Evicenter
P&T meetings

BIM-IOL System

Open-angle glaucoma or ocular hypertension

Manufacturer
SpyGlass Pharma
Regulatory submission
NDA planned for 2028
Launch
Not announced
Last updated
129 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

Limitations of current therapies

24 evidence topics · 15 sources

Summary

Topical therapy depends on daily self-administration. A 2025 meta-analysis of 47 studies (961,000 patients) estimated that 44% of patients on prostaglandin analogs were adherent at year 1 and that persistence fell from 75% at month 6 to 31% at year 3; in a claims cohort of 3,623 patients with diagnosed glaucoma and 1,677 suspects, nearly one half discontinued all topical therapy within 6 months. The AAO guideline cites a study in which nearly 45% of patients took fewer than 75% of prescribed doses despite free medication, dosing aids, and electronic monitoring. In the CIGTS medication arm (307 participants), predicted 8-year mean deviation loss was 0.62 dB with no reported missed doses and 2.23 dB with missed doses at two thirds of visits. Drop instillation is frequently incorrect: 6 of 70 patients (8.57%) instilled drops correctly in one study, and 33.8% of 500 Canadian patients demonstrated improper technique. Ocular surface disease symptoms were reported by 305 of 630 patients (48.4%) using topical therapy, with higher scores as the number of medications increased. Among procedural alternatives, SLT effect may wane and require repetition, MIGS are indicated mainly for mild to moderate disease and are performed routinely by about one third of US cataract surgeons (company estimate), incisional surgery carries higher complication risk, and approved intracameral implants carry corneal endothelial cell loss warnings and administration limits.

Adherence and persistence with prostaglandin analogs: systematic review and meta-analysis

“The SLR included 50 publications reporting on 47 unique studies and involving 961,000 patients.” (opens the source at this quote in a new tab)

“The mean proportion of patients on any/unspecified PGA who were adherent at Year 1 was 44% (95% CI: 31%-58%).” (opens the source at this quote in a new tab)

“The mean proportion of patients on any/unspecified PGA who were persistent fell from 75% (95% CI: 66%-85%) at Month 6 to 31% (95% CI: 12%-55%) at Year 3” (opens the source at this quote in a new tab)

Persistence with topical therapy: US claims cohort

“Nearly one half of the individuals who had filled a glaucoma prescription discontinued all topical ocular hypotensive therapy within six months, and just 37% of these individuals recently had refilled their initial medication at three years after the first dispensing.” (opens the source at this quote in a new tab)

Adherence measured by pharmacy claims: GAPS

“The mean medication possession ratio (MPR) was 0.64 (median 0.57) for the 13,956 subjects. Although 59% potentially had an ocular hypotensive agent at 12 months, only 10% had such medication available continuously.” (opens the source at this quote in a new tab)

AAO Preferred Practice Pattern: adherence and instillation barriers

“Adequate treatment of glaucoma requires a high level of adherence to therapy. Frequently this is not achieved, and studies indicate relatively poor adherence to therapy.” (opens the source at this quote in a new tab)

“Even with instruction, free medication, once-daily administration, use of a dosing aid, and electronic monitoring of adherence, nearly 45% of patients in one study took fewer than 75% of their prescribed doses.” (opens the source at this quote in a new tab)

“Instilling eye drops correctly is difficult for many patients, and their ability to instill them may worsen with aging and comorbidities and as glaucoma progresses.” (opens the source at this quote in a new tab)

Nonadherence and visual field loss: CIGTS medication arm

“Worse medication adherence was associated with loss of MD over time (p=0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval, CI=0.17−1.06; p=0.007); subjects reporting missing medication doses at 1/3 of visits had a loss of 1.42 dB (CI, 0.86−1.98; p<0.0001); subjects reporting missing medication doses at 2/3 of visits had a loss of 2.23 dB (CI, 1.19−3.26; p<0.0001).” (opens the source at this quote in a new tab)

Pharmacy refill adherence, IOP, and structural and functional progression

“A total of 13 670 eyes from 8163 patients were included with a median (interquartile range) PDC of 60 (40.9-77.5). Below the 60% adherence threshold (median), each 10% decrease in PDC was associated with higher mean IOP (β = 0.82 mmHg, P < 0.001)” (opens the source at this quote in a new tab)

Barriers to adherence: cross-sectional survey

“27% of the sample reported poor adherence.” (opens the source at this quote in a new tab)

