SGP-SPEC-001

25 evidence topics · 3 sources

Objective

Registered study purpose

“The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination.” (opens the source at this quote in a new tab)

Publication aim

“This study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).” (opens the source at this quote in a new tab)
“A placebo arm was not included because the current study was designed as a pilot to help guide dose selection for future research.” (opens the source at this quote in a new tab)

Location and study date

Study dates and site

Field	Registry record
Study start (actual)	“2022-04-21”
Primary completion (actual)	“2022-12-13”
Study completion (actual)	“2022-12-13”
First submitted	“2025-08-22”
Facility	“Centro Oftalmológico Robles”
City	“Santa Rosa de Copán”
Country	“Honduras”

Enrollment period and ethics approval

“The first patient was consented in April 2022, and the completion date of this initial pilot was December 2022.” (opens the source at this quote in a new tab)
“This nonrandomized, prospective, proof-of-concept interventional study was approved by the National Health Research Ethics Committee in El Salvador (CNEIS/2022/01H).” (opens the source at this quote in a new tab)

Study design

Registered design

“This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model.” (opens the source at this quote in a new tab)
“There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation.” (opens the source at this quote in a new tab)

Design element	Registry record
Phase	“Not Applicable”
Allocation	“Non-Randomized”
Intervention model	“Parallel Assignment”
Masking	“Single”
Masked roles	“Outcomes Assessor”

Allocation and masking as published

“Participants were sequentially assigned by the local investigator (author MR) to receive either the low configuration (75 μg bimatoprost), medium configuration (150 μg), or high configuration (300 μg) of the product in a 1:1:1 allocation ratio. Neither subjects nor investigators were masked to assignments. Only one eye per subject was designated for treatment in the study.” (opens the source at this quote in a new tab)

Eligibility criteria

Key inclusion criteria

Criterion	Quoted publication text
Age	“Male or female subjects at least 22 years of age”
Cataract	“Age-related cataract eligible for phacoemulsification, with BCDVA 20/30 or worse”
Medicated IOP	“Screening IOP ≤ 24 mmHg while on at least a prostaglandin analogue, with a stable medication regimen for ≥ 4 weeks”
Post-washout IOP	“Baseline unmedicated (post-washout) IOP ≥ 22 mmHg and ≤ 36 mmHg, and at least 3 mmHg higher than medicated screening IOP”
Optic disc	“Screening cup-to-disc ratio of 0.8 or less”
Angle anatomy	“Normal open-angle anatomy (Shaffer grade ≥ 2) by gonioscopy”

Key exclusion criteria

Criterion	Quoted publication text
Secondary glaucoma	“Pseudoexfoliation, pigmentary, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders”
Endothelium	“Central corneal endothelial cell count < 2000 cells/mm2 by specular microscopy”
Prior procedures	“History of incisional glaucoma surgery, argon laser trabeculoplasty, iridectomy, or iridotomy, or completion of selective laser trabeculoplasty within 90 days before screening”
Inflammation	“History of uveitis/iritis”
Macula	“History of macular edema”
IOL power	“Inability to receive an IOL ranging from 19 to 25 D”
Alpha-blockers	“Use of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) or similar medications”
Diabetic eye disease	“Diabetic retinopathy or diabetic maculopathy”
Hypersensitivity	“Subjects with known hypersensitivity or allergy to bimatoprost ophthalmic eye drops”

Prior prostaglandin response requirement

“All subjects were required to have responded to topical prostaglandin analogues.” (opens the source at this quote in a new tab)

Treatment

Implant configuration and surgical procedure

“The studied drug delivery system consists of two silicone molded pads attached to an IOL (defined as the bimatoprost implant system). Each pad sits at the optic–haptic junction, contains a multiyear bimatoprost load, and delivers slow, continuous elution of bimatoprost with a near-zero-order delivery profile. Studied drug content selections include 75 μg, 150 μg, and 300 μg of bimatoprost.” (opens the source at this quote in a new tab)
“The postoperative regimen included a weekly taper of topical steroid/antibiotic combination from Q4H to Q6H to Q8H over a 3-week period. IOP-lowering drops were not reintroduced unless clinically necessary.” (opens the source at this quote in a new tab)

