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news.NT-501, substantially slows the loss of vision
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Neurotech Pharmaceuticals, a biotechnology company, has announced that the company’s lead product candidate, NT-501, substantially slowed the loss of vision in a Phase II clinical trial in subjects with dry age-related macular degeneration involving geographic atrophy.
In the study, the high dose of NT-501 stabilized best corrected visual acuity (BCVA) at 12 months, with 96.3% (p=0.078) of treated patients losing fewer than three lines of vision, or 15 letters, versus 75% of the patients in the sham-treatment group, the company said.
The Phase II study is a multi-centered, randomized, double-masked, sham-controlled study of 51 subjects with geographic atrophy. Patients received either a high or low dose NT-501 implant or a sham treatment in one eye only and were assessed for changes in BCVA.
BCVA was measured by an electronic visual acuity tester using the early treatment diabetic retinopathy study protocol. Patients were also evaluated for an increase in BCVA. However, no increase was observed, likely due to existing photoreceptor damage, said Neurotech.
The strong trend in visual acuity stabilization at 12 months was preceded by a dose-dependent, statistically significant increase in retinal thickness as measured by optical coherence tomography that was observed as early as four months post-implantation. The observed structural change is consistent with preclinical studies of NT-501 in which ciliary neurotrophic factor was shown to increase the thickness of the retina and the outer nuclear layer of photoreceptors responsible for vision, added Neurotech. This increase in retinal thickness may be responsible for photoreceptor rescue and protection as observed in numerous animal models of retinal degeneration.
Ted Danse, president and CEO of Neurotech, said: We believe the anatomical changes observed in patients treated with NT-501 have led to the emergence of a clinically meaningful visual acuity benefit for patients with geographic atrophy. NT-501 may provide a much needed treatment option for these patients and we intend to discuss these data and a pivotal trial design with the FDA.