Theialife Aligns FDA on ND10 for Myopia Progression Study

DOVER, Del., Oct. 07, 2026 /CourierPR/ -- The clinical-stage ophthalmology company Theialife has announced a significant step in the development of its investigational oral therapy ND10, which is designed to address progressive pediatric myopia. The company has completed a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding ND10, aligning on key elements of the proposed pivotal program for Phase 3 clinical development. This alignment marks an important step in Theialife’s efforts to bring a new treatment option to children with progressive myopia.

ND10 is a twice-daily oral therapy that aims to slow myopia progression, a growing global health challenge that often leads to high myopia in adulthood, with severe consequences for quality of life, productivity, and the risk of conditions such as retina detachment, CNV, and early cataract formation.

Theialife and the FDA have agreed on the design of the pivotal program, including two planned clinical trials, ORBIS 1 and ORBIS 2, designed to evaluate the efficacy and safety of ND10 compared to placebo. Each trial will enroll a broad population of pediatric patients with progressive myopia who meet prespecified eligibility criteria. Patients will be randomized to receive ND10 extended-release capsules or placebo during the treatment period, with patients in both groups also wearing single-vision corrective lenses. The primary efficacy endpoint will assess the effect of treatment on myopia progression, with secondary endpoints further characterizing treatment effects on myopia progression and related ocular measures. Patients will be followed after treatment to evaluate the durability of the treatment effect and the potential for rebound following treatment cessation. The planned program includes an interim efficacy analysis.

The clinical program will be led by Rupa Wong, M.D., a Board-certified pediatric ophthalmologist and nationally recognized expert in myopia management. Wong is excited about the prospect of an oral option to slow myopia in children, believing that ND10 has the potential to become another tool in her arsenal for preventing the future vision-threatening consequences of myopia.

Following the Type C meeting, Theialife plans to finalize preparation for the pivotal studies with a goal of initiating both studies in the first half of 2027, subject to the acceptance of the Investigational New Drug (IND) application and the successful completion of its ongoing Series A financing.

Theialife is a US-based ophthalmology-focused biopharmaceutical company advancing first-in-class therapies to address major unmet needs in eye diseases. The Company’s lead asset, ND10 (7-Methylxanthine), is a phase 3-ready oral therapy designed to slow myopia progression. Theialife is building a pipeline of differentiated ophthalmic programs targeting indications that include retinal fibrosis, meibomian gland fibrosis, trabecular meshwork fibrosis, and corneal blindness amongst others. Theialife’s mission is to develop transformative therapies to address significant unmet needs of eyecare practitioners worldwide.

Theialife’s announcement highlights the company’s commitment to addressing a significant unmet need in pediatric ophthalmology. The completion of the Type C meeting with the FDA represents a crucial milestone in the development of ND10, providing Theialife with a clear path forward for advancing the therapy into Phase 3 clinical development. Theialife’s efforts to bring ND10 to market could potentially offer children and families a new approach to slowing myopia progression, a treatment option that is currently not available and could have a substantial impact on the lives of many children with progressive myopia.