DOVER, Del. — October 7, 2026
Theialife announced a positive Type C meeting with the U.S. Food and Drug Administration (FDA) regarding ND10, its investigational oral therapy for progressive myopia in children. The meeting established alignment on key elements of the proposed pivotal development program, including study design, efficacy endpoints and treatment duration. The regulatory discussion provides the company with a clearer path toward advancing ND10 into Phase 3 clinical development, targeting an unmet need for treatments that can slow the progression of childhood myopia rather than solely correct refractive error.
ORBIS 1 and ORBIS 2 to Evaluate ND10
The planned global Phase 3 program comprises two clinical trials, ORBIS 1 and ORBIS 2, designed to assess the efficacy and safety of ND10 compared with placebo in eligible pediatric patients with progressive myopia. Participants are expected to be randomized to receive ND10 extended-release capsules or placebo, while both groups continue using single-vision corrective lenses. The primary efficacy endpoint will measure the treatment’s effect on myopia progression, with secondary endpoints evaluating additional progression-related and ocular measures. The program will also include follow-up after treatment to assess the durability of potential benefits and the possibility of rebound progression after treatment cessation. An interim efficacy analysis is planned as part of the development program.
Oral Disease-Modifying Approach Targets Childhood Myopia
ND10, also known as 7-methylxanthine, is being developed as a twice-daily oral, extended-release therapy intended to slow progressive myopia in children. Theialife aims to offer an alternative approach alongside existing myopia-management interventions, with the goal of reducing the risk associated with worsening nearsightedness. Progressive myopia can lead to high myopia, which is associated with an increased risk of serious eye complications later in life, including retinal detachment and myopic macular complications. The planned clinical program will be led by Rupa Wong, M.D., a board-certified pediatric ophthalmologist at Honolulu Eye Clinic. ND10 remains investigational, and its safety and efficacy for slowing myopia progression have not yet been established through the planned pivotal trials.
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Phase 3 Studies Targeted to Begin in 2027
Following its FDA meeting, Theialife plans to finalize preparations for ORBIS 1 and ORBIS 2, with initiation targeted for the first half of 2027. This timeline remains subject to acceptance of the Investigational New Drug (IND) application and successful completion of the company’s ongoing Series A financing. Theialife describes ND10 as its lead clinical asset and is also developing a broader ophthalmology pipeline targeting conditions involving retinal fibrosis, meibomian gland fibrosis, trabecular meshwork fibrosis and corneal blindness. The planned Phase 3 program represents a key development milestone for the company as it works to evaluate whether an oral therapy can provide a disease-modifying option for children with progressive myopia.
Source::Theialife, press release
