Abstract
Purpose :
OTX-TIC (travoprost intracameral implant) is a resorbable hydrogel-based implant delivering travoprost intracamerally in a sustained-release fashion in the anterior chamber. Here we evaluate the safety, tolerability and efficacy of a single OTX-TIC implant, in subjects with primary open-angle glaucoma or ocular hypertension in a Phase 1 study.
Methods :
Prospective, multicenter open-label Phase 1 trial is ongoing. Diurnal intraocular pressure (IOP) (8am, 10am, 4pm) is measured at Baseline, Days 14, 42, 85, Months 4, 6 and 4-week follow-up after (8am only). Study eye received intracameral placement of OTX-TIC. Non-study eye was treated with topical travoprost (Travatan Z). Safety evaluations include: adverse event collection, slit lamp biomicroscopy, gonioscopy, endothelial cell count with specular microscopy, pachymetry, optical coherence tomography (OCT) imaging, and visual field tests. Implant is visualized at every visit. Three cohorts: low dose(n=5), high dose (n=4) and fast-degrading low dose (n=3; enrolling) are being evaluated.
Results :
Mean IOP change from baseline were decreased as early as two days following implantation measured, with differences up to 7-10 mmHg recorded in the low (up to 15 months) and high dose (up to 6 months) cohorts. No differences in IOP control compared to non-study eye were noted. No differences in mean IOP change from baseline noted between low and high dose cohorts (both fully enrolled) at 6 months. No changes in endothelial cell counts or corneal thickness noted. Most common adverse events reported include low grade inflammation and peripheral anterior synechiae. Implant generally degrades in 5-7 months. No implant movement noted.
Conclusions :
OTX-TIC IOP lowering similar to topical prostaglandin drop. Implant has generally been well tolerated with a favorable safety profile. It has remained localized to site of insertion. Implant resorbs in 5-7 months (low and high dose cohorts) with consistent IOP-lowering effect with a single insert observed for over a year in at least one patient.
This is a 2020 ARVO Annual Meeting abstract.