Name: BIM-IOL System in Open-angle glaucoma or ocular hypertension: Pharmacodynamics
Published: 2026-09-17T18:17:42-04:00

Product information and disease description Product description Product information Pharmacology

Pharmacodynamics

5 evidence topics · 3 sources

Onset and time to maximum IOP effect of topical bimatoprost: Lumigan labeling

“Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours.” (opens the source at this quote in a new tab)

Onset and durability of IOP lowering: first-in-human study

“By week 1, all groups achieved mean IOP reductions exceeding 40% (p < 0.05 all). This extent of IOP control generally held stable across 2 years of follow-up, with a small uptick in IOP in the medium configuration (150 μg) cohort at year 3 (Fig. 3).” (opens the source at this quote in a new tab)
“For the aggregate sample, mean percentage IOP reduction from baseline was 36.7 ± 9.4% (p < 0.0001) by month 36.” (opens the source at this quote in a new tab)

Dose response: first-in-human study

“Outcomes were not significantly different between low, medium, and high concentrations of sustained release bimatoprost. One may hypothesize that higher doses would correlate with more substantive IOP-lowering. However, this did not necessarily hold true in the current sample; the greatest IOP reduction from baseline to month 36 was achieved in the 75 μg cohort.” (opens the source at this quote in a new tab)

Dose response: phase 1/2 trial at 3 and 12 months

“At three months, we observed mean IOP reductions of -9.29 mmHg (8 a.m.) and -9.19 mmHg (10 a.m.) for the 78 mcg dose group, -9.64 mmHg (8 a.m.) and -8.70 mmHg (10 a.m.) for the 39 mcg dose group, and -9.63 mmHg (8 a.m.) and -10.24 mmHg (10 a.m.) for the control group.” (opens the source at this quote in a new tab)
“Evaluable patients in the 78-mcg (N=47) and 39-mcg (N=21) dose groups achieved a 34% and 42% reduction in mean IOP from baseline, respectively, compared to a 35% reduction in the control (N=29) group at 8 a.m. Results were similar at the 10 a.m. timepoint.” (opens the source at this quote in a new tab)

Nonclinical toxicology: 39-week single-dose rabbit study

“Under the conditions of the pivotal, 39-week, single-dose toxicity study, the no observed adverse effect level (NOAEL) for bimatoprost was determined to be 300 mcg/eye/dose (1000 ng/eye/day in vitro), which was also the highest dose tested.” (opens the source at this quote in a new tab)
“The inflammatory response was comparable across the groups in each study, and for the 39-week study, was comparable to the standard commercial IOL control group. Importantly, no bimatoprost-related ophthalmic or microscopic observations were noted.” (opens the source at this quote in a new tab)