Additional Relevant Details
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 hydrogel-based intracanalicular depot. The Company does not expect that a timolol comparator or validation arm will be required in the study design and does not expect that eye drops, placebo or active, will be administered in either arm. The Company expects that the FDA will require that OTX-TP show a statistically superior and clinically meaningful reduction of intraocular pressure (IOP), compared to the placebo, as a primary efficacy endpoint.