BIM-IOL System first-in-human study: no difference across 3 dose arms

“Each treatment arm realized mean IOP reductions from 32.3% to 49.3% over 3 years of follow-up visits. There were no significant intergroup differences.” (opens the source at this quote in a new tab)
“Outcomes were not significantly different between low, medium, and high concentrations of sustained release bimatoprost. One may hypothesize that higher doses would correlate with more substantive IOP-lowering. However, this did not necessarily hold true in the current sample; the greatest IOP reduction from baseline to month 36 was achieved in the 75 μg cohort.” (opens the source at this quote in a new tab)

BIM-IOL System first-in-human study: limits on generalizability to nonresponders and other populations

“All subjects were required to have previously responded to topical prostaglandin analogues. This criterion selected for eyes that would be more likely to benefit from the bimatoprost implant, possibly inflating efficacy metrics. Generalizability to nonresponders is thus limited.” (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.” (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)

BIM-IOL System phase 1/2 trial: results by dose group at 12 months

“Evaluable patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint.” (opens the source at this quote in a new tab)
“98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications.” (opens the source at this quote in a new tab)

Effect of baseline IOP on response to IOP-lowering treatment

“IOP-lowering treatment efficacy depends on untreated IOP, with larger reductions in patients with higher untreated IOP levels.” (opens the source at this quote in a new tab)

“A greater reduction in postoperative IOP occurred in the eyes with the highest preoperative IOP.” (opens the source at this quote in a new tab)

Variation in optic nerve susceptibility and target IOP

“Individuals differ in the susceptibility of their optic nerves to IOP-related damage. A reasonable initial treatment goal in a patient with POAG is to reduce IOP 20% to 30% below baseline and to adjust up or down as indicated by disease course and severity.” (opens the source at this quote in a new tab)

EMGT: treatment effect across subgroups and baseline predictors of progression

“Treatment effects were also evident when stratifying patients by median IOP, mean deviation, and age as well as exfoliation status.” (opens the source at this quote in a new tab)

“Predictive baseline factors were higher intraocular pressure (IOP) (ie, the higher the baseline IOP, the higher the risk), exfoliation, and having both eyes eligible (each of the latter 2 factors doubled the risk), as well as worse mean deviation and older age.” (opens the source at this quote in a new tab)

AGIS: outcome of surgical sequence differed by race

“Surgical outcome varied by race. Black patients did better with laser trabeculoplasty surgery first (30% IOP reduction), whereas White patients did better with trabeculectomy first (48% IOP reduction).” (opens the source at this quote in a new tab)

LiGHT: visual field benefit of first-line SLT by severity

“When stratified by severity, this difference was significant only in mild OAG (P = 0.035, the largest sub-group).” (opens the source at this quote in a new tab)

SLT responsiveness: features of nonresponsive eyes

“A subset of 27 eyes (15.0%) was identified as potentially nonresponsive and found distinctive with older age (mean [SD], 54.1 [12.5] years vs 44.2 [14.2] years; difference, 10.5 years; 95% CI, 2.9 to 18.1; P = .009), higher proportion of female participants (difference, 27.5%; 95% CI, 3.6 to 51.5; P = .03), and lower baseline IOP (difference, -3.2 mm Hg; 95% CI, -5.2 to -1.3; P = .001).” (opens the source at this quote in a new tab)

Subgroup efficacy results for the BIM-IOL System by race, disease severity, glaucoma subtype, or baseline IOP

No evidence found.

Medication-free rate after combined surgery varies with preoperative medication count

“Eyes requiring only a single medication for pressure control before surgery reached a higher rate of drop-free IOP control than eyes receiving multiple drops.” (opens the source at this quote in a new tab)
“Even among eyes receiving maximum preoperative medical therapy (3 or 4 classes of medications), 59% were receiving fewer medications at 5 years, and 48% were completely medication free in the HMS group.” (opens the source at this quote in a new tab)

LiGHT: proportional visual field benefit across baseline severity groups

“This difference was also proportionally similar across the different severity subgroups (∼30% slower in the SLT-first arm) but was only statistically significant for mild OAGs.” (opens the source at this quote in a new tab)

LiGHT: severity mix of the trial population

“The LiGHT Trial population consisted of a large proportion of eyes with OHT and mild OAG for which IOP reduction targets are less stringent than those for more advanced disease.” (opens the source at this quote in a new tab)

UKGTS: severity range and representativeness of the study population

“Furthermore, individuals with advanced open-angle glaucoma were excluded so that the results of the trial only apply to patients with mild to moderate glaucoma.” (opens the source at this quote in a new tab)
“Because consecutive new patients were assessed and recruited for the UKGTS trial, the population studied was representative of the target population considered for treatment and on which the trial results will be applied.” (opens the source at this quote in a new tab)