BEDFORD, Mass., Oct. 30, 2012 /PRNewswire/ -- Ocular Therapeutix, Inc. announced promising results of their sustained release travoprost (OTX-TP2) study for the treatment of glaucoma and ocular hypertension. OTX-TP2, a drug-eluting intracanalicular plug inserted through the punctum, was evaluated for the reduction of elevated intraocular pressure over a two-month period.
The pilot Phase II study enrolled twenty patients (36 eyes) at the Umhlanga Hospital Medical Centre and Netcare Alberlito Hospital in South Africa. Patients with documented open-angle glaucoma or ocular hypertension (intraocular pressure (IOP) >/= 24 mmHg and </= 34 mmHg) were enrolled in the study, with a mean IOP at baseline of 28.7 mmHg. A single plug was administered in each enrolled eye. Analysis showed a decrease in IOP of 6.8 mmHg over two months of treatment. No excessive tearing or other unanticipated adverse events occurred.
Time point | Mean IOP (mm Hg) | Reduction (mm Hg) |
Baseline | 28.7 | - |
Day 15 | 21.4 | 7.2 |
Day 30 | 22.1 | 6.6 |
Day 45 | 21.9 | 6.7 |
Day 60 | 21.8 | 6.8 |
Results are comparable to topical brand name ophthalmic solutions, Travatan® (Alcon Laboratories, Inc.), Lumigan® (Allergan, Inc.), and Xalatan® (Pfizer, Inc.).1 However, current topical administrations are plagued with issues of non-compliance, which can lead to costly and invasive surgeries, vision impairment, and even blindness. It has been reported that up to 60% of patients do not administer ophthalmic drops as directed, even though patients’ perception is that they are compliant with 97% of their dosing.2 Sustained release travoprost may help to circumvent these issues of patient non-compliance by eliminating the need for daily dosing.
“Not only did the plug deliver therapeutic amounts of drug over two months, reduction in intraocular pressure remained consistent and significant throughout the entire treatment period” stated Pierre Wassermann, Principal Investigator at the Umhlanga Hospital Medical Centre in South Africa. “This product has the potential to revolutionize management of the disease by putting drug dosing in the hands of the physician rather than the patient.”
Glaucoma is a chronic disease that must be monitored and treated for life, impacting more than 2 million Americans, and is the leading cause of blindness in the United States. “Achieving clinically meaningful IOP reduction over a two-month period with single-dose administration is a tremendous achievement” stated Amar Sawhney, President and CEO of Ocular Therapeutix, Inc. “We are optimistic about recent advances in extending delivery, visualization, and persistence of our formulations to longer durations.”
About Ocular Therapeutix’s Drug Products:
Ocular Therapeutix uses the company’s proprietary polyethylene glycol hydrogel intracanalicular plug technology to release proven and approved drugs in a sustained fashion over a specified period of time. At the end of the treatment period, the plug begins to absorb, and exits the nasolacrimal system without need for removal by the physician. The plugs contain a visualization agent for retention monitoring throughout the treatment period.
About Ocular Therapeutix, Inc.:
Founded in November 2006, Ocular Therapeutix, Inc. is a privately held company based in Bedford, MA, focused on the development and commercialization of ophthalmic therapeutic products using its proprietary hydrogel technology. Ocular Therapeutix is using its hydrogel technology for development of a variety of ophthalmic applications including hydrogel sealants for ocular surface protection, drug-eluting punctum plugs for treatment of various anterior segment diseases, and with therapeutic agents for back-of-the-eye diseases.
1Package Inserts: Xalatan® 0.005% latanoprost ophthalmic solution, Pfizer, Woodstock, IL, USA. 2011; Lumigan® 0.01% and 0.03% bimatoprost ophthalmic solution, Allergan, Irvine, CA, USA. 2012; Travatan Z® 0.004% travoprost ophthalmic solution, Alcon, Fort Worth, Texas, USA. 2010.
2Goldberg I. Compliance with Medical Management in Glaucoma. Asian J of Ophthalmol 2000;2(4):3-6.
SOURCE Ocular Therapeutix, Inc.
