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A randomized phase I/II trial found that a bimatoprost-releasing intraocular lens lowered eye pressure over 12 months by an amount noninferior to a standard lens combined with timolol drops. Vision and safety outcomes were similar across the groups; follow-up is planned for three years, and two phase III trials have begun.
A bimatoprost-releasing intraocular lens lowered eye pressure by an amount noninferior to a standard lens plus timolol drops in a randomized trial of people with cataracts and glaucoma, researchers reported at the American Academy of Ophthalmology meeting in New Orleans. The 12-month results also showed similar vision and safety outcomes across the three study groups; longer follow-up is continuing.
The phase I/II multicenter trial included 104 patients, with a median age of 70. Participants were assigned in a 2:1:1 ratio to one of two lens groups, each with a different bimatoprost dose, or to a standard intraocular lens and timolol eye drops twice daily. Patients in the lens groups also used artificial tears twice daily. Most participants, 85%, had open-angle glaucoma; the others had ocular hypertension.
At 8 a.m., average intraocular pressure fell by 8.85 mm Hg in the higher-dose lens group, 11.36 mm Hg in the lower-dose group and 9.14 mm Hg in the standard-lens-plus-timolol group. At 10 a.m., the average decrease was between 8 and 9 mm Hg in each group. The percentage reductions did not differ significantly, and the reported reductions met the trial’s noninferiority criteria for both lens doses compared with the control treatment.
Vision was preserved across all groups: every patient reached at least 20/32 best-corrected distance vision. At 12 months, additional glaucoma medication had not been needed by any control patients, 98% of those with the higher-dose lens and 95.7% of those with the lower-dose lens. Adverse events occurred at similar rates, and the report said no patient had a serious adverse event, required another operation or had the lens removed.
A Lens Could Reduce Reliance on Drops
The findings point to a possible way to combine cataract vision correction and pressure-lowering treatment in one operation. Glaucoma eye drops generally require regular administration, while this lens is designed to release medication gradually after implantation. A device that maintains pressure control without daily glaucoma drops could be relevant to patients who have difficulty following a drop schedule, though this trial does not yet establish long-term benefit or prove that patients can routinely stop other treatment.
Presenting the results, Jeffrey Kammer of Vanderbilt University Medical Center said the lens system “combines visual rehabilitation and IOP management in a single surgical intervention.” He also said its placement in the capsular bag is not expected to create additional risk to corneal endothelial cells and that it preserves the eye’s angle for possible future minimally invasive glaucoma surgery. Those comments describe the device’s proposed advantages; the current report covers clinical results through 12 months, not definitive evidence of long-term performance.
The trial’s comparison is clinically relevant because it tested the lens against a standard cataract lens plus an active glaucoma medication, rather than against no pressure-lowering treatment. Still, the study was relatively small, and the reported results should be understood as early clinical evidence, not as proof that the lens is suitable for every patient with both conditions.
bimatoprost releasing intraocular lens
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How the Drug-Releasing Lens Works
The BIM-IOL holds two pads containing 39 micrograms of bimatoprost each, designed to release the medicine continuously over three years, according to the presentation. Bimatoprost is used to lower intraocular pressure. The trial tested two dose versions of the drug-releasing lens against a standard intraocular lens with timolol drops twice daily.
Kammer described daily drop use as a challenge in glaucoma care and cited reported nonadherence rates of 30% to 50%, with some reports as high as 80%. Those figures were presented as background to the device’s rationale, not as an outcome measured in this trial. A prior first-in-human study, also described in the report, followed 21 evaluable patients for three years and found an average 37% pressure reduction; that earlier small study is separate from the current randomized comparison.
“The BIM-IOL system represents a new direction in drug delivery.”
— Jeffrey Kammer, MD, Vanderbilt University Medical Center, speaking at the American Academy of Ophthalmology meeting
glaucoma pressure-lowering intraocular lens
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Long-Term Outcomes Are Pending
The reported comparison covers 12 months, while the lens is designed to release medication for three years. The report does not establish whether pressure reduction will remain comparable over the full follow-up period, how often patients may eventually need additional glaucoma treatment, or whether less common or later adverse effects will emerge. It also does not provide enough detail to determine how results may vary among patient subgroups or how the device performs against other glaucoma procedures.
The presentation reported similar safety profiles and no serious adverse events in the study groups, but a trial of 104 patients cannot settle every question about uncommon risks. The findings were presented at a medical meeting; the supplied report does not state whether the results have been published in a peer-reviewed journal or provide full statistical details of the analysis.
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Phase III Trials Will Extend Testing
Kammer said two phase III trials have begun. These larger studies are expected to add evidence about the lens’s pressure-lowering performance and safety. Participants in the current trial are also scheduled for follow-up through three years, allowing researchers to track longer-term outcomes, including whether patients need additional medication or further procedures. The available report does not specify the phase III trials’ enrollment targets, completion dates or when results are expected.
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Key Questions
What did the trial find?
At 12 months, both doses of the bimatoprost-releasing lens met the study’s noninferiority criteria for lowering intraocular pressure compared with a standard lens plus timolol drops. The report also described similar vision and safety outcomes among the groups.
Does the lens mean patients no longer need glaucoma drops?
Not necessarily. At 12 months, most patients in the lens groups had not needed additional glaucoma medication, but some did. The trial does not show that every patient can stop drops or other glaucoma treatment.
How long is the lens designed to release medication?
The lens has two bimatoprost-containing pads designed to release the medicine continuously over three years. The results reported so far cover 12 months, so longer-term performance remains under study.
When will more results be available?
Two phase III trials have begun, and follow-up in the current study is planned to continue for three years. The report did not give a schedule for when either set of longer-term results will be released.
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