BIM-IOL System

Primary open-angle glaucoma is a chronic, progressive optic neuropathy with an open anterior chamber angle and no secondary cause of IOP elevation. Ocular hypertension is a consistently elevated IOP, in the United States usually greater than 21 mmHg, without glaucomatous damage. IOP is the only known modifiable risk factor. A 2014 meta-analysis estimated a global glaucoma prevalence of 3.54% in people aged 40 to 80 years, or 76.0 million people in 2020, projected to reach 111.8 million in 2040; a 2026 meta-analysis estimated a global open-angle glaucoma prevalence of 2.8% (80.5 million people aged 40 years or older) in 2024, projected to reach 3.5% (186.6 million) by 2060. In the United States, an estimated 4.22 million people were living with glaucoma in 2022 (2.56% of people aged 40 years or older), 1.49 million with vision-affecting glaucoma, with a prevalence of 3.15% in Black adults compared with 1.42% in White adults. Prevalent POAG was identified in 5.5% to 6.2% of Medicare fee-for-service beneficiaries from 2017 to 2021. The prevalence of ocular hypertension is 4.5% in non-Hispanic White and 3.5% in Latino US adults aged 40 years or older.

The sources disagree on several burden estimates because of differences in scope and case definition. Global counts for 2020 are 76.0 million for all glaucoma types in one meta-analysis and 52.68 million for POAG in the AAO guideline, and a 2026 meta-analysis reports 80.5 million with open-angle glaucoma in 2024. US prevalence was 2.1% (2.9 million people aged 40 years or older) in NHANES 2005 to 2008 and 2.56% (4.22 million, a count that includes adults aged 18 years or older) in the 2022 CDC surveillance estimate. The undiagnosed share was reported as over half of participants with glaucoma in one NHANES analysis and as 78% in another analysis of the same survey cycles.

Untreated disease progresses. In the Ocular Hypertension Treatment Study (1,636 participants), the 5-year cumulative probability of POAG was 4.4% with medication and 9.5% with observation (hazard ratio 0.40), and the 20-year cumulative incidence was 45.6%, although visual field loss occurred in 25.2%. In the Early Manifest Glaucoma Trial, progression occurred in 45% of treated and 62% of untreated participants over a median of 6 years, and progression risk decreased by about 10% with each mmHg of initial IOP reduction. Pressure control does not prevent loss in every eye: in the Advanced Glaucoma Intervention Study, 13.1% to 14.4% of eyes whose IOP was below 18 mmHg at every visit still lost four or more units of visual field. In a Swedish cohort of 592 treated patients, the cumulative incidence of bilateral blindness was 5.5% at 10 years and 13.5% at 20 years, and globally glaucoma accounted for 3.61 million blind people (8.39% of all blindness) in 2020. Glaucoma was associated with falls (hazard ratio 1.38) and fractures (hazard ratio 1.31) in England; the fully adjusted association with mortality was not significant (hazard ratio 1.13). In the OHTS 20-year follow-up, the vision-related quality of life score was 58.5 with bilateral visual field POAG compared with 72.5 without POAG.

Glaucoma and cataract frequently coexist: glaucoma was recorded in 22.1% of 82,246 Medicare fee-for-service cataract surgery claims, and the manufacturer estimates that about 1 million of about 5 million US cataract surgeries in 2025 were performed in patients with glaucoma or ocular hypertension. Glaucoma was associated with incremental annual US health care expenditures of $1,863.17 per patient ($9.2 billion nationally), direct costs ranged from $623 per year in early disease to $2,511 per year in end-stage disease with medications accounting for 24% to 61%, and Medicare spending on prostaglandin analogs increased from $733 million in 2013 to $1.09 billion in 2017.