Ocular Therapeutix presented data on OTX-TIC, a long acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension. Data from this phase 1 clinical trial demonstrated a clinically-meaningful reduction in IOP for up to 18 months in these patients treated with a single insertion of OTX-TIC. The presentation also included positive safety and tolerability data in both cohorts enrolled to date. These data will be presented at the Glaucoma 360 conference in San Francisco by the company’s chief medical officer, Michael Goldstein, MD, MBA.
“While glaucoma is a complex disease, lowering intraocular pressure remains a key target to prevent damage to the optic nerve,” Dr. Goldstein said in a company news release. “There are many topical eye drop options on the market to treat IOP associated with glaucoma, but poor compliance rates are very high. By delivering the therapy through a single intracameral implant, we have the ability to ensure that patients are receiving the appropriate amount of therapy needed to lower IOP on an ongoing basis. While the number of patients treated so far is small, these data seem to show that not only has OTX-TIC lowered IOP levels quickly, but also decreased IOP levels for as long as up to 18 months. We are very excited by what we have seen with the early results from this trial and look forward to continuing enrollment and further evaluation of these patients over time.”
The phase 1, prospective, multcenter, open-label, dose escalation clinical trial is intended to evaluate the safety, efficacy, durability, and tolerability of OTX-TIC for the reduction of elevated IOP in patients with primary open angle glaucoma or ocular hypertension. Data from the first two fully enrolled cohorts (cohort 1=5 subjects, cohort 2=4 subjects) show decreased mean IOP values in patients receiving OTX-TIC. The data also show that the mean IOP values remained decreased from the baseline values through the study period and beyond and, in one patient, for eighteen months at the time of assessment.
Overall, OTX-TIC was generally safe and well tolerated and no serious adverse events were reported. No changes in corneal health were noted as measured by corneal pachymetry and endothelial cell count evaluation. The implant biodegraded consistently in approximately 5-7 months. Enrollment has begun in the third and fourth cohorts of the trial while continued long-term evaluation remains ongoing in the first two cohorts. As is typical for Phase 1 trials, this Phase 1 clinical trial is not powered to measure any efficacy endpoints with statistical significance.
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 with a target duration of drug delivery of 4 to 6 months. Preclinical studies in beagles have demonstrated an acceptable safety profile, maintenance of drug levels in the aqueous humor and a sustained lowering of intraocular pressure. OTX-TIC is designed to directly address compliance issues by delivering travoprost over the course of several months with a single implant.