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Introduction <p>This study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).</p> Methods <p>Twenty-four subjects diagnosed with cataracts and mild-to-moderate primary open-angle glaucoma were consented at a single site in Honduras. Those with pathologies that could confound outcomes were excluded. All subjects were required to have responded to topical prostaglandin analogues. Medication washout was performed prior to intervention. One eye of each subject was sequentially assigned to one of three arms (75&#xa0;μg, 150&#xa0;μg, or 300&#xa0;μg of bimatoprost pads). The product was delivered in-the-bag via a commercially available intraocular lens (IOL) inserter and did not modify the steps of standard phacoemulsification cataract surgery other than attachment of bimatoprost implants to the IOL. We report interim results through 36&#xa0;months.</p> Results <p>Twenty-one of 24 enrollees (87.5%) were retained through 36&#xa0;months. Through 24&#xa0;months, all subjects achieved the primary endpoint of intraocular pressure (IOP) reduction &gt; 20% from baseline without any additional glaucoma medications. By month&#xa0;36, all but a single subject (95.2%, <i>n</i> = 20) remained drop-free with continued IOP reductions &gt; 20% across all remaining subjects. Each treatment arm realized mean IOP reductions from 32.3% to 49.3% over 3&#xa0;years of follow-up visits. There were no significant intergroup differences. All eyes had a final best-corrected distance visual acuity of 20/30 or better. There were no serious implant-related adverse events. The most common events were dry eye (21.7%), transient vision decrease (13.0%), and subconjunctival hemorrhage (8.7%). All implants remained in the capsular bag.</p> Conclusions <p>The first human study of a novel system that mounts bimatoprost-infused pads to a single-piece IOL suggests favorable safety and efficacy and does not require additional surgical skills beyond routine cataract surgery. A larger sample with comparative data is necessary to further assess effects.</p> Trial Registration <p>ClinicalTrials.gov identifiers, NCT07154797 and NCT07154810. Retrospectively registered on September 3, 2025.</p>

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Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月1日

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  • Nicholas E. Tan,
  • Gregory Katz,
  • Marco Robles,
  • Preeya K. Gupta,
  • Malik Y. Kahook,
  • Glenn Sussman,
  • Paul Yoo,
  • Nathan M. Radcliffe

摘要

Introduction

This study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).

Methods

Twenty-four subjects diagnosed with cataracts and mild-to-moderate primary open-angle glaucoma were consented at a single site in Honduras. Those with pathologies that could confound outcomes were excluded. All subjects were required to have responded to topical prostaglandin analogues. Medication washout was performed prior to intervention. One eye of each subject was sequentially assigned to one of three arms (75 μg, 150 μg, or 300 μg of bimatoprost pads). The product was delivered in-the-bag via a commercially available intraocular lens (IOL) inserter and did not modify the steps of standard phacoemulsification cataract surgery other than attachment of bimatoprost implants to the IOL. We report interim results through 36 months.

Results

Twenty-one of 24 enrollees (87.5%) were retained through 36 months. Through 24 months, all subjects achieved the primary endpoint of intraocular pressure (IOP) reduction > 20% from baseline without any additional glaucoma medications. By month 36, all but a single subject (95.2%, n = 20) remained drop-free with continued IOP reductions > 20% across all remaining subjects. Each treatment arm realized mean IOP reductions from 32.3% to 49.3% over 3 years of follow-up visits. There were no significant intergroup differences. All eyes had a final best-corrected distance visual acuity of 20/30 or better. There were no serious implant-related adverse events. The most common events were dry eye (21.7%), transient vision decrease (13.0%), and subconjunctival hemorrhage (8.7%). All implants remained in the capsular bag.

Conclusions

The first human study of a novel system that mounts bimatoprost-infused pads to a single-piece IOL suggests favorable safety and efficacy and does not require additional surgical skills beyond routine cataract surgery. A larger sample with comparative data is necessary to further assess effects.

Trial Registration

ClinicalTrials.gov identifiers, NCT07154797 and NCT07154810. Retrospectively registered on September 3, 2025.