— BIM-IOL system noninferior to standard IOL plus eye drops for reducing intraocular pressure
October 12, 2026 • 4 min read
NEW ORLEANS -- An intraocular lens (IOL) packed with glaucoma medication showed early promise as a potential treatment for cataract and glaucoma in randomized comparison against standard glaucoma therapy.
The bimatoprost drug pad-intraocular lens (BIM-IOL) with either of two doses of glaucoma medication reduced intraocular pressure (IOP) to a similar degree as a standard IOL plus timolol eye drops. During 12 months of follow-up, IOP as measured at 8 a.m. had declined by an average of 8.85 mm Hg with the higher dose of bimatoprost, 11.36 mm Hg with the lower dose, and 9.14 mm Hg with the timolol eye drops. Follow-up measurement at 10 a.m. showed average decreases of 8-9 mm Hg in all three groups. The percentage decline in IOP did not differ significantly at either measurement time.
Best-corrected distance visual acuity (BCDVA) was preserved in all three groups, almost no patients required additional glaucoma medication, and safety profiles were similar in the three groups, reported Jeffrey Kammer, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, at the American Academy of Ophthalmologyopens in a new tab or window meeting.
"The BIM-IOL system represents a new direction in drug delivery," said Kammer. "The IOL drug delivery system combines visual rehabilitation and IOP management in a single surgical intervention that maintains the expected monofocal performance with clinically meaningful intraocular pressure reduction. Since the device is implanted in a capsular bag, it's not expected to introduce any additional endothelial cell risk, and that has been found to be true. It also preserves the angle for future MIGS [minimally invasive glaucoma surgery], if necessary."
Calling the results "pretty interesting," a member of the audience identified as a consultant to the pharma industry asked about the relative amount of medication in the BIM-IOL as compared with standard eye drop therapy.
The lens carries two pads, each containing 39 µg of bimatoprost, designed to be released continuously over 3 years.
"Let's just say it's much more efficient than the drops, giving it intraocularly," said Kammer.
The BIM-IOL design addresses two limitations of current glaucoma treatment options. Eye drops require lifelong daily administration, and adherence has been a historical issue, with reported nonadherence rates of 30-50% and ranging as high as 80%, said Kammer. Nonadherence has been associated with deterioration of glaucoma status.
MIGS also offers the potential to address cataract and glaucoma in a single procedure, combining IOL insertion with implantation of a small drainage device, Kammer continued. However, the ophthalmology community has been slow to embrace the technology.
"We know that the adoption rate [for MIGS] is only about 40%," said Kammer. "That's because physicians have issues with angle anatomy, have issues with the side-effect profile, have issues with additional time. I think this procedure [BIM-IOL] fits seamlessly into traditional or routine cataract surgery, and I think the adoption rate should be much higher."
Results of a first-in-human trial of the system were reported last yearopens in a new tab or window. The 21 evaluable patients had reductions in IOP averaging 37%, only one patient required additional glaucoma medication during 3 years of follow-up, and all of the patients achieved BCDVA of 20/30. No product-related adverse events were reported.
Kammer reported 12-month results from a phase I/II multicenter randomized trial involving patients with both coexisting cataract and glaucoma. They were randomized (2:1:1) to two BIM-IOL arms with different amounts of bimatoprost (plus artificial tears administered twice daily) or to a standard IOL plus timolol drops twice a day. The primary endpoint was time-matched IOP (8 a.m. and 10 a.m.) reduction. Follow-up will continue for 3 years.
Data analysis included 104 randomized patients who had a median age of 70. Open-angle glaucoma accounted for 85% of the study population, and the remaining patients had ocular hypertension. Mean IOP at baseline was 25.02 mm Hg at 8 a.m. and 24.60 mm Hg at 10 a.m.
After 12 months, the mean decline in IOP at 8 a.m. and 10 a.m. met criteria for noninferiority in both BIM-IOL groups versus control. The range in percentage decline across the three groups was 34.44-42.16% at 8 a.m. and 33.30-39.93% at 10 a.m.
All of the patients in the control group remained free of additional medication at 12 months, as did 98.0% of the BIM-IOL group that received the higher-dose IOL and 95.7% of the lower-dose cohort.
Three fourths of patients in the higher-dose BIM-IOL group had at least 20/20 BCDVA, as did 65% of the lower-dose BIM-IOL group and 63% of the control group. All of the patients achieved at least 20/32 vision.
Adverse events (AEs) occurred in a similar proportion of patients in all three groups, and no patients had a serious AE or required secondary surgical interventions or explantation.
Kammer said two phase III trials of the device have begun.