Clinical Report: Bimatoprost IOL Shows 12-Month IOP Reductions

Overview

Interim results from a randomized phase 1/2 trial presented at AAO 2026 found approximately 9 mmHg (about 35%) mean IOP reductions at 12 months with either dose of the investigational bimatoprost-eluting IOL system in patients undergoing cataract surgery. Most BIM-IOL recipients remained free of additional IOP-lowering medication, and reported adverse-event rates were similar across the two BIM-IOL groups and the topical timolol control group.

Background

Patients with mild-to-moderate open-angle glaucoma or ocular hypertension may undergo cataract surgery while also requiring IOP-lowering treatment. The BIM-IOL system is designed to be implanted in the capsular bag during standard phacoemulsification and to elute bimatoprost continuously for up to 3 years. The system was compared with a commercially available IOL plus twice-daily topical timolol in a phase 1/2 trial. It remains investigational and has not received FDA approval.

Data Highlights

Key Findings

• The prospective, multicenter, randomized, double-masked, controlled trial included 104 evaluable adults with mild-to-moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.
• At 12 months, the presentation characterized IOP reduction as approximately 9 mmHg, or about 35%, overall; time-matched reductions at 8 AM and 10 AM varied by dose and assessment.
• At 12 months, 98% of the 78-μg group and 96% of the 39-μg group remained free of additional IOP-lowering medication; all control participants remained free of additional medication while using assigned topical timolol.
• Adverse events were reported in 41% and 43% of the 78-μg and 39-μg groups, respectively, and 37% of controls. No serious adverse events, secondary surgical interventions, or explantations were reported.
• All eyes achieved best-corrected distance visual acuity of 20/32 or better; mean acuity across treatment groups was approximately 86 letters, equivalent to approximately 20/20.
• A 2024 report on a separate first-in-human study of 23 patients described a mean 44.6% IOP reduction at month 12 from preoperative washed-out baseline levels across three dose strengths; this is a distinct study from the AAO 2026 phase 1/2 trial.

Clinical Implications

The reported results describe IOP and safety outcomes for an investigational device used during cataract surgery; the system has not received FDA approval and is being evaluated in two pivotal phase 3 trials. The trial compared the device with topical timolol and reported medication use, visual acuity, and adverse events through 12 months.

Conclusion

In this phase 1/2 trial, the bimatoprost-eluting IOL was associated with approximately 35% mean IOP reduction at 12 months, with reported safety outcomes comparable across treatment arms. Longer-term and phase 3 findings are not provided in the source material.

Related Resources & Content

1. Ophthalmology Management, 2026 AAO — Bimatoprost IOL Shows 12-Month IOP Reductions
2. Conni Koury, Glaucoma Physician, 2024 — Data on IOL-based Delivery of Bimatoprost Presented at ASCRS
3. American Academy of Ophthalmology, 2026 — Primary Open-Angle Glaucoma Preferred Practice Pattern
4. Glaucoma Physician — Data on IOL-based Delivery of Bimatoprost Presented at ASCRS
5. Glaucoma Physician — SpyGlass Reports 12-Month Results for BIM-IOL System Recommendations
6. Bimatoprost IOL Shows 12-Month IOP Reductions
7. Data on IOL-based Delivery of Bimatoprost Presented at ASCRS
8. Primary Open-Angle Glaucoma Preferred Practice Pattern
9. DailyMed - DURYSTA- bimatoprost implant
10. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results | Ophthalmology and Therapy | Springer Nature Link