Qlaris Bio to Present New Data on QLS-111 for Glaucoma at World Glaucoma Congress

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-23

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Qlaris Bio announced that new clinical and preclinical data on its lead investigational compound, QLS-111, will be presented at the 2025 World Glaucoma Congress. This includes data from Phase 2 studies (Osprey and Apteryx) in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT). QLS-111 is a novel, preservative-free ATP-sensitive potassium (KATP) channel opener that lowers intraocular pressure (IOP) by targeting episcleral venous pressure (EVP). Presentations will highlight QLS-111's unique mechanism of action and its additive IOP-lowering effect when combined with latanoprost. The company emphasizes QLS-111's excellent safety profile and potential as a valuable adjunct to existing glaucoma therapies.

Key Highlights

  • New data from Phase 2 studies (Osprey and Apteryx) on QLS-111 will be presented at the 2025 World Glaucoma Congress.
  • QLS-111 is a novel ATP-sensitive potassium channel opener with a unique mechanism of action targeting episcleral venous pressure (EVP).
  • QLS-111 demonstrated significant IOP lowering as monotherapy and adjunctive therapy with latanoprost, with excellent safety and tolerability.
  • QLS-111 is a preservative-free topical eye drop with an excellent safety profile.

Incidence and Prevalence

Global Epidemiology of Glaucoma: Latest Estimates and Prevalence Data

Global Burden and Projections

Glaucoma is the second leading cause of blindness globally, representing a significant public health concern. Currently, more than 60 million people are affected by glaucoma worldwide, with numbers expected to increase as the population ages. By 2040, the number of people affected by glaucoma globally is projected to increase to 111.8 million.

Globally, glaucoma is responsible for approximately 5.2 million blind (15% of the total burden of world blindness).

Prevalence by Glaucoma Type

The worldwide overall prevalence of Primary Open-Angle Glaucoma (POAG) was 2.4% (95% CI 2.0-2.8%) according to a meta-analysis of 50 publications with 198,259 subjects published between 2000-2020. The current estimated global population of POAG is 68.56 million (95% CI 59.99-79.98).

Primary open-angle glaucoma predominates globally and is the most prevalent type, with significant incidence in the elderly over 70 years of age, irrespective of sex. POAG prevalence increases with age, and men are more susceptible to POAG than women (RR 1.28, p<0.01).

In Asia, the pooled overall glaucoma prevalence in 2013 was 3.54% (95% credible interval 1.83 to 6.28), with Primary open-angle glaucoma (POAG) predominating over primary angle closure glaucoma (PACG) with prevalence rates of 2.34% and 0.73% respectively.

Regional Prevalence Data

Africa has the highest prevalence of POAG (4.0%) among all continents.

In South Central Asia, there will be the steepest increase in number of glaucoma individuals from 17.06 million to 32.90 million between 2013 and 2040 compared with other Asian subregions.

In the United States, the estimated overall prevalence of glaucoma in the population 40 years of age and older was 2.1% (95% confidence interval 1.7%-2.6%), affecting 2.9 million individuals, including 1.4 million women, 1.5 million men, and 2.3 million people 60 years of age and older. The number of people affected by primary open-angle glaucoma in the US is expected to reach 3.3 million by 2020.

In Saudi Arabia (Riyadh Governorate), the prevalence of glaucoma was 5.6% with males having a significantly higher prevalence (7.62%) than females (3.48%).

In Colombia, the average incidence of glaucoma was 17.36 per 1,000 inhabitants, increasing from 12.29 in 2015 to 24.22 in 2019.

In a Thai population study, the overall prevalence of glaucoma was 6.1% (128/2092). The percentages of primary open angle glaucoma, primary angle closure glaucoma, normotension glaucoma and secondary glaucoma were 47.7%, 41.4%, 9.4%, and 1.6% respectively.

In a Kenyan teleglaucoma program, the prevalence of glaucoma was 3.46% (n=42) and glaucoma suspects was 4.12% (n=50).

In central India (Rajnandangaon district), the age-sex standardized prevalence of glaucoma was 3.68% (95% CI 3.27 to 4.07). The proportion of open angle, closed angle, secondary glaucoma, ocular hypertension and glaucoma suspects was 13.1%, 21.2%, 21.2%, 14.5% and 30% respectively.

