Product information and disease description Product description Product information

Contraindications/Warnings/Precautions/Adverse effects

6 evidence topics · 4 sources

Warnings and precautions

FDA-approved prescribing information for the BIM-IOL System

Not applicable.

Ocular adverse events: phase 1/2 trial at 3 and 12 months

“Only one patient receiving the BIM-IOL System reported allergic conjunctivitis (1/50, 2.0%) and there were no other reports of conjunctival hyperemia. Similar AE rates were observed in the 78 mcg (35.3%), 39 mcg (39.1%) and the control (33.3%) groups.” (opens the source at this quote in a new tab)
“AE rates were similar across the 78-mcg (41.2%), 39-mcg (43.5%), and control (36.7%) groups. No serious ocular AEs were observed.” (opens the source at this quote in a new tab)

Adverse event through three months	78 mcg (n = 51)	39 mcg (n = 23)	Control (n = 30)
Iritis	“4 (7.8)”	“1 (4.3)”	“1 (3.3)”
Corneal edema	“3 (5.9)”	“2 (8.7)”	“1 (3.3)”
Eye inflammation	“3 (5.9)”	“0”	“0”
Visual impairment (i.e., halos)	“2 (3.9)”	“0”	“0”
Dry eye	“0”	“4 (17.4)”	“1 (3.3)”
Visual acuity reduced (BCDVA loss ≥ 10 letters)	“2 (3.9)”	“2 (8.7)”	“2 (6.7)”
Meibomian gland dysfunction	“4 (7.8)”	“0”	“2 (6.7)”

Corneal endothelial cell loss: phase 1/2 trial

“Endothelial cell density loss was within the expected range for post-cataract surgery glaucoma patients, with patients receiving the BIM-IOL System demonstrating an average loss of 14.9% compared to 12.1% in the control group. Importantly, endothelial cell density levels remained stable between three and six months.” (opens the source at this quote in a new tab)

Adverse events and implant stability through 36 months: first-in-human study

“There were no serious implant-related adverse events. The most common events were dry eye (21.7%), transient vision decrease (13.0%), and subconjunctival hemorrhage (8.7%). All implants remained in the capsular bag.” (opens the source at this quote in a new tab)
“There were no cases of prostaglandin-associated periorbitopathy, no abnormal eyelash growth, and no cases of iris hyperpigmentation. There were no IOL dislocations, bimatoprost drug pad displacements, explantations, or reports of clinically significant posterior capsule opacification.” (opens the source at this quote in a new tab)
“There was a reduction from a baseline of 2308 ± 223 cells/mm2 to 2068 ± 374 cells/mm2 (− 10.4%) by month 6 and 2013 ± 407 cells/mm2 (− 12.8%) by month 12.” (opens the source at this quote in a new tab)

Warnings and precautions for topical bimatoprost: Lumigan labeling

“Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. (5.1)” (opens the source at this quote in a new tab)
“Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis).” (opens the source at this quote in a new tab)
“Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. LUMIGAN® 0.01% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.” (opens the source at this quote in a new tab)

Contraindications and warnings for intracameral bimatoprost: Durysta labeling

“DURYSTA is contraindicated in patients whose posterior lens capsule is absent or ruptured, due to the risk of implant migration into the posterior segment.” (opens the source at this quote in a new tab)
“The presence of DURYSTA implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration of DURYSTA should be limited to a single implant per eye without retreatment.” (opens the source at this quote in a new tab)
“Intraocular surgical procedures and injections, including DURYSTA, have been associated with endophthalmitis.” (opens the source at this quote in a new tab)

Sponsor-disclosed risk: future identification of bimatoprost adverse effects

“In addition, although bimatoprost has been commercially available for several years, regulatory authorities may identify adverse side effects related to bimatoprost in the future.” (opens the source at this quote in a new tab)

Procedures for implant removal or exchange

No evidence found.