Evaluation of Long-term Safety and Efficacy of Bimatoprost SR Implant in Patients with Open-angle Glaucoma or Ocular Hypertension

The primary objective of this extension trial is to evaluate the long-term **safety** of **Bimatoprost SR** in patients diagnosed with **open-angle glaucoma** (OAG) or **ocular hypertension** (OHT). Additionally, the study aims to assess the duration of the intraocular pressure (IOP)-lowering effect of Bimatoprost SR in these patients. Understanding the safety profile and efficacy duration of Bimatoprost SR is clinically relevant as it may offer a sustained therapeutic option for managing elevated IOP, a critical factor in preventing optic nerve damage and vision loss in OAG and OHT patients.

The clinical trial involves a total of **410 participants** diagnosed with **open-angle glaucoma** or **ocular hypertension**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants were selected based on their completion of previous Bimatoprost SR Phase 3 studies or the open-label Phase 4 ARGOS study, ensuring no ongoing safety concerns. The trial includes individuals who are not part of a vulnerable population, and all participants have provided informed consent. Lifestyle factors such as diet and physical activity are not specified as part of the selection criteria. The study aims to evaluate the safety and efficacy of Bimatoprost SR in lowering intraocular pressure in the specified conditions.

The clinical trial is designed to evaluate the long-term safety and efficacy of **Bimatoprost SR** in patients with **open-angle glaucoma** or **ocular hypertension**. This is a Phase 5, randomized, double-blind, controlled trial. The trial aims to assess the safety of Bimatoprost SR and the duration of its intraocular pressure (IOP)-lowering effect. The trial is expected to conclude by April 19, 2025, with recruitment having started on November 14, 2019. Participants will be involved in the study for a maximum treatment period of 12 months, with the possibility of early termination if they do not adhere to study protocols or if safety concerns arise.

The sequence of study visits includes an initial screening visit to confirm eligibility based on specific inclusion criteria, such as the ability to provide informed consent and a negative pregnancy test for females of childbearing potential. Participants must have completed one of the previous Bimatoprost SR Phase 3 studies or the open-label Phase 4 ARGOS study without ongoing safety concerns. Follow-up visits will be scheduled to monitor safety and efficacy endpoints, including adverse events, visual field, visual acuity, and other ophthalmic assessments. The end-of-study visit will conclude the participant's involvement, ensuring all safety and efficacy data are collected.

Primary endpoints include the assessment of adverse events, visual field, visual acuity, and other ophthalmic evaluations. The key endpoint is the time from the last Bimatoprost SR treatment in the lead-in study to the first rescue treatment or first Bimatoprost SR PRN retreatment. Participants may be withdrawn from the study if they require non-study IOP-lowering medications or procedures, or if they fail to comply with study requirements. The trial employs a single-use applicator for intracameral use of the Bimatoprost SR implant, ensuring precise delivery of the active substance.

The clinical trial involves the use of **Bimatoprost SR**, an experimental medication designed to evaluate its long-term safety and efficacy in patients with **open-angle glaucoma** or **ocular hypertension**. **Bimatoprost SR** is formulated as an **implant** and is administered via **intracameral use**. The active substance in this medication is **bimatoprost**, a chemical compound. The maximum daily dose is 10 micrograms, with a total maximum dose of 10 micrograms over the treatment period. The treatment period is set for a maximum of 12 months. The implant is delivered using a single-use applicator, which does not have a CE mark. The product is manufactured by Allergan Sales LLC and is identified by the sponsor product code AGN-192024.

In this trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the administration of **Bimatoprost SR**. Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the treatment protocol. The trial aims to assess both the safety profile and the duration of the intraocular pressure-lowering effect of the implant in the target patient population.

The efficacy of Bimatoprost SR in patients with **Open Angle Glaucoma** (OAG) or **Ocular Hypertension** (OHT) will be assessed through a series of primary endpoints. These include adverse events (AEs), visual field assessments, visual acuity measurements, macroscopic conjunctival hyperemia evaluations, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments (including optic disc assessment), contact ultrasound pachymetry, gonioscopy for implant assessment, and specular microscopy. A key endpoint is the time from the last Bimatoprost SR treatment in the lead-in study to the first rescue treatment or first Bimatoprost SR PRN retreatment. Additional endpoints include the time from selective laser trabeculoplasty (SLT) treatment in the lead-in study to the first rescue treatment in the SLT-treated eye for patients from Study 192024-093 or -095.