Relative daily release by dose

“Enrolled patients were sequentially assigned 1:1:1 into three groups, where patients received a BIM-IOL System containing 75, 150 or 300 mcg of bimatoprost that continuously released a low (1x), mid (2x) or high (4x) dose of bimatoprost per day, respectively.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using the proportion of unmedicated eyes with IOP reduction of 20% or more at month 6 as the primary endpoint

Registered primary and secondary outcomes

Outcome type	Measure	Time frame
Primary	“Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6”	“From Baseline until the end of post-operative follow-up at Month 6”
Secondary	“Mean change in unmedicated IOP from Baseline to Month 6”	“From Baseline until the end of post-operative follow-up at Month 6”
Secondary	“Number of topical glaucoma medications”	“From Screening until the end of post-operative follow-up at Month 6”
Other	“Adverse Events”	“From Screening to the end of post-operative follow-up at Month 6”
Other	“Supplementary Safety Parameter - Specular Microscopy”	“From Baseline until the end of post-operative follow-up at Month 6”

Primary endpoint as published

“The primary endpoint was the proportion of unmedicated eyes with IOP reduction > 20% from baseline at month 6 and onward. Secondary outcomes included adverse events, mean changes in IOP, and mean changes in glaucoma medications.” (opens the source at this quote in a new tab)

Rationale for the 20% IOP reduction threshold

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

Planned and enrolled participants

“The enrollment target was set at up to 30 subjects. Sample size was not calculated to attain pre-determined power for specified assumptions and type I error. Instead, the sample size was determined on the basis of ethical considerations, to adequately characterize safety across the three doses, and to obtain initial estimates of mean change-from-baseline IOPs with corresponding standard deviations.” (opens the source at this quote in a new tab)

Enrollment type	Participants
Actual	“24”

Description of analysis sets

Analysis populations and significance threshold

“The statistical significance threshold was set at p < 0.05. Data were analyzed both on a per-protocol basis and with intention-to-treat analysis, by a trained statistician.” (opens the source at this quote in a new tab)
“When compared to the intention-to-treat IOP analysis through 6 months, outcomes were similar (Supplemental Table 2).” (opens the source at this quote in a new tab)

Results

Participant disposition

Screening, enrollment, and protocol deviation

“A total of 29 subjects were consented for the study from April through June 2022 (Fig. 2). Of those, four subjects failed either inclusion or exclusion criteria prior to surgery, and one withdrew consent prior to any study procedures being performed. The remaining 24 enrollees all received surgical interventions corresponding to their sequential assignments. Eight subjects per group received the low, medium, and high dose implants.” (opens the source at this quote in a new tab)
“No enrollees dropped out during the first 6 months of follow-up. At month 3 it was discovered that a single subject in the high dose implant cohort had preexisting diabetic retinopathy. This subject should have failed eligibility criteria prior to surgery (Table 1) but was followed for safety until referral to the retina clinic.” (opens the source at this quote in a new tab)

Baseline characteristics

Baseline characteristics as published

“Mean age was 70.5 ± 9.6 years, with a near-equal gender ratio. All subjects were of Hispanic/Latino ethnicity and Caucasian race, and all were diagnosed with primary open-angle glaucoma (POAG) with a mean vertical cup-to-disc ratio of 0.6 ± 0.2. Median BCDVA prior to cataract surgery was 20/50.” (opens the source at this quote in a new tab)
“Target pressures for most subjects were achieved preoperatively on a single ocular hypotensive agent (n = 20, 87.0%), while the remainder required two or three. Prior to medication washout, mean IOP was 16.5 ± 3.5 mmHg. Post-washout mean IOP was 25.1 ± 2.5 mmHg.” (opens the source at this quote in a new tab)

Efficacy results

Primary endpoint at month 6

“By week 1, all groups achieved mean IOP reductions exceeding 40% (p < 0.05 all).” (opens the source at this quote in a new tab)
“At month 6, every individual study eye achieved an unmedicated IOP reduction ≥ 20% versus baseline.” (opens the source at this quote in a new tab)

