TL;DR
Get health and wellness essentials delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
A randomized phase I/II trial found that a bimatoprost-releasing intraocular lens reduced eye pressure over 12 months by a degree that met noninferiority criteria against a standard lens plus timolol drops. The study included 104 patients; follow-up is planned for three years, and two phase III trials have begun.
A bimatoprost-releasing intraocular lens met the trial’s criteria for noninferiority to a standard lens plus twice-daily timolol drops in reducing eye pressure among patients with cataracts and glaucoma or ocular hypertension, researchers reported October 12 at the American Academy of Ophthalmology meeting. The randomized phase I/II study tracked 104 patients for 12 months; follow-up is planned to continue for three years.
The trial compared two doses of the drug-eluting lens, called the BIM-IOL, with a standard intraocular lens and timolol drops. Patients receiving either BIM-IOL dose also used artificial tears twice daily. The study’s primary endpoint was the change in intraocular pressure (IOP) measured at matched times, 8 a.m. and 10 a.m.
At 8 a.m., average IOP fell by 8.85 mm Hg in the higher-dose group, 11.36 mm Hg in the lower-dose group and 9.14 mm Hg in the standard-lens-and-drops group. At 10 a.m., average decreases were about 8 to 9 mm Hg across all three groups. The percentage declines did not differ significantly between groups, and both BIM-IOL doses met the study’s noninferiority criteria compared with the control treatment.
The report said best-corrected distance vision was preserved across the groups. At least 20/32 vision was achieved by all participants; the share reaching 20/20 or better was 75% in the higher-dose lens group, 65% in the lower-dose group and 63% in the control group. No participant had a serious adverse event, required a secondary operation or had the lens removed. At 12 months, almost all patients remained free of additional glaucoma medication: all in the control group, 98% in the higher-dose group and 95.7% in the lower-dose group.
A Lens Could Reduce Reliance on Drops
The device is intended to combine cataract surgery and sustained glaucoma medication delivery in one procedure. Standard glaucoma drops require regular use, and the study presenter, Jeffrey Kammer of Vanderbilt University Medical Center, cited reported nonadherence rates of 30% to 50%, with some reports as high as 80%. Missed treatment can be associated with worsening glaucoma, though this trial did not establish that the lens improves long-term outcomes or adherence.
The results may matter to patients who already need cataract surgery and pressure-lowering treatment, because a lens that releases medication could reduce the need for daily drops. But the comparison establishes a 12-month pressure-lowering result against one drops-based regimen; it does not show that the device is superior to drops, prevents vision loss, or suits every patient. Longer follow-up and larger studies are needed to clarify its potential role.
Products Worth Considering
Therabody SmartGoggles 2nd Gen Heated Eye and Temple Massager
Philips Sonicare 5950 Rechargeable Electric Toothbrush with 2 Brush Heads, Pink
Withings BPM Connect Wi-Fi and Bluetooth Blood Pressure Monitor
As an affiliate, we earn on qualifying purchases.
How the Trial Was Designed
The study randomized patients in a 2:1:1 allocation to the higher-dose BIM-IOL, lower-dose BIM-IOL or standard intraocular lens plus timolol twice daily. Participants had a median age of 70. About 85% had open-angle glaucoma; the rest had ocular hypertension. Average starting pressure was 25.02 mm Hg at 8 a.m. and 24.60 mm Hg at 10 a.m.
Each BIM-IOL has two pads, each containing 39 micrograms of bimatoprost, designed to release the drug continuously over three years, according to the presentation. A 21-patient first-in-human study reported earlier showed average IOP reductions of 37% over three years, with one patient needing additional medication and no reported product-related adverse events. That earlier, smaller study is separate from the randomized results now reported.
Kammer said the lens is placed in the capsular bag and leaves the eye’s drainage angle available for possible future minimally invasive glaucoma surgery. He also argued that the approach may fit routine cataract surgery more readily than some surgical alternatives. Those points are the presenter’s assessment; the new trial did not compare the device directly with minimally invasive glaucoma surgery.
“The BIM-IOL system represents a new direction in drug delivery.”
— Jeffrey Kammer, MD, Vanderbilt University Medical Center
Long-Term Benefits Remain Unproven
The reported findings cover 12 months, while the planned follow-up is three years. The available report does not provide a detailed account of the dose quantities in each randomized lens arm, nor does it establish whether pressure control will remain stable over time or how outcomes may differ among specific patient groups.
The results show that the lens met a statistical noninferiority standard for the measured pressure changes; they do not establish superiority or prove that patients will avoid drops over the long term. The study also does not settle how the device compares with other glaucoma procedures, its longer-term safety, or how widely it may be suitable in routine care. Those questions require further trial data.
Phase III Trials Are Under Way
Kammer said two phase III trials have begun. The current randomized study is also expected to continue follow-up through three years. Those data should provide a longer view of pressure control, vision outcomes, medication use and adverse events than the 12-month results presented so far.
Until later results are available, the BIM-IOL remains a treatment under study. The report does not state when the phase III trials will finish or when regulators might review the device. Any decision about glaucoma treatment remains a matter for patients and their eye-care clinicians, based on individual circumstances and the options available.
Key Questions
What did the trial find?
At 12 months, both doses of the bimatoprost-releasing lens met noninferiority criteria against a standard lens plus timolol drops for reducing intraocular pressure at the study’s measurement times.
How many patients took part?
The analysis included 104 randomized patients with cataracts and glaucoma or ocular hypertension. Their median age was 70.
Did the lens eliminate the need for glaucoma medication?
Not for everyone. At 12 months, 98% of patients in the higher-dose lens group and 95.7% in the lower-dose group had not needed additional glaucoma medication. The trial does not establish longer-term medication use.
Was the lens shown to be safer or more effective than drops?
No. The reported pressure reductions met a noninferiority standard, rather than showing superior effectiveness. Adverse events occurred at similar rates across groups, and no serious adverse events were reported during the 12-month results.
What happens next?
Two phase III trials have begun, and the current study is expected to follow patients for three years. The report did not give completion dates or a regulatory timeline.
Source: rss
