Abstract
Purpose :
Nonadherence to glaucoma drop therapy continues to be an issue in 30-80% of patients and can lead to fluctuations in intraocular pressure (IOP). There remains an unmet need for a therapy with a consistent and durable IOP lowering profile that improves patient compliance. OTX-TIC, an intracameral, bioresorbable, hydrogel-based implant, is designed to deliver travoprost at therapeutic levels in the anterior chamber and can potentially address issues with chronic drop therapy. This study evaluates the safety, tolerability and efficacy of OTX-TIC in subjects with glaucoma.
Methods :
Prospective, multicenter, open-label, Phase 1 study in adult subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT). After washout, subjects were enrolled into 4 cohorts (Cohort 1, 15μg; Cohort 2, 26μg; Cohort 3, fast-degrading hydrogel 15μg; Cohort 4, fast-degrading hydrogel 5μg) and received a single OTX-TIC implant (TIC) in the study eye and topical travoprost (Travatan Z; TZ) in the fellow eye. Diurnal IOP (8am, 10am, 4pm) was assessed at baseline, Days 14, 42, 85, and Months 4, 6, and 4-week follow-up after (8am only). Safety measures include adverse event (AE) collection, endothelial cell count (ECC), and pachymetry.
Results :
All cohorts have completed enrollment: Cohort 1 (n=5), Cohort 2 (n=4), Cohort 3 (n=5) and Cohort 4 (n=5). TIC lowered mean IOP levels up to 22, 9, 6 and 6 months in Cohorts 1, 2, 3, and 4, respectively. Eyes treated with TIC had a baseline mean IOP of 21-27 mmHg and all four cohorts showed IOP lowering of 7-11 mmHg which was comparable to TZ-treated eyes. Cohort 2 showed the most consistent and durable response with all subjects going to Month 6 without need for rescue medication in 50% of subjects to Month 9. TIC biodegraded consistently in 5-7 months for Cohorts 1 & 2 and 3-5 months for Cohorts 3 & 4. In all cohorts, no clinically meaningful changes in ECC or corneal thickness were observed. The most common AEs reported were low grade inflammation (all cohorts) and peripheral anterior synechiae (Cohort 1 only).
Conclusions :
OTX-TIC showed similar IOP control compared to topical travoprost therapy in subjects with POAG or OHT which was sustained for at least 6 months in many subjects. OTX-TIC was generally well tolerated with a favorable safety profile. Durability of IOP lowering effect was longest and most consistent in Cohort 2.
This is a 2021 ARVO Annual Meeting abstract.