Objective:

Assess the safety and initial IOP-lowering efficacy of two doses of an investigational bimatoprost-eluting intraocular lens (BIM-IOL) compared with a standard IOL plus topical timolol in adults with mild-to-moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

Approach:

• Design: Prospective, multicenter, randomized, double-masked, controlled phase 1/2 trial with 104 evaluable participants.
• Groups: Participants received a BIM-IOL containing 78 μg (n=51) or 39 μg (n=23) of bimatoprost, or a commercially available IOL plus twice-daily timolol 0.5% (n=30).
• Assessments: IOP, visual outcomes, and safety were assessed; the reported 12-month efficacy analysis included 48, 22, and 30 participants in the respective groups.

Key Findings:

• At 12 months, the presentation reported approximately 9 mmHg, or 35%, mean IOP reduction overall; reductions were described as comparable to topical timolol.
• At 12 months, 98% of the 78-μg group and 96% of the 39-μg group remained free of additional IOP-lowering medication. Control participants remained free of additional medication while using assigned timolol.
• Adverse events occurred in 41% of the 78-μg group, 43% of the 39-μg group, 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 groups was approximately 20/20.

Interpretation:

The interim phase 1/2 findings showed IOP reductions and safety outcomes described as comparable between the BIM-IOL groups and the timolol control through 12 months. The system remains investigational and has not received FDA approval.

Limitations:

• The 12-month analysis was interim; longer follow-up is needed to assess durability of IOP control and safety.
• The operating surgeon could not be fully masked, although IOP measurements remained masked.
• Participants had ocular hypertension or mild-to-moderate open-angle glaucoma, so applicability to more advanced disease is undetermined.
• Participants entered on 0 to 3 IOP-lowering medications and underwent varying washout periods.