BIM-IOL System

No phase 3 results and no peer-reviewed randomized results are available for the BIM-IOL System. Efficacy evidence consists of one published nonrandomized first-in-human study with its observational extension, and sponsor-reported topline results from one randomized phase 1/2 trial.

In the first-in-human study (SGP-SPEC-001, extended as SGP-SPEC-004), a single surgeon in Honduras implanted systems containing 75, 150, or 300 μg of bimatoprost in 24 participants (8 per cohort), all with POAG and of Hispanic or Latino ethnicity; 23 were analyzed per protocol after exclusion of one participant with preexisting diabetic retinopathy. Mean post-washout baseline IOP was 25.1 ± 2.5 mmHg. At month 6, every study eye had an unmedicated IOP reduction of at least 20%. At month 36 (21 participants), mean IOP was 15.9 ± 2.8 mmHg, a mean reduction of 36.7 ± 9.4% (p < 0.0001); all 21 eyes maintained a reduction greater than 20%, 19 (90.5%) had IOP below 18 mmHg, and 20 (95.2%) were free of topical medication. IOP change did not differ among dose cohorts (p = 0.50 at month 36).

In the phase 1/2 trial (SGP-003, Tigris), 104 participants undergoing cataract surgery were randomized 2:1:1 to the 78 mcg system (51), the 39 mcg system (23), or a commercial monofocal IOL plus twice-daily timolol (30). At 3 months, mean IOP reductions at 8 a.m. were 37%, 36%, and 37%, and 49 of 50 (98%) and 22 of 23 (96%) participants in the 78 mcg and 39 mcg groups were free of topical IOP-lowering medication. At 12 months, mean IOP reductions were 34% (47 evaluable), 42% (21), and 35% (29); 48 of 49 (98%) and 22 of 23 (96%) participants in the 78 mcg and 39 mcg groups were medication free; and 72 of 72 (100%) evaluable BIM-IOL participants had BCDVA of 20/32 or better. No confidence intervals, p values, or noninferiority analyses have been published.

In the phase 1/2 trial, adverse event rates were 35.3% (78 mcg), 39.1% (39 mcg), and 33.3% (control) at 3 months and 41.2%, 43.5%, and 36.7% at 12 months, with no serious ocular adverse events; one participant (1 of 50, 2.0%) receiving the system reported allergic conjunctivitis, and mean endothelial cell density loss at 3 months was 14.9% with the system and 12.1% with control. In the first-in-human study through 36 months, the most common adverse events were dry eye (5 of 23, 21.7%), transient loss of 2 or more lines of BCDVA (3, 13.0%), and subconjunctival hemorrhage (2, 8.7%); conjunctival hyperemia occurred in 1 participant (4.3%). There were no implant-related serious adverse events, IOL dislocations, drug pad displacements, or explantations, and endothelial cell density decreased by 12.8% at month 12.

The sources disagree on several points. The phase 1/2 registry record lists an actual enrollment of 201, whereas all company disclosures report 104 randomized participants. The 12-month medication-free rate is reported by dose group as 98% and 96%, and as a pooled 97% in the Form 10-K and a trade-journal article. The 78 mcg IOP reduction decreased from 37% at 3 months to 34% at 12 months, which the Form 10-K describes as "sustained similar rates"; the 12-month IOP denominators (47, 21, and 29) differ from the medication-free denominators (49 and 23). For the first-in-human study, enrollment is 24 in the registry and publication and 23 in company materials; the month 36 IOP is reported as 15.9 ± 2.8 mmHg in the publication and Form 10-K and 15.9 ± 2.7 mmHg in a November 2025 company announcement; the month 18 IOP is 13.9 ± 2.2 mmHg (44.4% reduction) in the publication, 14.1 ± 2.6 mmHg in a trade report of the 2025 ASCRS presentation, and a 43.7% reduction in an AAO news report; and the registry describes the study as "controlled" with a masked outcomes assessor, whereas the publication reports no control group and states that neither participants nor investigators were masked. For the phase 3 trials, the registry lists the BCDVA co-primary endpoint at month 6, whereas the Form 10-K states 12 months, and the Form 10-K states that the trials were initiated in July 2025, whereas the registry start dates are October 15, 2025 (SGP-005, actual) and October 28, 2025 (SGP-006, estimated). A March 2026 company announcement describes the system as delivering "multiple years" of bimatoprost, whereas the Form 10-K and later announcements specify three years.

The registrational phase 3 trials SGP-005 (Rhine) and SGP-006 (Rhone) each plan to enroll approximately 400 participants and compare the 78 mcg system with a commercial monofocal IOL plus twice-daily timolol 0.5%, with follow-up through 36 months. The sponsor expects enrollment to complete in 2027 and 12-month data in 2028.