In the Phase 1 clinical trial, OTX-TIC reduced intraocular pressure (IOP) in primary open angle glaucoma or ocular hypertension patients
Ocular Therapeutix, a provider of therapies for eye diseases, has unveiled data from the clinical trial of its OTX-TIC, for the treatment of primary open angle glaucoma or ocular hypertension.
Glaucoma is a progressive disease characterised by increased levels of IOP, and is associated with damage to the optic nerve, which may lead to irreversible vision loss.
The biopharmaceutical firm said that the single insertion of OTX-TIC in the Phase 1 clinical trial showed reduction in intraocular pressure (IOP), in primary open angle glaucoma or ocular hypertension patients.
Ocular Therapeutix chief medical officer Michael Goldstein said: “While glaucoma is a complex disease, lowering intraocular pressure remains a key target to prevent damage to the optic nerve. 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.”
OTX-TIC implant to address issues in delivering travoprost for glaucoma
Ocular Therapeutix has designed its OTX-TIC as a bioresorbable intracameral implant containing micronized travoprost, which is injected into the anterior chamber of the eye, for glaucoma patients.
The implant showed an acceptable safety profile, maintenance of drug levels in the aqueous humor and a sustained drop of intraocular pressure, in the preclinical studies conducted on beagles.
The company said that the Phase 1, open-label, multi-centre, dose escalation clinical study is aimed at evaluating the safety, efficacy, durability, and tolerability of OTX-TIC for the reduction of intraocular pressure in patients with primary open angle glaucoma or ocular hypertension.
Data from the clinical trial showed a decrease in mean IOP values and a continued decrease of the mean IOP values from the baseline values through the study.
The study results showed OTX-TIC was generally safe and well tolerated, with no reported serious adverse events, and changes in corneal health as measured by corneal pachymetry and endothelial cell count evaluation. The implant will be biodegraded in a period of approximately five to seven months.
Goldstein added: “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.”
Ocular Therapeutix is a biopharmaceutical company focused on the formulation, development, and marketing of advanced therapies for diseases and conditions of the eye. The company intends to present the study data at the Glaucoma 360 conference in San Francisco.