 12. Week 12 also showed the greatest reduction in CFS from baseline (6.7 to 2.7). Additionally, average visual analogue scales, dryness severity, and frequency scores improved from baseline to week 16 (51 to 23 and 51 to 28, respectively). 

The presenters explained that the follow-up for cohort 2 is ongoing.

“Interim results showed OTX-CSI was generally safe and well tolerated, with no AEs observed,” according to the report. “Improvements in DED signs and symptoms started week 2 and were maintained to week 16.”

Reference

Christie WC, Segal BA, Shettle L, McClain N, Blender N, Goldstein MH. Phase 1/2 trial evaluating a novel, hydrogel-based cyclosporine intracanalicular insert in subjects with DED. Poster presented at: The American Academy of Ophthalmology 2021Annual Meeting; November 12-15, 2021; New Orleans. Abstract PO170.