Theialife said the U.S. Food and Drug Administration has aligned with key elements of the planned Phase 3 development program for ND10, an investigational oral extended-release therapy for progressive pediatric myopia. The company plans to advance 2 pivotal trials, ORBIS 1 and ORBIS 2, with both studies targeted to begin in the first half of 2027, subject to IND acceptance and completion of Series A financing.
The randomized trials will compare ND10 extended-release capsules with placebo in children with progressive myopia, with all participants wearing single-vision corrective lenses. The primary endpoint will assess myopia progression, while secondary endpoints will evaluate additional measures of disease progression and ocular outcomes.
Participants will be followed after treatment to assess the durability of treatment effects and potential rebound after treatment cessation. The program also includes a planned interim efficacy analysis.
ND10 is being developed as a twice-daily oral therapy intended to slow myopia progression in children. The clinical program will be led by Rupa Wong, MD, of the Honolulu Eye Clinic.
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