바이오스펙테이터

by Sungmin Kim

NexThera announced on May 12 that it has observed a favorable safety profile and early visual acuity improvement signals through the final Clinical Study Report (CSR) from Part 1 of its U.S. Phase 1/2a clinical trial evaluating ‘NT-101,’ an eye-drop treatment candidate for wet age-related macular degeneration (wAMD).

Based on these findings, the company plans to proceed with Part 2 of the study to further evaluate the efficacy of NT-101 in a larger patient population.

NT-101 is an ophthalmic eye-drop formulation combining a peptide derived from pigment epithelium-derived factor (PEDF), an anti-angiogenic factor, with atelocollagen, an excipient that functions as a delivery carrier. According to the company, NT-101 is designed to maintain the balance between pro-angiogenic and anti-angiogenic factors to suppress abnormal blood vessel formation while also providing neuroprotective effects for retinal cells.

Part 1 of the Phase 1/2a study enrolled 20 patients with wAMD who received either low-dose or high-dose NT-101. NexThera reported that patients in the high-dose cohort demonstrated a mean improvement of 6.2 letters in Best-Corrected Visual Acuity (BCVA) at Week 8 compared to baseline.

According to the company, the current standard-of-care intravitreal injection therapy, Eylea® (aflibercept), demonstrated a mean improvement of 5.7 letters at Week 12 in a Phase 2 study, suggesting that NT-101 showed encouraging visual acuity signals relative to historical data from approved injectable therapies.

Regarding safety, NexThera stated that no treatment-related adverse events were identified among any of the 20 patients treated with NT-101.

The company is now advancing into Part 2 of the study, which will enroll 66 patients with wAMD in a placebo-controlled trial designed to further evaluate the efficacy of NT-101. NexThera added that it finalized clinical trial sites in April and is currently conducting Site Initiation Visits (SIVs) at participating institutions.

The current wAMD treatment landscape continues to face unmet medical needs, including patient discomfort, fear, and infection risks associated with repeated intravitreal injections. NexThera is developing NT-101 as a non-invasive eye-drop therapy intended to potentially reduce reliance on injection-based treatments.

“The CSR results suggest the potential of NT-101 as a non-invasive eye-drop treatment option that could complement existing injection-based therapies for wet age-related macular degeneration,” said SaeGwang Park, CEO of NexThera.