SpyGlass Pharma is reporting positive findings from two clinical trials evaluating its sustained-release drug delivery platform for open-angle glaucoma (OAG) or ocular hypertension (OHT).
This data includes 36-month follow-up results from a first-in-human (FIH) study as well as 3-month interim safety and efficacy outcomes from a phase 1/2 trial.
First things first: Talk about this platform.
Its name: The bimatoprost drug pad-intraocular lens system (BIM-IOL System), the company’s lead investigational candidate that performs IOL implantation during cataract surgery.
- Its purpose: To consistently deliver multiple years—ideally: 3 years—of bimatoprost for the reduction of intraocular pressure (IOP) in patients with OAG or OHT.
- See here for details on its design and click here for a visual of it in action.
Why use bimatoprost to lower IOP?
Check out this reasoning for why the platform utilizes the prostaglandin analog (PA).
Alrighty, now to this new data: Start with the FIH trial.
We last reported on this study in April 2025, when the company presented 18-month findings at the 2025 annual American Society for Cataract and Refractive Surgeons (ASCRS) meeting.
- With that in mind, see here for details on the study’s setup.
What should we know about the prior data on it?
The 18-month post-op results were based on data from the half-way point of the study’s 3-year duration, with 23 patients receiving one of three varying doses of bimatoprost via the BIM-IOL system.
- Notably, the company reported on vision improvements and IOP reduction.
While investigators noted “promising visual outcomes,” the need for longer-term data was emphasized to determine the system’s “potential for multi-year durability of both visual outcomes and IOP-lowering efficacy.”
Enter in … this new data?
Indeed. In the latest reporting, 36-month follow-up findings found a 37% reduction in mean IOP among evaluable patients across all three dose groups.
- The numbers: 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.7 mmHg.
Importantly: 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).
Any adverse events?
None that were product-related, according to SpyGlass.
Nice! And the conclusions drawn from this?
As SpyGlass co-founder and President Malik Kahook, MD, noted, the long-term data demonstrates the platform’s ability to “deliver sustained IOP reduction, drop-free outcomes, and strong visual performance for 3 years.”
Now let’s move on to that phase 1/2 trial mentioned earlier …
Ah yes. This ongoing (through November 2027) study is, essentially, designed to support the FIH trial’s findings across a larger population of OHT and OAG patients.
What to know about it: Dubbed Tigris, all the details on the phase 1/2 randomized, multicenter, controlled trial (NCT06120842) is evaluating patients treated with either the BIM-IOL system (low and high doses) or timolol maleate ophthalmic solution, USP, 0.05%.
- More details on its setup and outcome measures can be found here.
And what’s the latest reporting?
Three-month data that, according to Dr. Kahook, demonstrates “similar IOP reduction and drop-free outcomes” to those seen in the FIH trial.
More specifically: A 37% and 36% reduction in mean IOP with 98% and 96% of patients off topical IOP-lowering drops in the 78 mcg (high) and 39 mcg (low) dose groups, respectively.
Comparatively: A 37% reduction was observed in the control group
And how did patients’ visual function fare?
In both BIM-IOL-dosed groups and the control group: 100% of patients achieved 20/40 or better BCDVA (with a mean 20/20 BCDVA).
Overall, SpyGlass reported safety results were “comparable to routine cataract surgery.”
How about adverse events?
These were notably similar across both BIM-IOL groups—35.3% (high) and 39.1% (low)—as well as the control group (33.3%).
Plus: No serious ocular AEs were observed.
So what’s next for this candidate?
As we mentioned, that phase 1/2 study is still ongoing through the next 2 years … so additional data is expected to be reported.
In the meantime, though, Dr. Kahook emphasized the big-picture significance for the two datasets, noting that “these results represent an important milestone … for patients in need of disease control while removing the adherence burden” of IOP-lowering drops for OHT and OAG.
These findings were presented by Dr. Kahook during the Interventional Glaucoma Consortium (IGC) in Salt Lake City, Utah, on Nov. 8.