Ocular Therapeutix presented early phase 1 data on OTX-TIC, a travoprost intracameral implant for the treatment of patients with primary open-angle glaucoma (POAG) or ocular hypertension. The prospective, multicenter, open-label clinical trial is intended to evaluate the safety, biological activity, durability, and tolerability of OTX-TIC for the reduction of IOP.

In this phase 1 clinical trial, all 4 cohorts (total of 19 patients) experienced a mean reduction in IOP from baseline of 7-11 mmHg with onset of action as early as 2 days after insertion. Many subjects across the 4 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, which received a faster-dissolving implant. No meaningful changes in endothelial cell counts or pachymetry were observed across the cohorts.

“Compliance with topical drop therapy remains a clinical problem in the treatment of glaucoma and represents a large unmet medical need,” said Michael Goldstein, MD, MBA, chief medical officer, in a news release. “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. 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.”