Evicenter
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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 treatment

Expected outcomes of therapy

20 evidence topics · 13 sources

Summary

The goal of IOP-lowering therapy is to keep IOP within a target range that preserves optic nerve and visual field status and vision-related quality of life. The AAO guideline sets a reasonable initial goal of a 20% to 30% IOP reduction from baseline; the EGS guideline suggests at least 20% reduction (IOP 18 to 20 mmHg) in early glaucoma and at least 30% (15 to 17 mmHg) in moderate glaucoma. Randomized trials link IOP lowering to slower disease progression: in OHTS (1,636 participants), a 22.5% IOP reduction lowered 5-year conversion to POAG from 9.5% to 4.4% (hazard ratio 0.40); in EMGT (255 participants), a 25% reduction lowered progression from 62% to 45%, with about 10% lower progression risk per mmHg of initial reduction; in UKGTS (516 participants), latanoprost prolonged visual field preservation versus placebo (hazard ratio 0.44); and in AGIS, eyes with IOP below 18 mmHg at all visits had mean visual field change close to zero. For the BIM-IOL System, the phase 3 co-primary endpoints are time-matched mean IOP change from baseline through month 3 and best-corrected distance visual acuity of 20/40 or better. Reported company outcomes are a 34% mean IOP reduction with 98% of evaluable participants free of topical medication at 12 months (78 mcg, phase 1/2) and a 37% mean reduction with 95% drop-free at 36 months (first-in-human, 21 evaluable participants). Visual field preservation has not been reported for the BIM-IOL System.

AAO Preferred Practice Pattern: management goals and target IOP

“The goals of managing patients with POAG are as follows:” (opens the source at this quote in a new tab)

“Control of IOP in the target range” (opens the source at this quote in a new tab)

“Stable optic nerve/circumpapillary RNFL status” (opens the source at this quote in a new tab)

“Stable visual fields” (opens the source at this quote in a new tab)

“Lowering the pretreatment IOP by 25% or more has been shown to slow the progression of POAG.” (opens the source at this quote in a new tab)

European Glaucoma Society guidelines: setting the target IOP

“In early glaucoma, an IOP of 18 to 20 mmHg with a reduction from baseline of at least 20% may be sufficient. In moderate glaucoma, an IOP of 15 to 17 mmHg with a reduction of at least 30% may be required. Lower Target IOP, e.g., 8 to 12 mmHg may be needed in more advanced disease.” (opens the source at this quote in a new tab)

“The goal of glaucoma management is to promote the best possible well-being and quality of life with minimal visual disability caused by glaucoma, within a sustainable health care system. The only approach proven to be effective in preserving visual function is lowering IOP.” (opens the source at this quote in a new tab)

OHTS: prevention of conversion from ocular hypertension to POAG

“During the course of the study, the mean +/- SD reduction in IOP in the medication group was 22.5% +/- 9.9%. The IOP declined by 4.0% +/- 11.6% in the observation group. At 60 months, the cumulative probability of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio, 0.40; 95% confidence interval, 0.27-0.59; P<.0001).” (opens the source at this quote in a new tab)

EMGT: IOP reduction and glaucoma progression

“On average, treatment reduced the IOP by 5.1 mm Hg or 25%, a reduction maintained throughout follow-up. Progression was less frequent in the treatment group (58/129; 45%) than in controls (78/126; 62%) (P =.007) and occurred significantly later in treated patients.” (opens the source at this quote in a new tab)

“In multivariate analyses, progression risk was halved by treatment (HR = 0.50; 95% CI, 0.35-0.71).” (opens the source at this quote in a new tab)

“Progression risk decreased by about 10% with each millimeter of mercury of IOP reduction from baseline to the first follow-up visit (HR = 0.90 per millimeter of mercury decrease; 95% CI, 0.86-0.94).” (opens the source at this quote in a new tab)

EMGT long-term follow-up: immediate versus delayed treatment

“At study end, percentages of eyes with VI or blindness were slightly higher in the treated group than in the untreated control group, 12.1% vs 11.0%, and 9.4.% vs 6.1% respectively, as were subjects with VI in at least one eye, 19.5% vs 18.7%. The differences were not statistically significant, nor were cumulative incidences of VI in at least one eye.” (opens the source at this quote in a new tab)

UKGTS: visual field preservation over 24 months

“Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28-0·69; p=0·0003).” (opens the source at this quote in a new tab)

AGIS: sustained low IOP and visual field stability

“In the Associative Analysis, eyes with 100% of visits with intraocular pressure less than 18 mm Hg over 6 years had mean changes from baseline in visual field defect score close to zero during follow-up, whereas eyes with less than 50% of visits with intraocular pressure less than 18 mm Hg had an estimated worsening over follow-up of 0.63 units of visual field defect score (P =.083).” (opens the source at this quote in a new tab)

LiGHT: 6-year rate of visual field progression with first-line SLT versus drops

“The mean [95% credible interval] MD rate was -0.37 [-0.43 to -0.31] decibels (dB)/year in the drops-first arm and -0.26 [-0.31 to -0.21] dB/year in the SLT-first arm (P = 0.007).” (opens the source at this quote in a new tab)

BIM-IOL System phase 3 endpoints

“The co-primary endpoints are (1) the time-matched mean IOP change from baseline at 8 and 10 a.m. at two and six weeks and three months and (2) BCDVA of 20/40 or better at 12 months. Secondary outcome measures will also be evaluated, including mean IOP, time to postoperative introduction of IOP-lowering medications, and number of IOP-lowering medications introduced postoperatively. Participants will be followed through 36 months, allowing us to compare long-term safety, efficacy, and durability.” (opens the source at this quote in a new tab)

