NexThera Completes First Patient Enrollment in U.S. Clinical Trial for ‘NT-101,’ an Eye Drop Treatment for Wet AMD

NexThera Co., Ltd. (CEO:SaeGwang Park) announced on April 9th that it has completed the first patient enrollment for its Phase 1/2a clinical trial of NT-101, a novel eye drop treatment for wet AMD, at a clinical trial site in Pennsylvania on April 8th (U.S. local time).

NT-101 is the first drug candidate developed based on NexThera's innovative eye drop delivery platform technology. This platform enables the targeted delivery of the active drug ingredient to the retinal tissue, located at the innermost part of the eye, thereby offering a safer and more convenient alternative to the conventional intravitreal injection method.

The primary components of NT-101 include intrinsic peptides and carrier proteins, which have demonstrated comparable or superior efficacy compared to existing antibody (or similar antibody) treatments in animal studies. Notably, the action of the carrier proteins enhances the retention of the active ingredient on the ocular surface and significantly improves its delivery to the retinal tissue.

Conventional treatments for wet AMD, particularly anti-VEGF injections, are costly and require intravitreal administration every 2 to 3 months, creating a financial burden and inconvenience for patients. Moreover, there are ongoing concerns about the long-term effectiveness and potential side effects of the treatment. NT-101 offers a balanced modulation of angiogenic factors and inhibitors, achieving a dual mechanism of action that both inhibits angiogenesis and protects optic nerve cells.

This clinical trial will enroll a total of 30 wet AMD patients across four clinics in Maryland, Philadelphia, North Carolina, and Texas. The main goal is to assess the safety and tolerability of NT-101. It will also monitor changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA), which are key indicators of efficacy in wet AMD treatment.

In the clinical trial, patients will receive either a low-dose or high-dose of NT-101 twice daily, in the morning and evening, for 4 weeks. This will be succeeded by a 4-week follow-up, making the total duration 8 weeks.

The principal investigators of this clinical trial are highly experienced professionals with extensive expertise in various ophthalmic diseases, including wet AMD, and considerable experience in conducting clinical trials involving a range of administration routes (eye drops, injections, and oral formulations).

In this early-stage clinical trial of NT-101, NexThera aims to collect crucial data on its therapeutic efficacy and safety, while evaluating its potential to address the limitations of existing injectable therapies. If successful, NT-101 could alleviate the economic burden on patients and provide better treatment outcomes, potentially leading to a significant breakthrough in wet AMD treatment.

NexThera expects this clinical trial to drive transformative advancements in the treatment of wet AMD. The company will remain committed to research and development to offer patients enhanced therapeutic options.

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In this early-stage clinical trial of NT-101, NexThera aims to collect crucial data on its therapeutic efficacy and safety, while evaluating its potential to address the limitations of existing injectable therapies.