Ocular TherapeutixTM Reports on Topline Results of Phase 2b Glaucoma Clinical Trial
Clinically meaningful intraocular pressure reduction and improvement in depot retention demonstrated with OTX-TP at day 75
Timolol arm performed better than expected, performance may be improved by placebo plug
No hyperemia-related adverse events observed in any of the patients treated with OTX-TP
Conference call today at
In this trial, the duration of effect as measured by the clinically meaningful reduction of intraocular pressure (IOP) in the 4.5-5.7 mmHg range was observed out to 90 days with the sustained release OTX-TP drug product. This IOP lowering was comparable to levels seen in the treatment group with the same drug release rate in the Phase 2a clinical trial of OTX-TP. In the 2b trial, the patient group receiving timolol as a comparator drug in the presence of a placebo depot, achieved IOP lowering results that were higher than expected, based on results reported in the peer-reviewed literature. However, as previously reported, the trial was not powered to detect statistically significant differences in IOP lowering between patient groups.
There were no hyperemia-related adverse events noted in any of the patients treated with OTX-TP. Further, there have been no serious adverse events observed to date in the Phase 2b trial, and adverse events were generally similar in frequency across the treatment groups. A complete analysis of all safety data is pending study completion.
“We are pleased with the performance of OTX-TP as seen in the topline
results of our Phase 2b clinical trial for the treatment of glaucoma,”
The prospective, multicenter, randomized, double-masked, double dummy,
parallel-arm, active controlled study enrolled 73 patients at 11
clinical sites in
The timolol group was observed to have intraocular pressure lowering of 6.4-7.6 (with an average of 7.0) mmHg compared with baseline, and as noted, this was higher than expected, possibly due to enhanced residence time of the drug on the ocular surface due to occlusion of the punctum by the placebo vehicle depot. The average intraocular pressure lowering seen in four published studies using timolol was 6.2 mmHg. At day 60, which was the primary efficacy measure, the OTX-TP group had an IOP lowering effect of 4.8 mmHg, compared with IOP lowering of 6.4 mmHg for the timolol arm and at day 90, which was a secondary efficacy measure, the OTX-TP group had an IOP lowering effect of 5.2 mmHg, compared with an IOP lowering effect of 7.3 mmHg in the timolol arm.
The Phase 2b interim results are reported on all patients followed through a 90-day duration. Complete results on safety and efficacy through the end of the study are expected to be available in the first quarter of 2016.
Depots were found to be retained in 91% at day 60 and 88% of patients at day 75 when evaluating all patients completing the study through its 90-day duration. Retention was 48% at day 90, reflecting the corresponding absorption and clearance of the depots with the duration of drug release.
All patients were able to visualize the presence of the depots throughout the trial and ask for replacement depots if and when required. All but two OTX-TP treated patients were able to successfully receive a replacement product when their depots were lost any time prior to day 90.
Baseline (washout) evaluations for IOP were conducted at 4 weeks and 5 weeks following screening. It was seen that baseline IOP continued to drop by 1.0 mmHg for the OTX-TP group and 0.61 mmHg for the timolol group from week 4 to week 5, signaling the potential need for longer washout duration in future studies.
The Company plans to investigate in non-significant risk studies whether
the presence of the high-retaining placebo depots can be enhancing the
effect of timolol, as this has been reported in the literature. The
Company also plans to discuss potential clinical study designs with
About Glaucoma and Ocular Hypertension
Glaucoma and ocular hypertension are chronic, sight-threatening diseases
in which elevated levels of intraocular pressure are associated with
damage to the optic nerve, which may result in irreversible vision loss.
Glaucoma is the second leading cause of blindness in the world. Ocular
hypertension is characterized by elevated levels of intraocular pressure
without any optic nerve damage. Patients with ocular hypertension are at
high risk of developing glaucoma. In the U.S. alone 2.7 million people
suffer from glaucoma. According to IMS, there were 33 million
prescriptions and sales of over
About Sustained Release Travoprost
Sustained Release Travoprost (OTX-TP) is a preservative-free drug product candidate that resides within the canaliculus and delivers the prostaglandin analog travoprost to the ocular surface for up to 90 days. The drug release is designed to deliver a continuous steady release dose is sustained throughout the treatment period. A fluorescent visualization aid is formulated within the product to enable both the physician and the patient to monitor drug presence throughout the course of therapy.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 5:00 pm Eastern Time. The live webcast can be accessed by visiting the investor section of the Company’s website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620 (International) to listen to the conference call. The conference ID number for the live call will be 66607929. An archive of the webcast will be available until November 5, 2015 on the company’s website.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development of the Company’s product candidates, such as the ongoing
development and potential utility of OTX-TP for glaucoma and ocular
hypertension and the timing, design and conduct of potential Phase 3
clinical trials of OTX-TP, the Company’s plans for regulatory
submissions and the advancement of the Company's other product
candidates, the potential for the Company’s sustained release hydrogel
depot technology and other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend", "goal," "may", "might,"
"plan," "predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Ocular Therapeutix, Inc.
Vice President of Sales and Marketing