Risk Factors

Obstructive sleep apnea (OSA) was identified as a risk factor for glaucoma with an odds ratio of 2.46 (95% CI, 1.32-4.59) in case-control studies and 1.43 (95% CI, 1.21-1.69) in cohort studies. In Taiwan, OSA is associated with an increased risk of subsequent open-angle glaucoma diagnosis (hazard ratio 1.67, 95% CI 1.30-2.17, P<0.001).

The prevalence of glaucoma was higher in a group of older adults with dementia of the Alzheimer's type (DAT) (9.5%) than in a comparable control group (4.1%).

Awareness

Awareness of glaucoma diagnosis is low globally - in Saudi Arabia, only 23.5% of glaucoma patients were aware of their diagnosis, while in the US, over half of participants with glaucoma were unaware they had the disease.

Drug used in other indications

Based on the provided context, there is insufficient information to address the queries about QLS-111's indications beyond glaucoma and the intervention models for these trials. The context does not contain specific information about QLS-111 clinical trials, indications, or intervention models.

Risk Factors and Comorbidities

Risk Factors and Comorbidities for Glaucoma

Top Risk Factors for Glaucoma

Based on the available information, the most significant risk factors for glaucoma include:

  1. Elevated intraocular pressure (IOP) is consistently identified as a major risk factor for open-angle glaucoma development. Studies show that even a 1 mm Hg increase in baseline IOP is associated with higher glaucoma risk. IOP is an important risk factor in the development of ocular hypertension (OHT) to the onset of POAG or POAG progress.

  2. Older age has been consistently associated with the development of open-angle glaucoma in individuals with healthy eyes and is also a prognostic factor for glaucoma progression.

  3. Family history for open-angle glaucoma may be associated with the development of the disease, suggesting a genetic component.

  4. Thinner central corneal thickness (CCT) is a predictive factor for the development of open-angle glaucoma in individuals with ocular hypertension and a prognostic factor for glaucoma progression.

Significant Comorbidities

Several systemic conditions show strong associations with glaucoma:

  1. Obstructive Sleep Apnea (OSA) has been identified as a significant risk factor for glaucoma. Meta-analysis showed OSA was associated with glaucoma (OR=2.46 for case-control studies; OR=1.43 for cohort studies). One study found 20.5% of OSA patients had glaucoma, with 75% having normal-tension glaucoma. Severe OSA showed higher glaucoma prevalence (25.9%) compared to moderate OSA (8.3%).

  2. Diabetes has been found to have a significant positive association with chronic open-angle glaucoma and may be associated with glaucoma progression. Diabetes may act as an IOP-independent risk factor for early progression of glaucoma by promoting oxidative stress and inflammation-mediated RGC dysfunction.

  3. Systemic hypertension and its treatment have shown associations with glaucoma. A systolic blood pressure/intraocular pressure (BP/IOP) ratio less than 5.75 and taking medication for systemic hypertension were found to have significant positive associations with glaucoma. Systolic blood pressure (SBP) is strongly associated with both socioeconomic status and IOP.

Additional Risk Factors

Other factors that may influence glaucoma risk include:

  • Trans-lamina cribrosa pressure difference (TLCPD), the difference between IOP and orbital cerebrospinal fluid pressure (CSF-P), has been investigated as a possible risk factor. Increased TLCPD has been associated with decreased neuroretinal rim area and increased visual field defects.

  • Lower cerebrospinal fluid pressure (CSF-P) in the setting of normal IOP has been implicated as a potential risk factor for normal tension glaucoma.

  • Body mass index (BMI) may have a protective effect, as increased BMI is associated with decreased prevalence of glaucoma, possibly due to increased CSF-P.

  • Genetic factors play a role in glaucoma risk. Studies have identified specific genetic variants associated with glaucoma, including those in the LDB2, CDKN2B, ABO, PDE3A, and CDH13 genes. Individuals with a high polygenetic-risk score (PRS) showed 3.02 times higher glaucoma risk compared to those with low PRS.

  • Dietary factors may modify genetic risk. High carbohydrate intake (≥70%) increased glaucoma risk by 3.74 times in those with high PRS compared to low PRS. Good control of serum glucose concentrations and blood pressure with a balanced diet may reduce glaucoma risk.

  • Low ocular perfusion pressure and nocturnal IOP fluctuation are also important factors, with controlling nocturnal IOP fluctuation being an important measure for the prevention of glaucoma progress.