Clinical development for a
future beyond daily drops
Positive results for the BIM-IOL System
The SpyGlass BIM-IOL System is being evaluated through preclinical and clinical trials designed to assess long-term drug delivery, safety, efficacy and durability.* Positive results from multiple clinical trials demonstrate the system’s potential to deliver sustained bimatoprost therapy and maintain visual outcomes comparable to conventional cataract surgery.1,2
In vitro long-term release trial*
Objective: Evaluate bimatoprost release from the BIM-IOL System in vitro.1
Results: Data demonstrated consistent daily release of bimatoprost for more than 3 years, confirming the system's ability to provide sustained, predictable dosing over
multi-year periods.1
multi-year periods.1
Consistent Daily Release of Bimatoprost Maintained More Than 3 Years In Vitro1
First-in-Human (FIH) clinical trial
Objective: Assess the safety and efficacy of the BIM-IOL System containing 75 mcg, 150 mcg, and 300 mcg of bimatoprost.1
Enrollment: Completed June 2022.1
View study design1
- Single-center, ex-US prospective trial designed to assess safety and efficacy of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery
- 23 patients previously on 1 to 3 topical IOP-lowering medications enrolled following a baseline medication washout period
- Participants assigned 1:1:1 to receive the BIM-IOL System containing 75 mcg, 150 mcg, or 300 mcg of bimatoprost
- BIM-IOL System implanted at the time of cataract surgery
- Multiple time points of follow-up, including at 1, 3, 6, 9, 12, 18 and 36 months. Patients will continue to be followed through 7 years
- Primary efficacy endpoints (assessed at each follow-up time-point):
- Topical glaucoma medication use
- IOP reduction from baseline
- Primary safety endpoints:
- Best corrected distance visual acuity (BCDVA)
- Adverse event (AE) assessment and slit-lamp examinations
- Endothelial cell density measurement at 12 months
Key efficacy results at 36 months:
37%
mean IOP reduction across all dose groups2
95%
of evaluable patients off all topical IOP-lowering medications2
100%
of evaluable patients achieved BCDVA ≥20/302
No significant differences in IOP reduction among dose groups2
Mean IOP Reduction Sustained Through 36 Months Across All Doses3
†Two subjects were discontinued prior to the 36-month visit: 1 subject withdrew consent after moving outside the country and 1 subject was discontinued after receiving a pancreatic cancer diagnosis and was undergoing palliative care.
Patients with BCDVA of 20/30 or better across all doses
At screening1
35%
N=23
At 36 months2
100%
N=21
Safety results:
- No product-related adverse events (AEs) were reported2
Phase 1/2 Clinical Trial
Objective: Compare safety and IOP-lowering efficacy of two BIM-IOL System doses (39 mcg and 78 mcg) versus timolol maleate 0.5% in patients with OAG or OHT undergoing cataract surgery.1
Enrollment: Completed November 2024; 12-month interim data reported March 2026.1,4
View study design1
- Prospective, multicenter, randomized, double-masked, controlled trial conducted in patients with OAG or OHT undergoing cataract surgery
- 104 patients enrolled and randomized in a 2:1:1 ratio into 3 treatment groups:
- BIM-IOL System (78 mcg) and daily artificial tears
- BIM-IOL System (39 mcg) and daily artificial tears
- Timolol: monofocal IOL + topical timolol maleate 0.5% twice daily
- All patients underwent baseline washout of IOP-lowering medications
- Follow-up visits conducted at 2 weeks, 6 weeks, and 3 months, with continued observation planned through 36 months
- Primary endpoint: Time-matched mean IOP reduction from baseline at Week 2, Week 6, and Month 3
- IOP measurements taken at 2 time points per visit (8 AM and 10 AM)
- Secondary endpoints:
- Mean IOP reduction from baseline
- Mean IOP time to reintroduction and number of IOP-lowering medications
- Proportion of eyes achieving BCDVA ≥20/40 at Months 3, 6, and 12
- Safety assessments:
- AEs related to IOL implantation and PGA use
