Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma

About the study

The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia. The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it. The study will also check: * how safely the implant is placed in and removed from the eye and how the body responds to the procedure, * how safe different doses of timolol are and how the body handles taking it, * the amount of Timolol released in the bloodstream, * if there is any positive effect on the pressure inside the eye.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Capable of giving signed informed consent.
In good general and mental health without ongoing clinically significant abnormalities in medical history.
Clinically proven diagnosis of primary open-angle glaucoma (POAG) in the previous 12 months.
Subjects with IOP not adequately controlled with the standard medication.
Pseudophakia, at least 12 months after surgery.

EXCLUSION CRITERIA

Exclusion Criteria:

Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6 inhibitors, or α2-agonists.
Subjects with a history of hypersensitivity or contraindications to β-blockers.
Significant risks caused by washout of ocular hypotensive medications.
History of any glaucoma not specified as POAG.
History of elevated IOP due to corticosteroid use.
History of ocular trauma.