“Logistic regression analysis, adjusted for age, revealed that the following barriers were associated with higher odds of non-adherence: decreased self-efficacy, OR = 4.7 [95% CI 2.2–9.7, p= < 0.0001]; difficulty instilling drops, OR = 2.3 [95% CI 1.1–4.9, p= 0.03]; forgetfulness, OR = 5.6 [95% CI 2.6–12.1, p= < 0.0001]; and difficulties with the medication schedule, OR = 2.9 [1.4–6.0, p= 0.006].” (opens the source at this quote in a new tab)

Drop instillation errors

“Only 6 patients (8.57%) were able to correctly instill the eye drops (squeeze out 1 drop and instill it into the conjunctival sac without bottle tip contact).” (opens the source at this quote in a new tab)

“Nearly, 9 of 10 glaucoma patients were unable to instill eye drops correctly.” (opens the source at this quote in a new tab)

“500 patients from 10 centers across Canada participated in the study.” (opens the source at this quote in a new tab)

“With regard to drop administration, 6.8% missed their eye and 28.8% contaminated the bottle tip; overall, 33.8% demonstrated improper technique.” (opens the source at this quote in a new tab)

Ocular surface disease with topical therapy

“Overall, 630 patients from 10 sites participated. Of these, 305 patients (48.4%) had an OSDI score indicating either mild (n = 134, 21.3%), moderate (n = 84, 13.3%), or severe (n = 87, 13.8%) OSD symptoms.” (opens the source at this quote in a new tab)

“The severity of OSD symptoms is positively correlated to the number of IOP-lowering medications used.” (opens the source at this quote in a new tab)

“Using Ocular Surface Disease Index for measuring symptoms of dry eye, 60 (59%) patients reported symptoms in at least 1 eye.” (opens the source at this quote in a new tab)

“After adjustment for age and sex, each additional BAK-containing eyedrop was associated with an approximately 2 times higher odds of showing abnormal results on the lissamine green staining test (odds ratio=2.03; 95% confidence interval: 1.06 to 3.89; P=0.034).” (opens the source at this quote in a new tab)

European Glaucoma Society guidelines: preservatives and ocular surface disease

“Preserved topical glaucoma medications may cause and/or exacerbate pre-existing ocular surface disease (OSD), such as dry eye and meibomian gland dysfunction, which have a high prevalence in elderly adults.” (opens the source at this quote in a new tab)

“A possible unwanted effect of long-term BAC use is a reduction in the success rate of filtering surgery.” (opens the source at this quote in a new tab)

Procedural limitations: MIGS uptake and intracameral implants (manufacturer perspective)

“As a result, approximately two-thirds of cataract surgeons in the United States do not perform MIGS procedures routinely despite an estimated 20% of their cataract patients having glaucoma or OHT” (opens the source at this quote in a new tab)

“These implants are placed near the cornea and iris, which can result in corneal endothelial cell loss, inflammation, or other complications.” (opens the source at this quote in a new tab)

Laser trabeculoplasty: waning effect and IOP spikes

“For eyes that have failed to maintain a previously adequate response, repeat ALT has a low long-term rate of success, with failure occurring in nearly 90% of these eyes by 2 years.” (opens the source at this quote in a new tab)

“Intraocular pressure spikes have been noted after SLT in 4.5% to 27% of eyes in various studies” (opens the source at this quote in a new tab)

“that a second 360° SLT procedure may be needed at a later date. [2022]” (opens the source at this quote in a new tab)

Traditional incisional surgery: complication risk

“Traditional glaucoma surgery generally produces greater IOP reduction than MIGS but also has a higher risk of complications.” (opens the source at this quote in a new tab)

Medication possession ratio on prostaglandin analogs relative to the threshold for good adherence

“The mean MPR/PDC of 54% at Year 1 in this review was similar to that reported in Reardon et al (mean MPR/PDC: 56%).” (opens the source at this quote in a new tab)

“Both values (54% and 56%) were below the 80% threshold for good adherence” (opens the source at this quote in a new tab)

Definition of persistence and pattern of decline, including by individual prostaglandin analog

“In the measurement of persistence, persistent patients were defined as those who did not switch or discontinue their therapies, with an allowable refill gap of up to 90 days. Duration of therapy was defined as the period between initial therapy prescription and therapy discontinuation or switch.” (opens the source at this quote in a new tab)

