Ocular Therapeutix Presents Interim Topline Data from the Phase 1 Clinical Trial of OTX-TIC in Patients With Glaucoma
Ocular Therapeutix announced plans to present data on OTX-TIC, a travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension, at the Glaucoma 360 New Horizons Forum being held virtually on January 30. As part of the event, Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix, has narrated a presentation on the OTX-TIC phase 1 study that is available today and can be accessed on the “Events and Presentations” section of the Ocular Therapeutix website.
The phase 1, prospective, multicenter, open-label, clinical trial is intended to evaluate safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of elevated IOP in patients with primary open angle glaucoma or ocular hypertension. Interim data presented at Glaucoma 360 are from the four fully enrolled cohorts (cohort 1=5 subjects, cohort 2=4 subjects, cohort 3=5 subjects, and cohort 4=5 subjects). Formulations of cohort 3 and 4 hydrogel implant include composition for faster dissolution when compared with cohorts 1 and 2.
In this phase 1 clinical trial, all cohorts experienced a mean reduction in IOP from baseline of 7-11 mm Hg with onset of action as early as two days after insertion. Many subjects across the four cohorts demonstrated durability of activity of 6 months or longer with a single implant. Overall, no serious ocular adverse events were noted. The hydrogel drug delivery system consistently biodegraded in 5-7 months in cohorts 1 and 2 and in 3-5 months in cohorts 3 and 4. No meaningful changes in endothelial cell counts or pachymetry were observed across the cohorts. Evaluation remains ongoing for cohort 4. As is typical for early stage clinical trials, this trial is not powered to measure efficacy endpoints with statistical significance.
“Compliance with topical drop therapy remains a clinical problem in the treatment of glaucoma and represents a large unmet medical need. OTX-TIC was developed to deliver travoprost for an extended duration of time and, if shown to be safe and effective, represents a possible solution to this problem. Continued long-term evaluation is ongoing but we are very excited by what we have seen with the early results from this trial,” Dr. Goldstein said in a company news release. “We continue to believe that OTX-TIC has the potential for a unique and differentiated drug product profile. Based on these data we continue to plan to initiate a phase 2 clinical trial in mid-2021.”
About OTX-TIC
OTX-TIC is designed to be a bioresorbable intracameral implant containing micronized travoprost that is injected into the anterior chamber of the eye and is intended for patients with glaucoma or ocular hypertension with a target duration of drug delivery of four months or longer. OTX-TIC is designed to directly address compliance issues by delivering travoprost over the course of several months with a single implant.