Summary

No head-to-head clinical comparison of the BIM-IOL System with Durysta, iDose TR, topical bimatoprost, SLT, or MIGS has been reported. The phase 3 comparator is a commercial monofocal IOL plus twice-daily timolol 0.5%, the same active control used in the registrational trials of Durysta and iDose TR. Product characteristics differ by labeling and sponsor disclosures: Durysta is a biodegradable 10 mcg intracameral bimatoprost implant limited to a single implant per eye; iDose TR is a nonbiodegradable titanium implant containing 75 mcg travoprost, anchored in the sclera through the trabecular meshwork using gonioscopy, with readministration permitted no more than once per year subject to corneal endothelial cell density criteria; topical Lumigan 0.01% is dosed once daily. The BIM-IOL System places two nonbioerodible pads containing 78 mcg bimatoprost (phase 3 dose) on an IOL in the capsular bag during cataract surgery, with a sponsor-stated design duration of three years, and is therefore limited to eyes undergoing cataract surgery; retreatment would require the separate BIM-DRS in development. Reported conjunctival hyperemia rates were 31% with Lumigan 0.01% and 27% with Durysta in their labeling, compared with 1 of 23 participants (4.3%) in the nonrandomized BIM-IOL first-in-human study; these are cross-trial observations with different designs. The iDose TR wholesale acquisition cost announced by Glaukos is $13,950 per implant; no BIM-IOL System price has been announced.

Sustained-release glaucoma therapies: review comparison table

Product	Developer	Active agent	Route of administration	Duration of action	Development stage
Durysta	“Allergan, North Chicago, IL, USA”	“Bimatoprost”	“Biodegradable intracameral implant”	“4–6 months”	“FDA approved”
iDose TR	“Glaukos, Aliso Viejo, CA, USA”	“Travoprost”	“Non-degradable implant”	“Up to 36 months”	“FDA approved”
Paxtrava	“Ocular Therapeutix, Bedford, MA, USA”	“Travoprost”	“Biodegradable intracameral implant”	“6 months”	“Phase II NCT05335122”
Bimatoprost ocular ring	“Allergan, North Chicago, IL, USA”	“Bimatoprost”	“Nondegradable ring inserted into the conjunctival fornices”	“Up to 6 months”	“Phase II”
SpyGlass System	“SpyGlass Pharma, Aliso Viejo, CA, USA”	“Bimatoprost”	“IOL pads eluting bimatoprost”	“Up to 3 years”	“Phase I/II”

Single-use limitation of approved intracameral implants: review

“Currently, the two available intracameral implants are only approved by the FDA for single use due to safety issues. The travoprost implant is not degradable, and if the drug is depleted, the implant must be removed and re-administered.” (opens the source at this quote in a new tab)

Durysta: dosage form, administration limit, and efficacy versus timolol

“DURYSTA is an ophthalmic drug delivery system for a single intracameral administration of a biodegradable implant. DURYSTA should not be readministered to an eye that received a prior DURYSTA.” (opens the source at this quote in a new tab)
“Intracameral implant containing 10 mcg of bimatoprost in a drug delivery system.” (opens the source at this quote in a new tab)
“Efficacy was evaluated in two multicenter, randomized, parallel-group, controlled 20-month (including 8-month extended follow-up) studies of DURYSTA compared to twice daily topical timolol 0.5% drops, in patients with OAG or OHT. DURYSTA demonstrated an IOP reduction of approximately 5-8 mmHg in patients with a mean baseline IOP of 24.5 mmHg (see Figures 3 and 4).” (opens the source at this quote in a new tab)
“The most common ocular adverse reaction observed in two randomized, active-controlled clinical trials with DURYSTA in patients with OAG or OHT was conjunctival hyperemia, which was reported in 27% of patients.” (opens the source at this quote in a new tab)

iDose TR: dosage form, implantation, readministration, and efficacy versus timolol

“Intracameral implant containing 75 mcg travoprost, pre-loaded in a single-dose inserter.” (opens the source at this quote in a new tab)
“iDose TR is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle.” (opens the source at this quote in a new tab)
“It is not recommended to readminister an iDose TR more than once per year.” (opens the source at this quote in a new tab)
“iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. Subsequently, iDose TR did not demonstrate non-inferiority over the next 9 months.” (opens the source at this quote in a new tab)
“Dislocation of the iDose TR has been observed in clinical trials. Patients should be monitored routinely to confirm the location of the iDose TR at the site of administration.” (opens the source at this quote in a new tab)

Topical bimatoprost: dosing, efficacy, and conjunctival hyperemia

“The recommended dosage is one drop in the affected eye(s) once daily in the evening.” (opens the source at this quote in a new tab)
“In a 12-month clinical study of patients with open angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mmHg, the IOP-lowering effect of LUMIGAN® 0.01% once daily (in the evening) was up to 7.5 mmHg.” (opens the source at this quote in a new tab)
“In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia.” (opens the source at this quote in a new tab)

Sponsor-stated differentiation from intracameral implants and MIGS

“Similarly, novel procedural pharmaceuticals such as intracameral implants offer sustained drug delivery, but present their own limitations. These implants are placed near the cornea and iris, which can result in corneal endothelial cell loss, inflammation, or other complications. Similar to MIGS, non-bioerodible intracameral implants also require specialized training, use of nondominant hand, mid-surgery adjustments of the patient and microscope, and additional post-operative follow-up care. To date, adoption of these implants has been limited.” (opens the source at this quote in a new tab)

Cross-trial comparison with trabecular bypass MIGS: first-in-human study

“In medication-washout clinical trials of trabecular bypass devices combined with CEIOL, mean IOP reduction ranged from 31.1 to 36.9%, reduction > 20% was achieved by 75.8 to 80.0% of subjects, and medication-free rates at 1 year were 77.1 to 85% [18–22]. The currently studied drug delivery system appeared comparable in magnitude to published MIGS outcomes, although cross-trial comparisons are exploratory and hypothesis-generating only.” (opens the source at this quote in a new tab)
“As with any investigation that examines a technology paired with cataract extraction, one must consider the standalone 2–4 mmHg reduction achieved by the latter in glaucoma populations [26, 27]. We did not include a CEIOL-only group comparator, which should be considered in future trials.” (opens the source at this quote in a new tab)

Sponsor-identified competitors

“Our lead product candidate, the BIM-IOL System, is designed to treat OAG and OHT, placing us in direct competition with a range of therapies, devices, procedures and technologies, including topical eye drops, laser-based interventions, MIGS, and intracameral implants.” (opens the source at this quote in a new tab)

Head-to-head comparison of the BIM-IOL System with Durysta, iDose TR, SLT, or MIGS

No evidence found.