Theialife Announces Positive Type C Meeting with FDA for ND10 in Progressive Myopia

Company and Agency align on pivotal program design, endpoint strategy and study duration, providing clear path forward for ND10 development

Global Phase 3 program to evaluate potential of ND10 extended-release formulation to slow myopia progression in children

DOVER, Del., Oct. 07, 2026 (GLOBE NEWSWIRE) -- Theialife, a clinical-stage ophthalmology company developing innovative therapies for ocular diseases, today announced the completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding ND10, its investigational oral, disease-modifying therapy for progressive pediatric myopia.

Following alignment with the FDA on key elements of the proposed pivotal program, Theialife has a clear path to advance ND10 to Phase 3 clinical development. This alignment marks an important step in the Company’s efforts to bring a new treatment option to children with progressive myopia.

Key elements of the planned Phase 3 program include:

• Two planned clinical trials, ORBIS 1 and ORBIS 2, designed to evaluate the efficacy and safety of ND10 compared with placebo
• Each trial is expected to 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
• Secondary efficacy endpoints will further characterize 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. of the Honolulu Eye Clinic. Dr. Wong is a Board-certified pediatric ophthalmologist and nationally recognized expert in myopia management.

“Myopia is a growing global health challenge, with prevalence continuing to rise among children worldwide. This progressive form of the disease often leads to high myopia, which in adulthood can be catastrophic for quality of life, productivity, and for downstream conditions including retina detachment, CNV, early cataract formation and a host of other conditions. Given societal trends, with a dramatic rise in screen time among young children, we believe that the burden of progressive myopia will continue to increase for future generations unless an effective therapeutic intervention is developed. There remains a significant need for treatment options that can slow disease progression while fitting into the daily lives of children and their families, versus current approaches that are designed to manage symptoms without addressing the root cause. We believe that ND10 has the potential to be that solution,” said Tom Ruggia, Chief Executive Officer of Theialife. “Our successful meeting with the FDA reflects their clear understanding of the unmet need among these patients and represents an important step forward for both ND10 and our Company. With regulatory alignment on the key elements of our pivotal studies in place, we have clarity on the path ahead as we prepare to advance ND10 into its next stage of clinical development.”

“I'm excited about the prospect of an oral option to slow myopia in kids,” added Dr. Wong.   “ND10 has the potential to become another tool in my arsenal for preventing the future vision threatening consequences of myopia, and I look forward to being a part of this important clinical evaluation.

ND10 is being developed as a twice-daily oral, disease-modifying therapy for progressive myopia, with the potential to provide children and families with a new approach to slowing myopia progression beyond existing interventions.

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

About Theialife:
Theialife is a US-based ophthalmology-focused biopharmaceutical company advancing first-in-class therapies that aim 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. For more information, please visit https://www.theialife.com/ and follow Theialife on LinkedIn.

Investor Relations Contacts for Theialife
Caroline Hubbard/ Lee Roth
Burns McClellan
Chubbard@burnsmc.com / lroth@burnsmc.com