SpyGlass Pharma, Inc. recently announced positive 4-year data from the first-in-human (FIH) trial results for the bimatoprost drug pad-IOL system (BIM-IOL System).
Let’s begin with this system.
SpyGlass’s lead candidate, the 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 mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (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.
Didn’t I just hear about SpyGlass in the news?
Indeed. The company unveiled positive 12-month data on the system from the phase 1/2 TIGRIS trial (NCT06120842) earlier this month during the American Academy of Ophthalmology (AAO) annual meeting in New Orleans, Louisiana.
A rundown of that data: After 12 months, investigators determined that both doses of BIM-IOL (39 and 78 mcg) resulted in “clinically meaningful IOP reduction and high rates of medication independence:”
- IOP reduction: ~9 mmHg from baseline (~35% reduction) at 12 months 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%)
- 8 a.m. change, mmHg (%)
- Medication independence: A total of 98% and 95.7% of BIM-IOL participants were reported to be medication free in the 78 mcg and 39 mcg arms, respectively.
Read more about the findings here.
Let’s move on to the FIH trial.
The study is a single-center, prospective trial evaluating the BIM-IOL System for the treatment of elevated IOP in patients with mild-to-moderate OAG or OHT undergoing routine cataract surgery.
- Note: The BIM-IOL System in the FIH trial is designed to deliver bimatoprost for up to 7 years.
The cohort: 23 patients who were sequentially assigned 1:1:1 across three dosage groups (75 mcg, 150 mcg and 300 mcg).
- At the 48-month timepoint, 21 evaluable patients remained; one patient moved outside the country and another was discontinued after receiving a cancer diagnosis.
What should we know about the prior data from the FIH trial?
We last reported on this study in November 2025, when the company announced 36-month follow-up results.
Those key findings:
- A 37% reduction in mean IOP was observed among evaluable patients across all three dose groups.
- A total of 95% of evaluable patients were also off topical IOP-lowering medications by the 36-month mark—and 100% of these patients achieved 20/30 or better best-corrected distance visual acuity (BCDVA).
- No product-related adverse events (AEs) were reported.
Now that the stage is set … what about this most recent data?
The interim safety and efficacy data collected from the 21 evaluable patients at the 4-year timepoint are as follows:
- 37% reduction in mean IOP across all three dose groups from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.8 mmHg
- 86% (18 of 21) of patients remained off all topical IOP-lowering drops
- 90% of patients maintained ≥20/25 BCDVA
- No product-related AEs were reported
Any comments from the company?
Patrick Mooney, CEO of SpyGlass Pharma, highlighted that these findings “mark the first time a sustained drug delivery implant for glaucoma therapy has demonstrated durable safety and efficacy results for 4 years.”
- Plus: “These remarkable results further underscore the significant potential for the BIM-IOL System to change the treatment paradigm for glaucoma patients undergoing cataract surgery.”
How? By fitting “directly into every cataract surgeon’s workflow to address two of the leading causes of preventable blindness in a single procedure: restoring vision from cataracts and lowering IOP to preserve a patient’s precious sight.”
When can we expect an update?
SpyGlass plans to continue long-term follow-up of patients in both the FIH trial and phase 1/2 trial as well as patient enrollment in ongoing phase 3 clinical trials (RHINE [NCT07218783] and RHONE [NCT07218796]).
While an exact date wasn’t provided, the company is working with the FDA to advance the program through 505(b)(2) New Drug Application (NDA) submission and ultimately to potential commercial approval.