Claris Biotherapeutics to Host Virtual KOL Event on Positive CSB-001 Data and the Unmet Need in Limbal Stem Cell Deficiency (LSCD)

San Francisco, Oct. 15, 2026 – Claris Biotherapeutics, Inc., a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where limited or no treatment options exist, today announced it will host a virtual key opinion leader (KOL) event on Thursday, October 22, 2026, at 11:30 AM ET. To register for the event, please click here.

The event will feature John Affeldt, MD, from Loma Linda University Health, a leading expert in limbal stem cell deficiency (LSCD), who will join company management to discuss:

• The unmet need and current treatment landscape for LSCD, a rare blinding disease.
• CSB-001 (oremepermin alfa ophthalmic solution), the Company’s lead investigational therapy intended to target the underlying pathophysiology of LSCD.
• An overview of recent CSB-001 clinical data presented at the American Academy of Ophthalmology (AAO) Annual Meeting on October 11, 2026, highlighting the therapy’s potential to offer the first pharmacological treatment option for patients with LSCD.

A live question-and-answer session will follow the formal presentation.

KOL Event Webcast Details

Claris will host the virtual KOL event on Thursday, October 22, 2026, at 11:30 AM ET. To register for the event, please click here.

About John Affeldt, MD

John Affeldt, MD completed his residency and cornea research fellowship at the Doheny Eye Institute at USC, followed by a clinical fellowship in cornea at the Bascom Palmer Eye Institute in Miami (ranked #5 and #1 by US News & World Report, respectively). He is currently an Associate Professor and the Director of the Dry Eye Center of Excellence at Loma Linda University Eye Institute, and he serves on the Board of Directors of the Professional Alumni Association at the Doheny Eye Institute, UCLA. A dedicated educator, Dr. Affeldt has been named Teacher of the Year at USC and at Loma Linda, and in 2026 he was honored as Distinguished Alumnus of the Year by the Doheny Eye Institute, UCLA.

About LSCD and CSB-001

Limbal stem cell deficiency (LSCD) is a disease of the ocular surface in which specialized epithelial stem cells that continuously replenish and repair the corneal surface are dysfunctional or deficient in number, leading to severe vision loss or blindness. There are no pharmacological options approved for the treatment of LSCD. CSB-001 (oremepermin alfa ophthalmic solution) contains recombinant human deleted hepatocyte growth factor (dHGF) as its active ingredient. By promoting corneal epithelial regeneration while modulating inflammation, inhibiting fibrosis, and promoting cell survival, CSB-001 has the potential to address the underlying pathophysiology of LSCD. Clinical data recently presented at the American Academy of Ophthalmology (AAO) Annual Meeting on October 11, 2026, demonstrate substantial, durable improvements in visual acuity in LSCD patients treated with CSB-001. 

In 1H 2027, Claris plans to initiate two pivotal studies evaluating the safety and efficacy of CSB-001 compared to vehicle in a total of approximately 400 LSCD subjects. The primary efficacy endpoint will be visual acuity supported by anatomical endpoints. Unlike the proof-of-concept study that contained a dosing holiday, the planned pivotal studies will dose continuously. If approved, CSB-001 has the potential to become the first pharmacologic treatment for LSCD, providing an efficacious, safe, accessible, and scalable non-surgical treatment option. 

Estimates indicate that at least 30,000 LSCD patients in the U.S. are actively being managed by an eye care professional, with at least 40% of the patients having bilateral disease, although the true prevalence is likely higher due to incomplete disease recognition and underdiagnosis.

About Claris Bio

Claris Biotherapeutics is a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where no or limited treatment options exist. With an initial focus on limbal stem cell deficiency (LSCD), a blinding disease, we are developing the first pharmacologic treatment with the potential to provide a reliable, accessible, and scalable non-surgical treatment option, while moving medical management beyond today's palliative care and towards meaningful improvements in vision and ocular surface health. Our near-term plan is to advance our lead therapeutic candidate, CSB-001 (oremepermin alfa ophthalmic solution), into LSCD pivotal studies in the first half of 2027, with a longer-term goal to become a leader in developing new therapies that improve vision and change patients’ lives. Foundational intellectual property for Claris was based on the scientific work of Drs. Reza Dana, MD, MSc, MPH, and Sunil Chauhan, DVM, PhD., both from the Massachusetts Eye and Ear and the Harvard Medical School Department of Ophthalmology. To learn more, visit www.clarisbio.com.

Media Contact

Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com