Summary

The BIM-IOL System is investigational and has no guideline-defined place in therapy. Its studied use is a single implantation during routine cataract surgery, placed in the capsular bag, in adults with mild to moderate OAG or OHT and a concomitant cataract. The phase 3 trials SGP-005 (Rhine) and SGP-006 (Rhone), each planned for about 400 participants, enroll patients taking up to two IOP-lowering medications and compare the 78 mcg system with a commercial monofocal IOL plus twice-daily timolol. Guidelines currently offer patients with glaucoma and cataract whose IOP is at or near target on one or two medications cataract surgery alone or cataract surgery with MIGS; the BIM-IOL System would be an additional option in this setting, and the manufacturer positions it for surgeons who do not perform angle-based MIGS. The AAO guideline states that sustained medication delivery methods may be better options for patients who find drop administration very difficult. The manufacturer designs the pads to deliver bimatoprost for about 3 years; retreatment would require the separate investigational BIM-DRS. Cataract surgery in the United States is performed mainly in ambulatory surgery centers (manufacturer estimate about 90%), and a Category III add-on CPT code was approved in May 2026 for use with cataract surgery codes. The manufacturer estimates about one million US cataract surgeries per year in patients with glaucoma or OHT. Cataract surgery alone lowered IOP by 16.5% in the OHTS observation group, and no comparison of the BIM-IOL System with cataract surgery alone or with MIGS combined with cataract surgery is available.

Anticipated use: implantation during routine cataract surgery

“Our lead product candidate, the BIM-IOL System, is being developed for the reduction of IOP in patients with OAG or OHT who are undergoing cataract surgery.” (opens the source at this quote in a new tab)
“The BIM-IOL System is designed to address key limitations of current glaucoma care by enabling all cataract surgeons, not just those trained in MIGS, to treat elevated IOP when performing their routine cataract procedures, thereby reducing the reliance on patient adherence to topical medications in managing IOP.” (opens the source at this quote in a new tab)
“We believe the BIM-IOL System could redefine the current standard of care for OAG and OHT patients undergoing cataract surgery.” (opens the source at this quote in a new tab)

Studied population: phase 3 registrational trials

“Each prospective, multicenter, randomized, masked, controlled Phase 3 clinical trial evaluates the safety and efficacy of the BIM-IOL System (78 mcg) in patients with OAG or OHT and a concomitant cataract, who are taking up to two IOP-lowering medications.” (opens the source at this quote in a new tab)
“Each trial is expected to enroll approximately 400 patients across 45 clinical sites.” (opens the source at this quote in a new tab)

Studied population: registry eligibility for the Rhine trial

Field	Quoted record
Inclusion	“Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension”; “Planned removal of cataract”
Exclusion	“Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma”; “History of incisional glaucoma surgery or intraocular injections”; “History of incisional/refractive corneal surgery”
Planned enrollment	“400”

Duration of therapy and retreatment pathway

“The BIM-IOL System is designed for long-acting, sustained delivery of bimatoprost over three years, which we believe can reduce or eliminate the need for daily topical medications.” (opens the source at this quote in a new tab)
“The BIM-DRS is designed to consistently deliver at least three years of bimatoprost and is intended to provide IOP-lowering therapy beyond the initial three-year duration that we are targeting with the BIM-IOL System.” (opens the source at this quote in a new tab)

Guideline setting for combined treatment at cataract surgery

“Q7. What is the recommended approach for patients with early or moderate open-angle glaucoma and visually significant cataracts?” (opens the source at this quote in a new tab)
“– IOP at or near target: Phacoemulsification alone or phacoemulsification with MIGS.” (opens the source at this quote in a new tab)

Patients with difficulty administering drops

“Drop administration may be exceedingly difficult for some patients, and laser trabeculoplasty surgery, sustained medication delivery methods, or other surgery may be better options for these patients.” (opens the source at this quote in a new tab)

Angle-sparing placement and compatibility with later procedures

“First, the implantation of the system is highly accessible to all surgeons who routinely perform CEIOL procedures. Second, it leaves the angle untouched, allowing for concurrent or subsequent gonioscopic intervention, or subsequent selective laser trabeculoplasty. Third, the positioning of the system within the capsular bag may limit mechanical injury to the corneal endothelium.” (opens the source at this quote in a new tab)

Care setting and reimbursement pathway

“We believe this presents an opportunity for providers and facilities, including ASCs, where approximately 90% of cataract surgeries in the United States are performed” (opens the source at this quote in a new tab)
“We believe that the IOP-lowering element of our lead product candidate will be classified as a physician-administered drug, which are typically reimbursed at the ASP plus 6%.” (opens the source at this quote in a new tab)

“In May 2026, the American Medical Association’s CPT® (Current Procedural Terminology) Editorial Panel approved a new add-on Category III CPT code (+1090T released to AMA website on July 1, 2026) in combination with established Category I CPT codes, such as 66984 and 66991.” (opens the source at this quote in a new tab)

Anticipated population size (manufacturer estimate)

“We remain deeply focused on delivering long-term, eye drop-free therapy for the approximately one million glaucoma and ocular hypertension patients who undergo cataract surgery in the United States each year.” (opens the source at this quote in a new tab)