“The estimated persistence rates over time for patients on PGAs in our MA suggest that in real-world settings, persistence among patients initiating PGA monotherapy is likely to substantially decline within three years, with the fastest rates of discontinuation occurring in the first 6 to 12 months.” (opens the source at this quote in a new tab)

“Patients on latanoprost were more likely to be persistent at each of the timepoints analyzed compared with patients on travoprost or bimatoprost.” (opens the source at this quote in a new tab)

“However, the CIs of the persistence rates of patients on travoprost, bimatoprost and latanoprost in this review overlapped substantially, suggesting that differences between the individual PGAs were not statistically or clinically significant.” (opens the source at this quote in a new tab)

Agreement between self-reported adherence and electronically monitored adherence

“Two studies evaluated differences between patient-reported adherence (using the MMAS) and adherence as measured using electronic dose monitoring devices, with both studies reporting low agreement between them. Patients tended to report themselves as more adherent than the objective measures recorded.” (opens the source at this quote in a new tab)

Adherence at three years by drug class in a United States claims cohort

“A total of 3623 patients with diagnosed glaucoma and 1677 patients with suspect glaucoma filled at least one prescription for topical ocular hypotensive agents.” (opens the source at this quote in a new tab)

“With a definition for adherence that allows individuals to intermittently refill prescriptions (which means medications are taken substantially less than prescribed), only 37% of patients had refilled their initially prescribed medication within 60 to 120 days at 3 years after their initial dispensing. Adherence estimates at 3 years ranged from 15% to 58%, depending on drug class.” (opens the source at this quote in a new tab)

Direction of bias in claims-based persistence estimates

“We have assumed a liberal duration for each dispensing on the basis of bottle sizes. It is likely therefore that even the very low estimates of persistence and adherence that we found were overestimations of the true levels.” (opens the source at this quote in a new tab)

“Successful glaucoma surgery or laser treatment may have obviated the need for further topical therapy in some patients, but the occurrence of such treatments was rare in this population (approximately 5% had surgery or laser treatment at any time during the follow-up period) and cannot account for the low persistence estimates that we have observed.” (opens the source at this quote in a new tab)

One-year refill patterns: gaps, restarts, switches, and discontinuation

“Among 10,260 subjects who were followed up for at least 1 year after the index prescription, to measure persistency as a function of gaps between refills, 10% used the originally prescribed prostaglandin without any gaps in refilling the prescription, 8% as monotherapy, and 2% with a second drug added to their regimen.” (opens the source at this quote in a new tab)

“Sixteen percent switched from the index drug to another drug, and 20% discontinued all glaucoma medications without adding, switching, or restarting.” (opens the source at this quote in a new tab)

“More than 55% of the patients who had at least 1 year of follow-up, failed to continuously refill their initial medications for a period and later restarted it.” (opens the source at this quote in a new tab)

“In this study, a survival analysis would have identified 90% as failing to refill medications continuously over the study period.” (opens the source at this quote in a new tab)

Effect of free samples on measured adherence

“One fifth of subjects (20%) reported receiving samples on a regular basis, 57% received samples one or two times, and 23% reported never receiving samples. The mean MPRs for these three groups were 0.62, 0.64, and 0.76, respectively” (opens the source at this quote in a new tab)

Prevalence of noncompliance and of combined noncompliance or improper technique

“Of these, 25.6% reported missing at least 1 drop of medication per week, and 4.2% were unable to accurately describe their medication regimen. The overall proportion of noncompliance was 27.9%.” (opens the source at this quote in a new tab)

“Over 50% of the patients surveyed were either noncompliant or demonstrated improper administration technique.” (opens the source at this quote in a new tab)

Observed instillation technique and waiting interval between medications

“Four hundred and seventy-three patients demonstrated their eye drop administration technique. Of those, 365 (77.2%) were judged to be “on target,” 76 (16.1%) were “awkward,” and 32 (6.8%) “missed the eye,” while 136 (28.8%) patients contaminated the bottle tip.” (opens the source at this quote in a new tab)

“In addition, of the 296 patients who required more than 1 type of medication in the same eye, 26 (8.8%; 95% CI 5.8%–12.6%) reported waiting less than 3 minutes between administrations.” (opens the source at this quote in a new tab)

Reasons for missed doses and receipt of instillation instruction

““Forgetfulness” (35.4%) and “being away from drops” (31.1%) were the most common reasons indicated.” (opens the source at this quote in a new tab)

“In our current study only 19.1% of patients had received instructions on ophthalmic medication administration from their pharmacist” (opens the source at this quote in a new tab)