SpyGlass Pharma released new data from a first-in-human (FIH) study evaluating the use of its drug delivery platform for the long-term treatment of glaucoma and ocular hypertension (OHT).
The latest findings are being presented at the 2025 annual meeting of the American Society for Cataract and Refractive Surgeons (ASCRS) this weekend.
Where to begin?
We’ll start with this drug delivery platform—noted by the company as “the first and only controlled release drug delivery platform for all cataract surgeons.”
What it is: The SpyGlass Pharma Drug Delivery Platform comprises a single-piece, hydrophobic acrylic intraocular lens (IOL) with two drug-eluting pads—which act as “bladders” that securely attach to the haptics of the IOL.
- The IOL’s purpose: The lens is implanted directly into the capsular bag during cataract surgery
- As for those drug-eluting pads: These are positioned outside the visual access to continuously elute directly into the aqueous humor
The duration target: A sustained delivery of bimatoprost therapy to lower IOP over a 3-year period.
Can I get a visual of this in action?
Check it out.
Take note: The platform is still under investigational use and has not yet been cleared by the FDA.
Why use bimatoprost?
Bimatoprost is a prostaglandin analog (PA; also known as a synthetic drug)—a class of medications that mimic the effect of natural prostaglandins in the body to promote aqueous humor outflow.
- Their purpose: PAs are commonly used as a first-line treatment for both glaucoma and OHT.
How they work: Formulated as ophthalmic solutions (administered either as eye drops or injections), these medications lower IOP by increasing the flow of natural fluids out of the eye.
- Notably, other forms of PAs include latanopost and travoprost.
- However, bimatoprost has been found to generally be more effective in lowering IOP than other PAs.
Got it. Now to this trial.
The single-center, prospective, cohort study enrolled 23 patients (no specific age range provided) diagnosed with visually-significant cataract and concomitant (mild-to-moderate) open-angle glaucoma (OAG) or OHT.
The setup: All participants (23 eyes) were implanted with a monofocal IOL mounted sustained-release bimatoprost—of which they were treated across three doses:
- 75 mcg
- 150 mcg
- 300 mcg
Post-impantation: All eyes were examined at regular intervals up to 3 years.
And what was examined in these 36-month follow-up visits?
Both safety and efficacy were analyzed via such measurements as:
- Best-corrected visual acuity (BCVA)
- IOP
- Slit-lamp exam
- Typically, this is divided into eight stages:
- External structures and adnexa
- Lids and lashes
- Conjunctiva and sclera
- Cornea
- Anterior chamber
- Iris and pupil
- Lens
- Anterior vitreous
- Typically, this is divided into eight stages:
Next up: the results.
Take note: With this 3-year study ongoing, the following data is based on 18-month results.
Overall: SpyGlass’s delivery system using sustained-release bimatoprost and the implanted IOL “demonstrated statistically significant improvements in visual outcomes,” according to a clinical abstract.
Talk about these vision improvements.
From the preoperative (preop) baseline range of 20/30 to 20/100, patients’ vision improved to an 18-month postoperative (postop) range of 20/16 to 20/30.
And IOP reduction?
To start, patients’ baseline post-washout IOP was 25.1 ± 2.5 mmHg.
By 18-months postop, IOP was reduced to 14.1 ± 2.6 mmHg (p < 0.0001).
Was there any difference in reduction between each of the three doses?
No—at least, no statistically significant differences were observed.
Plus: By the 18-month follow-up visit, investigators reported that all 23 patients remained off IOP-lowering topical medications (see here for potential examples of these).
There were also no device-related adverse events noted either.
Nice! So what conclusions have investigators come to so far?
Based on these findings, the study authors have noted “promising visual outcomes” resulting from the use of SpyGlass’s delivery system with bimatoprost and IOL implantation.
However, they emphasized that longer-term data is still being collected (through 3 years postop) to gauge “the potential for multi-year durability of both visual outcomes and IOP lowering efficacy.”
What if I want more details on these findings?
If you’re on-site at ASCRS 2025 in Los Angeles, California, this weekend, check out this poster presentation.
- The title: Visual Outcomes of an Intraocular Lens with a Sustained-Release Bimatoprost Implant in Eyes with Open Angle Glaucoma or Ocular Hypertension
- The presenter: Marco A. Robles, MD
- The presentation date: Sunday, April 27 (see here for the time and location)
And how does all this data compare to prior findings?
The company previously released 6-month data from the FIH study in February 2023.
The following was observed across all treatment groups:
- 45% mean IOP reduction
- No additional IOP-lowering therapies
- No significant AEs
Got it. Lastly, what’s next for this platform?
SpyGlass plans to share long-term data from this FIH trial in the coming months.
Meanwhile: The company also expects to make further progress on its ongoing U.S.-based phase 1/2 study currently evaluating the platform’s safety and efficacy, which initiated enrollment in October 2023.
And looking ahead: Phase 3 clinical trials are on the radar as it looks to work closely with the FDA for a potential regulatory approval and eventual commercial launch.