A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

A Prospective, Multicenter, Open Label Extension Study to Evaluate the Long Term Safety of OTX-TP

To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.

Inclusion Criteria:

• Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
• Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
• Have provided written informed consent, approved by the appropriate Institutional Review Board

Exclusion Criteria:

• Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
• Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
• Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
• Missed more than 2 visits during participation in the OTX-16-002 trial