A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension

The primary objective of this Phase 3b study is to evaluate the **duration** of the intraocular pressure (IOP)-lowering effect of **Bimatoprost SR** in participants with **Open-Angle Glaucoma** (OAG) or **Ocular Hypertension** (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy, such as intolerance or nonadherence. This is clinically relevant as it addresses the need for alternative treatment options in patients who cannot tolerate or adhere to standard topical therapies, potentially improving long-term management of these conditions.

Secondary objectives include evaluating the safety of Bimatoprost SR in the same patient population, ensuring that the treatment is not only effective but also safe for those who have difficulties with current topical medications.

The clinical trial involves a total of **348 participants** diagnosed with **Open-Angle Glaucoma** or **Ocular Hypertension**. The study population includes both male and female subjects, aged 18 years and older, who are not adequately managed with topical intraocular pressure (IOP)-lowering medications due to reasons other than medication efficacy, such as intolerance or nonadherence. Participants were selected based on their ability to be treated with specific eye drops as the sole therapy and their willingness to comply with study requirements, including withholding IOP treatments as necessary. The trial does not exclude based on gender, and both male and female participants are included. The study population is characterized by a range of health statuses, with specific criteria ensuring that participants have a central corneal endothelial cell density deemed acceptable by the investigator and a baseline best-corrected visual acuity of 20/50 or better in the study eye. Participants are required to provide written informed consent and must not be incarcerated or under legal protection measures. The trial also includes considerations for female participants to minimize pregnancy risk during the study period. The sponsor has not provided specific information regarding lifestyle considerations such as diet or physical activity.

The clinical trial is designed to evaluate the **duration of effect** of Bimatoprost SR in participants diagnosed with **open-angle glaucoma** or **ocular hypertension**. This is a Phase 3b, randomized, double-blind, controlled study. The trial aims to assess the intraocular pressure (IOP)-lowering effect of Bimatoprost SR in individuals who are not adequately managed with topical IOP-lowering medications due to reasons other than medication efficacy, such as intolerance or nonadherence. The study is expected to run from December 2019 to August 2025, with participant involvement lasting up to 36 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria, such as age, ability to be treated with certain eye drops, and acceptable central corneal endothelial cell density. Following the screening, a baseline visit will be conducted where participants must have been appropriately washed out of all IOP-lowering medications. During this visit, the IOP will be measured, and other baseline assessments will be performed. Subsequent follow-up visits will be scheduled to monitor the primary endpoint, which is the duration of the effect of Bimatoprost SR, and secondary endpoints, including adverse events, visual fields, and visual acuity assessments.

The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the long-term effects and safety of the treatment. Participants may be withdrawn from the study early if they experience significant adverse events, are unable to comply with the study protocol, or if the investigator deems it necessary for their safety. The study employs a single-use applicator for the intracameral administration of the Bimatoprost SR implant, ensuring precise delivery and minimizing contamination risks.

The clinical trial involves the use of **Bimatoprost SR**, an experimental medication designed for the treatment of **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 known for its intraocular pressure (IOP)-lowering effects. The maximum daily dose of Bimatoprost SR is 10 micrograms, with a total maximum dose of 20 micrograms over the treatment period. The treatment duration is set for a maximum of 36 months. The implant is delivered using a single-use applicator, which does not possess a CE mark. Participant compliance with the dosing schedule will be monitored throughout the study.

In addition to the experimental treatment, participants may receive standard-of-care therapy as deemed necessary by the clinical investigators. This may include the use of topical IOP-lowering medications, which participants have previously been unable to adhere to due to reasons other than medication efficacy, such as intolerance or nonadherence. The study does not include a placebo or comparator treatment, focusing solely on the evaluation of Bimatoprost SR's efficacy and safety profile. The trial aims to assess the duration of the IOP-lowering effect of Bimatoprost SR in the target population.

The efficacy of Bimatoprost SR in the clinical trial will be assessed primarily by evaluating the **duration of effect** of the implant in reducing intraocular pressure (IOP) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT). This primary endpoint will provide insight into how long the IOP-lowering effect of the treatment lasts in the target population.

Secondary endpoints will include a comprehensive assessment of various ocular parameters and potential adverse events. These will encompass visual fields, visual acuity, macroscopic bulbar conjunctival hyperemia, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments (including optic disc assessment), contact ultrasound pachymetry, gonioscopy, and specular microscopy. These assessments will help determine the broader impact of the treatment on ocular health and safety.

The trial will utilize a single-use applicator for the administration of the Bimatoprost SR implant via intracameral use. The study is designed to ensure that participants are adequately washed out of all IOP-lowering medications at the baseline visit, with IOP measurements taken at specific timepoints to monitor changes effectively. The trial will follow a structured schedule to collect and analyze data, ensuring that the efficacy of the treatment is thoroughly evaluated over the course of the study.