IOP at months 3 and 6 by dose cohort (per-protocol)

Cohort	Baseline IOP, mean mmHg ± SD	Month 3 IOP, mean mmHg ± SD	Month 6 IOP, mean mmHg ± SD	Month 3 % reduction	Month 6 % reduction
75 μg (n = 8)	“24.6 ± 2.1”	“12.4 ± 1.9”	“12.7 ± 2.5”	“49.3 ± 7.2”	“48.4 ± 9.3”
150 μg (n = 8)	“25.6 ± 3.3”	“13.9 ± 2.7”	“14.4 ± 3.2”	“45.5 ± 9.8”	“43.2 ± 12.3”
300 μg (n = 7)	“25.0 ± 1.8”	“14.3 ± 2.4”	“14.3 ± 3.0”	“42.8 ± 9.2”	“42.8 ± 11.9”
Overall (n = 23)	“25.1 ± 2.5”	“13.5 ± 2.4”	“13.8 ± 2.9”	“46.0 ± 8.8”	“44.9 ± 11.0”

Change from baseline and between-cohort comparison at months 3 and 6

Measure	Month 3	Month 6
Overall CFB IOP, mean mmHg ± SD	“− 11.6 ± 2.8”	“− 11.3 ± 3.1”
p value (CFB = 0)	“< 0.0001”	“< 0.0001”
p value (CFB among Tx)	“0.65”	“0.72”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Intraoperative and early postoperative findings

“All procedures were uncomplicated except for a single subject in the low dose cohort who experienced mild iris prolapse into the main incision after anterior chamber overinflation; the iris appearance had normalized without sequelae on scheduled follow-up.” (opens the source at this quote in a new tab)
“Regarding postoperative changes, mild corneal edema was noted in 13 study eyes at day 1 (56.5%). This decreased to a single eye (4.3%) by week 1. At all subsequent visits, no corneal edema was reported.” (opens the source at this quote in a new tab)
“At postoperative month 1, only two subjects (8.7%) had faint anterior chamber cells in their study eyes; all other study eyes were clear.” (opens the source at this quote in a new tab)

Transient visual acuity loss at month 1

“Temporary loss of ≥ 2 Snellen lines occurred in the study eyes of three subjects, each at the month 1 visit. Two were attributed to ocular surface disease and responded to topical drops by subsequent visits.” (opens the source at this quote in a new tab)
“The third instance had no associated ocular findings and self-resolved by the next visit.” (opens the source at this quote in a new tab)

Early postoperative IOP spikes

“Further, no eye had an early postoperative IOP spike that required the addition of medication.” (opens the source at this quote in a new tab)

Study limitations

Summary

SGP-SPEC-001 was a 6-month, single-site, nonrandomized, unmasked dose-exploration pilot in 24 participants, registered on ClinicalTrials.gov in August to September 2025, almost 3 years after its December 2022 completion. The authors did not calculate sample size for statistical power, and one enrolled participant with preexisting diabetic retinopathy should have been excluded before surgery. Only prior responders to topical prostaglandin analogs were eligible, all participants had primary open-angle glaucoma (none had ocular hypertension), and the IOL power range was limited to 19.0 to 25.0 D. No dose-response relationship was observed: month-6 IOP change did not differ among cohorts (p = 0.72), and the doses tested (75, 150, 300 μg) are not the Phase 3 dose (78 mcg). The registry describes the trial as "controlled," although no control group was enrolled.

Limitations stated by the authors

“A small, nonrandomized sample with no control group greatly limits validity and may have contributed to underestimation of adverse effects.” (opens the source at this quote in a new tab)
“The single-site design with a sample comprised entirely of white Latino patients with POAG further limits generalizability to wider populations. Procedures were performed by a single ophthalmologist; given that cataract surgery approaches vary, other operators may realize challenges with a new product.” (opens the source at this quote in a new tab)
“Most subjects required only a single glaucoma medication prior to washout; as such, it is less clear how this product would perform for more recalcitrant glaucomas.” (opens the source at this quote in a new tab)