Claris Biotherapeutics has closed a $118 million Series B round, which will fund the company through a study beginning next year for its lead candidate, an eye drop designed to treat vision loss caused by limbal stem cell deficiency (LSCD), a rare condition that causes progressive blindness.
The fundraising was co-led by Samsara BioCapital and Catalio Capital Management, along with new and existing investors such as Sofinnova Investments and Novo Holdings.
Based in New Jersey, Claris Bio was founded by ophthalmology experts with the goal of developing disease-modifying therapies for corneal diseases that currently have limited or no treatment options other than surgery.
The company’s scientific platform is built on research originally conducted at Harvard Medical School and Massachusetts Eye and Ear Infirmary.
Claris Bio’s lead candidate, CSB-001, is being developed to treat vision loss caused by LSCD, a disease marked by the progressive loss or dysfunction of the stem cells that maintain and regenerate the outermost layer of the cornea.
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As the disease advances, the cornea becomes increasingly opaque, blurring vision and eventually leading to blindness.
Despite the burden LSCD imposes on daily functioning and quality of life, there are currently no approved drug therapies, and the condition is managed by addressing symptoms, with advanced disease sometimes addressed with complex surgical interventions.
Formulated as an eye drop, CSB-001 is designed to target the underlying causes of LSCD, using a recombinant form of the deleted hepatocyte growth factor (dHGF), a naturally occurring protein involved in tissue repair.
Preliminary data from an ongoing proof-of-concept study in 63 LSCD patients has shown that the therapy promotes the regeneration of the cornea while reducing inflammation and fibrosis, leading to substantial improvements in visual acuity.
Alongside this proof-of-concept study, Claris Bio is conducting a non-interventional study to better understand the natural history of LSCD and identify potential trial sites and participants for its upcoming program.
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The company plans to launch two Phase III studies in the first half of 2027, enrolling about 400 patients to evaluate CSB-001.
If these trials are successful and the drug candidate eventually receives regulatory approval, CSB-001 could become the first non-surgical therapy for LSCD, offering patients a more accessible and reliable treatment option.
“The prospect of significantly improving vision with a convenient eye drop is a tremendous advance,” said Stephen Brady, newly appointed president and CEO of Claris Biotherapeutics.
“The strong interest in CSB-001 reflects both its promise for patients and commercial potential.
With the company financed through Phase III and the team in place to execute, they are ready to advance CSB-001 from a position of strength.
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