BIM-IOL System reported outcomes to date

“In our FIH trial, evaluable patients who received the BIM-IOL System achieved a mean IOP reduction of 37% compared to baseline, 95% of evaluable patients were off all topical IOP-lowering eye drops, and 100% of evaluable patients achieved 20/30 or better corrected visual acuity, in each case at 36 months.” (opens the source at this quote in a new tab)

“100% of evaluable patients achieved an IOP reduction of more than 20% from baseline and 90.5% (19/21) of evaluable patients maintained an IOP ≤18 mmHg through 36 months.” (opens the source at this quote in a new tab)

“For SpyGlass Pharma’s intended commercial dose of 78-mcg, patients receiving the BIM-IOL System achieved robust clinical improvement:” (opens the source at this quote in a new tab)

“A mean, time-matched IOP reduction from baseline of 34%.” (opens the source at this quote in a new tab)

“98% of evaluable BIM-IOL patients were free from all topical IOP-lowering medications.” (opens the source at this quote in a new tab)

Visual field outcomes with the BIM-IOL System

No evidence found.

Target intraocular pressure and the proportion of visits at which it was met in the Ocular Hypertension Treatment Study

“Participants randomized to medication began treatment to achieve a target IOP of 24 mm Hg or less and a minimum 20% reduction in IOP from the average of the qualifying IOP and IOP at the baseline randomization visit, except that an IOP of less than 18 mm Hg was not required.” (opens the source at this quote in a new tab)

“The IOP goal was met in both eyes at 87% (7515 of 8621) and in one eye at 7% (613 of 8621) of the scheduled follow-up visits completed by medication participants.” (opens the source at this quote in a new tab)

Visual field change per millimeter of mercury of intraocular pressure during early follow-up

“In the adjusted model 2 for all visits there is a predicted worsening in visual field defect score of 0.10 from baseline for each 1 mm Hg increase in average intraocular pressure, a finding that is statistically significant” (opens the source at this quote in a new tab)

“For example, an eye with intraocular pressure greater than 18 mm Hg at seven or more of twelve 6-month visits can expect, on average, a worsening of visual field defect score at 84 months that is approximately two units greater than an eye with intraocular pressure less than 18 mm Hg at each of these twelve 6-month visits” (opens the source at this quote in a new tab)

“A limitation of the present study and of previous studies of the association between intraocular pressure reduction and visual field damage is that the comparison between groups of eyes achieving low and high levels of intraocular pressure is not based on a random allocation.” (opens the source at this quote in a new tab)

Mean intraocular pressure by proportion of visits below 18 mmHg and visual field change through 96 months

“The mean intraocular pressure over the first 6 years of follow-up is 12.3 mm Hg for group A, 14.7 mm Hg for group B, 16.9 mm Hg for group C, and 20.2 mm Hg for group D.” (opens the source at this quote in a new tab)

“For group A (eyes presenting with intraocular pressure less than 18 mm Hg at each visit over 6 years), the mean changes in visual field defect score remain close to zero, whereas in each of the other three groups (B, C, and D), the mean change progressively increases over time to an average worsening in visual field defect score of about two to three points by 96 months” (opens the source at this quote in a new tab)

“Starting at 54 months, mean changes for the four groups diverge and remain consistently ranked according to the percent of visits with intraocular pressure less than 18 mm Hg.” (opens the source at this quote in a new tab)

Visual field loss in eyes maintained below 18 mmHg at every visit

“Although the average change in visual field is close to zero, a proportion of eyes in this group experienced visual field loss despite having intraocular pressure at what is believed to be a safe level.” (opens the source at this quote in a new tab)

“To illustrate, a worsening of four or more units of visual field defect score from baseline was experienced by 13.1% of eyes at 2 years, 13.9% at 5 years, and 14.4% at 7 years.” (opens the source at this quote in a new tab)

Basis for setting an individual target intraocular pressure and the usual size of reduction

“From a pathophysiological and therapeutic point of view, intraocular pressure is the primary modifiable risk factor, since progression of glaucoma usually stops if this pressure is lowered by 30–50% from baseline.” (opens the source at this quote in a new tab)

“The target intraocular pressure for a particular eye is estimated based on the pretreatment intraocular pressure, the severity of damage, presence of risk factors for progression, life expectancy, and potential for adverse effects from treatment.” (opens the source at this quote in a new tab)

“The aim is usually for a reduction in intraocular pressure of 20–50%.” (opens the source at this quote in a new tab)

Rate of visual field progression with immediate versus delayed treatment

“The median rate of progression was –0.14 dB/y slower in the treatment group in the eye with the worse rate (not statistically significant) and –0.10 dB/y slower in the eye with the better rate” (opens the source at this quote in a new tab)

“As opposed to the results in terms of VI, these differences were consistently in favor of the group that received immediate treatment. The treatment group started out with worse MD values than the control group but ended up better.” (opens the source at this quote in a new tab)

UKGTS: proportion of participants with visual field deterioration at 24 months

“59 (25·6%; 95% CI 20·1–31·8) patients in the placebo group reached the deterioration endpoint at 24 months compared with 35 (15·2%; 10·8–20·4) in the latanoprost group (p=0·006).” (opens the source at this quote in a new tab)

Mechanisms proposed for slower visual field progression with drop-independent treatment

“The exact mechanisms for this effect are still unclear and might be related to a more consistent control of IOP, a shorter time to achieve target pressure, and less reliance on patients’ compliance with treatment.” (opens the source at this quote in a new tab)

Visual field outcome reporting in trials of first-line topical medications

“Not a single trial reported a difference or ratio between treatment groups with respect to visual field outcomes, although some trials provided group level data and treatment effect could be calculated based on the group level data.” (opens the source at this quote in a new tab)