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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 paired with timolol drops. Vision and safety results were similar across groups; follow-up is planned through three years, and two phase III trials have begun.
A bimatoprost-releasing intraocular lens reduced eye pressure by an amount noninferior to standard cataract surgery followed by timolol eye drops in a 104-patient randomized trial, according to results presented October 12 at the American Academy of Ophthalmology meeting. The 12-month findings suggest the lens could combine cataract treatment with glaucoma pressure management, but longer follow-up and phase III trials are still needed.
The phase I/II multicenter study enrolled people with both cataracts and glaucoma or ocular hypertension. Participants were assigned in a 2:1:1 ratio to one of two lens groups with different bimatoprost doses, or to a standard intraocular lens and timolol drops taken twice daily. The lens groups also used artificial tears twice a day. The primary measure was change in eye pressure at specified morning times.
At 12 months, average pressure at 8 a.m. had fallen by 8.85 mm Hg with the higher-dose lens, 11.36 mm Hg with the lower-dose lens, and 9.14 mm Hg in the drops comparison group. At 10 a.m., average reductions were about 8 to 9 mm Hg across all groups. The reported percentage reductions did not differ significantly, and both lens doses met the trial’s criteria for noninferiority against the control treatment at both measurement times.
Vision and medication use were also reported as broadly similar. All participants achieved at least 20/32 best-corrected distance vision; 75% in the higher-dose lens group, 65% in the lower-dose group, and 63% in the control group reached at least 20/20. At one year, no control-group participant and nearly all lens-group participants remained off additional glaucoma medication. Adverse events occurred at similar rates, with no serious events, secondary operations, or lens removals reported.
A Lens Could Reduce Daily Drop Dependence
Glaucoma treatment often depends on patients taking eye drops regularly over long periods. The study presenter, Jeffrey Kammer of Vanderbilt University Medical Center, said missed doses are a longstanding concern: he cited reported nonadherence rates of 30% to 50%, with some reports as high as 80%. The trial did not test whether the lens improves long-term adherence or prevents vision loss, but a drug-delivery approach built into cataract surgery could reduce reliance on daily glaucoma drops for some patients if later studies confirm the results.
The device may also offer an alternative to combining cataract surgery with minimally invasive glaucoma surgery. Kammer said the implanted lens is designed to release medication continuously and leaves the angle available for possible future surgery. Those are proposed advantages, not findings that establish better outcomes or wider suitability than existing options. The current results support further testing; they do not show that the lens should replace standard treatment.
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How the Bimatoprost Lens Works
The device, described as the BIM-IOL, carries two pads containing 39 micrograms of bimatoprost each. According to the presentation, the pads are designed to release the drug continuously for up to three years. Bimatoprost is used to lower intraocular pressure, a key treatment target in glaucoma. The trial compared this drug-delivery lens with a standard lens plus timolol drops, rather than with no treatment.
A first-in-human study reported the previous year followed 21 evaluable patients for three years. Kammer said their pressure fell by an average of 37%, one patient needed additional glaucoma medication, and all reached 20/30 vision; no product-related adverse events were reported. That small earlier study is separate from the randomized trial now reporting 12-month results and cannot by itself establish how well the device works across a broader patient population.
“The BIM-IOL system represents a new direction in drug delivery.”
— Jeffrey Kammer, Vanderbilt University Medical Center, speaking at the American Academy of Ophthalmology meeting
Long-Term Benefits Remain Unproven
The reported findings cover 12 months, while the device is designed to release medication for up to three years. The trial’s full three-year outcomes, including durability of pressure reduction and longer-term safety, have not yet been reported. The source report also does not provide detailed results for each adverse-event type or establish which patients are most likely to benefit.
The trial included people with open-angle glaucoma, who made up 85% of participants, and people with ocular hypertension. The results do not establish effectiveness for every form or severity of glaucoma. It is also not yet clear whether the lens will receive regulatory approval, how it would compare with other treatment choices in broader practice, or whether it would reduce the need for drops over the long term.
Phase III Studies Will Test Durability
Kammer said two phase III trials have begun. Their results should provide further evidence on pressure control, vision, safety, and the proportion of patients who need additional medication. Participants in the current phase I/II study are also expected to continue follow-up through three years, allowing researchers to assess outcomes beyond the first year.
Until those data are available, the finding is an early clinical result rather than proof of lasting benefit or a change in standard care. The next milestones are the larger trials’ reported outcomes and any subsequent regulatory decisions. The available report does not specify when those results or decisions are expected.
Key Questions
What did the trial find?
At 12 months, both bimatoprost lens groups met the study’s noninferiority criteria for reducing eye pressure compared with a standard lens plus timolol drops. The report says percentage reductions did not differ significantly between groups.
Who took part in the study?
The analysis included 104 randomized patients with cataracts and glaucoma or ocular hypertension. Open-angle glaucoma accounted for 85% of the study population.
Did participants still need glaucoma medication?
At 12 months, no patients in the control group needed additional glaucoma medication. The corresponding figures were 98.0% of the higher-dose lens group and 95.7% of the lower-dose group remaining free of additional medication.
Is the drug-releasing lens available as standard treatment?
The report describes trial results and says two phase III studies have begun. It does not report regulatory approval or a change to standard care, so availability and eventual use remain unclear.
What results are expected next?
Researchers will need to report longer-term follow-up and findings from the two phase III trials. Those data can help assess whether pressure reductions last, what risks emerge over time, and how often patients require additional treatment.
Source: rss
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