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

Age of participants: eligibility and baseline

Study	Quoted minimum age
SGP-005 phase 3	“22 Years”

“Mean age was 70.5 ± 9.6 years, with a near-equal gender ratio. All subjects were of Hispanic/Latino ethnicity and Caucasian race, and all were diagnosed with primary open-angle glaucoma (POAG) with a mean vertical cup-to-disc ratio of 0.6 ± 0.2.” (opens the source at this quote in a new tab)

“Patients with glaucoma and cataracts are primarily over the age of 65, making Medicare the primary payor.” (opens the source at this quote in a new tab)

Pregnancy and contraception: phase 3 eligibility

“Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception” (opens the source at this quote in a new tab)

Glaucoma subtypes excluded from phase 3

“Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma” (opens the source at this quote in a new tab)
“History of incisional glaucoma surgery or intraocular injections” (opens the source at this quote in a new tab)

Ocular comorbidities excluded from the first-in-human study

“Central corneal endothelial cell count < 2000 cells/mm2 by specular microscopy” (opens the source at this quote in a new tab)
“Diabetic retinopathy or diabetic maculopathy” (opens the source at this quote in a new tab)
“Any pathology of the zonules including evidence of zonular weakness, zonular instability, zonular damage, or coloboma effecting zonules” (opens the source at this quote in a new tab)

Pregnancy, lactation, pediatric, and geriatric use of bimatoprost: Lumigan labeling

“Because animal reproductive studies are not always predictive of human response LUMIGAN® 0.01% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.” (opens the source at this quote in a new tab)
“Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.” (opens the source at this quote in a new tab)
“No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.” (opens the source at this quote in a new tab)

Pregnancy, lactation, and pediatric use of intracameral bimatoprost: Durysta labeling

“There is no information regarding the presence of bimatoprost in human milk, the effects on the breastfed infants, or the effects on milk production.” (opens the source at this quote in a new tab)
“Safety and effectiveness of DURYSTA in pediatric patients have not been established.” (opens the source at this quote in a new tab)

Generalizability of first-in-human data to other populations

“The single-site design with a sample comprised entirely of white Latino patients with POAG further limits generalizability to wider populations.” (opens the source at this quote in a new tab)

Renal or hepatic impairment

No evidence found.