Ocular Therapeutix is tailoring sustained release prostaglandin analogs for the treatment of glaucoma and ocular hypertension. Inserted non-invasively through the punctum, the sustained release depot resides within the canaliculus, delivering travoprost to the ocular surface for up to 90 days, to reduce or eliminate the need for daily dosing. The product also contains a visualization aid to monitor retention over the treatment period. After therapy is complete, the hydrogel resorbs and exits the nasolacrimal system.
In a recent clinical study (see figure below), Ocular Therapeutix demonstrated a robust IOP reduction and clinically significant results at three months with a single depot, demonstrating efficacy of the travoprost depots for the treatment of ocular hypertension and glaucoma. Results are comparable to topical brand name prostaglandin analog ophthalmic solutions.1 No serious adverse events occurred, including no increase in hyperemia, and patients were comfortable overall.
OTX-TP is in Phase 2 clinical development for glaucoma and ocular hypertension. Topline results were reported from a Phase 2b clinical trial for this indication in October 2015, and we expect to initiate a Phase 3 clinical trial of OTX-TP in the third quarter of 2016.
Sustained Release Travoprost Phase 2a Study Results
OTX-TP Comparison to Timolol and Placebo Plug
Mean 8:00 AM Reduction from Baseline
Average IOP reduction over three months with travoprost depot consistent with reduction observed with topical travoprost
Error bars = SEM
*Data on file, Ocular Therapeutix, Inc.
Glaucoma is a sight-threatening disease caused by elevated intraocular pressure. Over time, this elevated pressure leads to degeneration of cells which make up the optic nerve, slowly decreasing vision. Almost 2.3 million Americans age 40 and older have been diagnosed with the disease,2 with over 30 million glaucoma prescriptions in 2013.3 According to the World Health Organization, it is the second leading cause of blindness worldwide.4 It is a chronic condition which cannot be prevented or reversed, and therefore must be monitored for life.
Prostaglandin analog ophthalmic drops lower intraocular pressure, managing the progression of the disease. However, since glaucoma affects a primarily elderly population, many of those afflicted with the disease have difficulty complying with the required dosing regimen or being able to self-administer eye drops. In fact, it has been reported that <50% of glaucoma patients at 6 months administer ophthalmic drops as directed.5 Poor adherence to prescription regimens is of great concern to healthcare practitioners since consequences of non-compliance can lead to costly and invasive surgeries, vision impairment, or blindness. Prostaglandin analog intracanalicular depots may help manage the issues of non-compliance by vastly reducing dosing frequency.