The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.

This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.

Inclusion Criteria:

• Men and women aged ≥18 years
• Willing to participate and giving written informed consent
• Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
• Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma

Exclusion Criteria:

• History of allergic hypersensitivity or poor tolerance to latanoprost
• History of Substance abuse or addiction (alcohol drugs) in the past 3 years
• History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
• Any abnormality preventing IOP measurement

A total of 161 subjects enrolled in the study. Subjects received their first dose of the study drug at Visit 1 (Baseline Visit). A total of 149 subjects completed Study Visit 7 (End-of-Evaluations), which met FDA's recommendation of providing safety data for at least 100 subjects.

24 weeks

Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.