- Endothelial cell density
- Findings from slit-lamp examination
- Patient-reported quality of vision
Key topline efficacy results at 12 months:
78-mcg dose group
34%
mean IOP
reduction4
98%
of patients off all
IOP-lowering medications4
Both dose groups
100%
of evaluable patients achieved BCDVA of ≥20/324
Phase 1/2 data show sustained IOP reduction and drop-free
outcomes from 3 to 12 months2-4
Mean IOP Change (78-mcg Dose Group)
Percentage of Patients Free From All Topical
IOP-lowering Medications (78-mcg Dose Group)
At 12 months
100% of evaluable patients (N=72) achieved:
- BCDVA OF ≥20/32
- MEAN BCDVA EQUIVALENT TO 20/20 VISION4
Mean BCDVA by Number of Letters Read3,5
The BIM-IOL System achieved comparable visual performance to state-of-the-art IOLs4
Overall safety results were comparable to routine cataract surgery
Adverse event (AE) rates were similar across the 78-mcg (41.2%) and control (36.7%) groups4
No serious ocular AEs were observed4
Phase 3 Clinical Trials
We have initiated two identical, registrational, Phase 3 clinical trials to evaluate and compare IOP-lowering efficacy, BCDVA outcomes, and safety of the BIM-IOL System (78 mcg) versus standard of care in patients with OAG or OHT undergoing cataract surgery. Participants will be followed through 36 months, allowing us to compare long-term safety, efficacy, and durability. Each trial is expected to enroll approximately 400 patients across 45 clinical sites.1*
View study design1
- Two parallel prospective, multicenter, randomized, masked, controlled Phase 3 trials designed to support regulatory submission
- Both trials were designed to demonstrate noninferiority of the BIM-IOL System compared to the standard of care (monofocal IOL + timolol)
- Each trial will enroll approximately 400 patients across 45 clinical sites in the US, New Zealand, and Asia
- Participants will be randomized 1:1 to receive either:
- BIM-IOL System (78 mcg)
and artificial tears - Surgeon's choice of monofocal IOL with daily topical timolol maleate 0.5% twice daily
- BIM-IOL System (78 mcg)
- All patients will undergo a baseline washout of IOP-lowering medications prior to surgery and receive treatment in the study eye
Identical Design for Each of the Two Phase 3 Clinical Trials (SGP-005 and SGP-006)
- Co-primary endpoints:
- Time-matched mean IOP change from baseline (8 AM and 10 AM measurements)
at 2 weeks, 6 weeks, and
3 months - BCDVA of 20/40 or better
at 12 months
- Time-matched mean IOP change from baseline (8 AM and 10 AM measurements)
- Secondary endpoint:
- IOP change from baseline
- Time to postoperative introduction of IOP-lowering medications
- Number of IOP-lowering medications introduced postoperatively
- Trial duration:
- Participants will be followed through 36 months to assess long-term safety, efficacy, and durability of IOP control
Seamless integration into cataract surgery
Jeffrey A. Kammer, MD
Phase 1/2 results: safety & efficacy overview
Jeffrey A. Kammer, MD
What sustained delivery means for patients
Jeffrey A. Kammer, MD
Seamless integration into cataract surgery
Jeffrey A. Kammer, MD
Phase 1/2 results: safety & efficacy overview
Jeffrey A. Kammer, MD
What sustained delivery means for patients
Jeffrey A. Kammer, MD
Phase 1/2 results: safety & efficacy overview
Jeffrey A. Kammer, MD
What sustained delivery means for patients
Jeffrey A. Kammer, MD
Seamless integration into cataract surgery
Jeffrey A. Kammer, MD
Phase 1/2 results: safety & efficacy overview
Jeffrey A. Kammer, MD
What sustained delivery means for patients
Jeffrey A. Kammer, MD
Seamless integration into cataract surgery
Jeffrey A. Kammer, MD
Phase 1/2 results: safety & efficacy overview
Jeffrey A. Kammer, MD
What sustained delivery means for patients
Jeffrey A. Kammer, MD
Seamless integration into cataract surgery
Jeffrey A. Kammer, MD
Phase 1/2 results: safety & efficacy overview
Jeffrey A. Kammer, MD
What sustained delivery means for patients
Jeffrey A. Kammer, MD
Seamless integration into cataract surgery
Jeffrey A. Kammer, MD