TheiaNova has dosed the first patient in a proof-of-concept clinical study evaluating its investigational eye drop therapy for keratoconus.1

The first-in-class TN-001 eye drop is designed to induce corneal keratocytes to produce new collagen, to prevent further corneal distortion and visual deterioration in keratoconus patients. The drops contain transforming growth factor beta-3 and dexamethasone sodium phosphate.

This first-in-human study will evaluate the safety and ocular tolerability of TN-001 eye drops following topical administration in adult patients with keratoconus. The study is not designed or powered to demonstrate definitive clinical efficacy.

“This milestone marks our transition into patient-based clinical development and reflects the completion of years of preclinical and formulation groundwork,” said Carissa Fonseca, CEO of TheiaNova, which is based in Auckland, New Zealand. “We believe a topical approach is well suited for this indication, and this study will help inform subsequent clinical development.”

The proof-of-concept study follows the review of preclinical safety data and is being conducted at a clinical site in Australia. It is expected to generate data to guide dose selection and future clinical study design. Visit: clinicaltrials.gov.

Reference available at mivision.com.au.