OTX-TIC shows promise with interim phase 1 results
Subjects treated with OTX-TIC demonstrated a mean reduction in IOP from baseline of 7 mm Hg to 11 mm Hg as early as 2 days after administration, according to interim phase 1 clinical trial results presented by Ocular Therapeutix.
“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,” Michael Goldstein, MD, MBA, president, ophthalmology, and chief medical officer of Ocular Therapeutix, said in a press release. The company plans to present the study at the upcoming Glaucoma 360: New Horizons Forum.
OTX-TIC (travoprost intracameral implant) was evaluated in the prospective, multicenter, open-label trial in 19 patients with primary open-angle glaucoma or ocular hypertension across four cohorts. The implant formulation in cohorts 3 and 4 was designed for faster dissolution than the formulation in cohorts 1 and 2. Each patient received the implant in one eye while topical travoprost was used as an active comparator in the non-study eye.
Safety, biological activity, durability and tolerability were evaluated, as well as diurnal IOP at baseline, 2 weeks, 6 weeks, 12 weeks, 4 months and 6 months.
Durability of activity lasted for 6 months or longer with one implant in “many subjects” in the four cohorts, the release said. In cohorts 1 and 2, the implant biodegraded in 5 to 7 months, while it degraded in 3 to 5 months in cohorts 3 and 4.
No serious ocular adverse events occurred. Iritis was the most common adverse event.
“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,” Goldstein said in the release.