Ocular Therapeutix: Q4 2015 Results (Ocular Therapeutix) - Mar 14, 2016 - “…meeting with the FDA in January of 2016…we have announced that our Phase 3 development program for OTX-TP in glaucoma and hypertension. The planned trial design for the two Phase 3 clinical trials includes an OTX-TP treatment arm and a placebo controlled comparator arm that would use a non-drug eluting intracanalicular depot. We do not expect our Timolol comparator, our validation arm will be required in the study design and do not expect that eye drops of placebo or active will be administered in either arm. We expect that the FDA will require the OTX-TP to show a statistically superior reduction of intraocular pressure compared to the placebo as a primary efficacy end point while also inducing a clinically meaningful IOP reduction…expect to initiate the first of the two planned Phase 3 clinical trials in the third quarter of 2016 after holding an end of Phase 2 meeting with the FDA in the second quarter of 2016.”
Anticipated FDA event • Anticipated new P3 trial • Eye Care
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Another objective of the Phase 2b trial was to assist in the design of our Phase 3 clinical trials. We had a meeting with the FDA in January of 2016 and following this meeting, we have announced that our Phase 3 development program for OTX-TP in glaucoma and hypertension. The planned trial design for the two Phase 3 clinical trials includes an OTX-TP treatment arm and a placebo controlled comparator arm that would use a non-drug eluting intracanalicular depot. We do not expect our Timolol comparator, our validation arm will be required in the study design and do not expect that eye drops of placebo or active will be administered in either arm.
We expect that the FDA will require the OTX-TP to show a statistically superior reduction of intraocular pressure compared to the placebo as a primary efficacy end point while also inducing a clinically meaningful IOP reduction. This is great news as we believe that a direct comparison of OTX-TP with a placebo comparator reflects the simplest and most real world appropriate clinical study design for this product. We expect to initiate the first of the two planned Phase 3 clinical trials in the third quarter of 2016 after holding an end of Phase 2 meeting with the FDA in the second quarter of 2016.
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