Interim 12-month safety and efficacy data on SpyGlass Pharma’s bimatoprost drug pad-intraocular lens system (BIM-IOL System) were presented over the weekend during the American Academy of Ophthalmology (AAO) annual meeting in New Orleans, Louisiana.
The findings offered a closer look at the safety and initial efficacy of this investigational system among glaucoma and ocular hypertensive (OHT) patients.
Let’s begin with this system.
SpyGlass’s lead candidate, the bimatoprost drug pad-intraocular lens system (BIM-IOL System), combines a monofocal IOL with sustained-release bimatoprost pads and is implanted by the surgeon during routine cataract surgery.
But more specifically: The system is designed to consistently deliver bimatoprost for 3 years to reduce intraocular pressure (IOP) in patients with OAG or OHT.
- Check out more on its design—which includes two drug-eluting pads—and mechanism of action (MOA).
- As for why the platform utilizes bimatoprost, an FDA-approved prostaglandin analog (PA), see here.
And in recent news: A new add-on Category III Current Procedural Terminology (CPT) code was approved earlier this year to support the system.
Can we get a look at its past clinical performance?
See here for 36-month follow-up data from a first-in-human (FIH) study conducted on the BIM-IOL System.
The gist of that dataset: A 37% reduction in mean IOP was observed among evaluable patients across all three dose groups.
Now to this AAO reporting.
These 12-month interim results come from the prospective, multicenter, double-masked, controlled phase 1/2 TIGRIS study (NCT06120842) evaluating the BIM-IOL System’s safety and efficacy.
To note: We previously reported 3-month interim safety data from this study back in November 2025.
Duly noted. Can we get a quick rundown on its details?
The participants: 104 total patients with mild-to-moderate open-angle glaucoma (OAG: 85%) or OHT (15%), all undergoing cataract surgery.
- Mean age: 70.2 ± 7.04 years (range: 53–84; 51% female)
- Race: 58% White, 25% Asian, 16% Black
- At screening:
- Mean IOP: 20.11 ± 4.52 mmHg (range 10.0–34.0)
- IOP-lowering medications: 0 meds (33%); 1 med (41%); 2 meds (14%); 3 meds (12%)
- All patients underwent a washout before baseline.
And the study’s setup?
Participants were randomized 2:1:1 into three arms:
- BIM-IOL 78 mcg + artificial tears twice daily BID (n=51)
- BIM-IOL 39 mcg + artificial tears BID (n=23)
- Control: commercial IOL + topical timolol BID (n=30)
- Specifically: timolol maleate ophthalmic solution, USP, 0.5%.
What was measured?
The primary endpoint was IOP reduction measured twice a day (8 a.m. and 10 a.m.) at 2 weeks, 6 weeks, 6 weeks, and 3 months.
Additional endpoints included:
- IOP reduction through 36 months
- Visual performance measures—best-corrected distance visual acuity (BCDVA) and manifest refraction spherical equivalent (MRSE)—at 12 months
- Safety (adverse events [AEs])
Now to the 12-month results.
We’ll start with the primary outcome: Investigators observed a mean IOP reduction of ~9 mmHg from baseline (~35% reduction) at 12 months that was compared to control.
- 8 a.m. change, mmHg (%)
- 78 mcg: −8.85 (−34.4%)
- 39 mcg: −11.36 (−42.2%)
- Control: −9.14 (−34.9%)
- 10 a.m. change, mmHg (%)
- 78 mcg: −8.36 (−33.3%)
- 39 mcg: −9.98 (−39.9%)
- Control: −9.07 (−35.2%)
Were any additional IOP medications needed at 12 months?
A total of 98% of BIM-IOL 78 mcg participants were reported to be medication free.
Compare that to 95.7% and 100% of patients in the 39 mcg and control arms, respectively.
Translation: Control patients required no additional IOP-lowering medications beyond the protocol-assigned timolol..
Now to VA and refractive predictability outcomes.
Across all arms, the mean BCDVA was 20/20 (~86 letters), while 100% of eyes achieved a BCDVA of ≥ 20/32 or better.
- The numbers: 74% (78 mcg), 65% (39 mcg), and 63% (control) of eyes achieved a BCDVA of 20/20 or better.
As for MRSE, the following was observed at 3 months (SD) and 12 months (SD), respectively:
- 78 mcg: 0.35 (0.28); 0.44 (0.32)
- 39 mcg: 0.32 (0.24); 0.34 (0.37)
- Control: 0.31 (0.38); 0.28 (0.49)
Any adverse events to take note of?
The big picture: Investigators observed no serious ocular AEs (SOAEs), secondary surgical interventions (SSIs), or explantations over the 12-month period.
In fact, “safety was comparable across all three treatment arms, with endothelial cell loss remaining stable and consistent with routine cataract surgery” throughout the 12-month interim analysis.
Can we get specific numbers on this?
Patients with any AE accounted for:
- 41.2% (21 patients, 32 events) at 78 mcg
- 43.5% (10 patients, 17 events) at 39 mcg
- 36.7% (11 patients, 15 events) in control
As for endothelial cell density (ECD): Mean ECD went from:
- 2,612 to 2,291 cells/mm² at 78 mcg
- 2,577 to 2,104 cells/mm² at 39 mcg
- 2,525 to 2,270 cells/mm² in control
Any study limitations to keep in mind when interpreting this data?
But of course. Four were called out:
- These are interim results; durability needs longer follow-up.
- The operating surgeon couldn't be masked (but IOP assessors were).
- Patients entered on 0 to 3 medications, with washout periods of different lengths.
- To note: This is standard practice for glaucoma trials.
- Only OHT and mild-to-moderate OAG were studied.
Now compare this to that aforementioned 3-month data.
A few key numbers to consider:
- Mean IOP reduction went from 37% to 34% at 78 mcg and from 36% to 42% at 39 mcg.
- See here for that 3-month reporting.
- Drop-free rates were relatively steady, at 98% and 96%.
- Any-AE rates rose from a 35.3%–39.1% range to 36.7%–43.5%.
- For context, see the 3-month reporting here.
So, in a nutshell, what did investigators take away from the results?
After this 12-month period, they determined that both doses of BIM-IOL (39 mcg and 78 mcg) resulted in “clinically meaningful IOP reduction and high rates of medication independence.”
Plus, the safety results were deemed “comparable to routine cataract surgery”—with no serious AEs.
Noted. Last question: When was this data presented—and by who?
These results are based on the AAO presentation titled Interim 12-Month Safety & Efficacy Results from a Phase 1/2 Clinical Trial, which was presented on Saturday, Oct. 10.
- The presenter: Jeffrey A. Kammer, MD
- His credentials: Associate Professor of Ophthalmology, Department of Ophthalmology and Visual Sciences, Vanderbilt University Medical Center
Editor’s note: This article was updated on Oct. 14, 2026.