Tavo Biotherapeutics
This study is evaluating a new eye drop containing pregabalin (TB0001) as a potential treatment for people with primary open-angle glaucoma or ocular hypertension. The study aims to determine whether TB0001 lowers eye pressure as effectively as timolol, a commonly used glaucoma eye drop, while remaining safe and well tolerated. Participants will be randomly assigned to receive one of three strengths of TB0001 or timolol for 28 days. Eye pressure, eye health, side effects and tolerability will be assessed throughout the study. The results will help identify the most appropriate dose of TB0001 for future clinical studies.
Inclusion Criteria: 1. Age more than or equal to 18 years. 2. Diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). 3. Participants with POAG must have mild to moderate disease, defined as a visual field defect score of less than 12 on the Advanced Glaucoma Intervention Study (AGIS) scale or a Humphrey Mean Deviation (MD)between 0 and -12 dB. 4. Intraocular Pressure (IOP) Criteria (study eye): 1. For participants currently receiving IOP-lowering therapy: * There must be documented evidence of a clinically meaningful reduction in IOP in response to currentl…
TB0001 is a sterile, clear colorless to slightly yellow pregabalin ophthalmic solution at concentrations of 0.9%
Pregabalin ophthalmic solution (TB0001) 1.2% is a sterile, colorless to slightly yellow solution.
TB0001 is a sterile, clear, colorless to slightly yellow solution
Timolol ophthalmic solution 0.5% will be administered twice daily (AM + PM)