Article

Ocular Therapeutix: Positive Data on Long-Term Implant

Related

■ Ocular Therapeutix has presented positive phase 1 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 clinical trial demonstrated a clinically meaningful reduction in IOP for up to 18 months in patients treated with a single insertion of OTX-TIC. The news release also included positive safety and tolerability data in both cohorts enrolled to date.

“There are many topical eyedrop options on the market to treat IOP associated with glaucoma, but poor compliance rates are very high,” said Michael Goldstein, MD, MA, company CEO. “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.”

Data from the first 2 fully enrolled cohorts (cohort 1 with 5 subjects; cohort 2 with 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 1 patient, for 18 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 to 7 months. Enrollment has begun in cohorts 3 and 4 of the trial, while continued long-term evaluation remains ongoing in the first 2 cohorts.