On 19 October, at the American Academy of Ophthalmology (AAO) 2024 conference in Chicago, Illinois, US, findings were presented from the Phase II study on the safety of a Neurotech Pharmaceuticals’ ciliary neurotrophic factor (CNTF)-secreting NT-501 encapsulated cell therapy implantation in patients with glaucoma for neuroprotection.
The Phase II results were presented by Alexandria M Dominguez, MS, research assistant at the Byers Eye Institute at Stanford University and showed that CNTF-secreting implants were well-tolerated by patients with primary open-angle glaucoma, with no severe adverse events reported. The therapy showed promising potential in maintaining intraocular pressure (IOP) and supporting retinal health, which are crucial in glaucoma management.
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Dominguez explained that IOP remained stable throughout the trial, and there were no significant changes in visual acuity. However, from baseline to month 24, there was a significant increase in retinal nerve fibre layer thickness in the treatment groups compared to the sham group. A similar trend was observed in the ganglion cell complex, with a notable increase in thickness in the two groups that received implants, relative to the sham group. Visual field measurements remained stable throughout the trial, with no significant differences observed between the implant, sham, or crossover groups.
During the subsequent question-and-answer session, questions were raised about where the increase in fibre thickness occurred. Jeffrey Goldberg, MD, PhD, professor, and chair of ophthalmology at the Byers Eye Institute at Stanford University, clarified that much of the thickening happened in areas that had previously thinned in these patients, suggesting the potential to target the regions where retinal ganglion cells are most affected. Since the poles often exhibit more thinning, it is hypothesised that this is where improvement tends to occur. Key opinion leaders (KOLs) interviewed by leading data and analytics company GlobalData highlighted neuroprotective drugs as a critical unmet need in glaucoma treatment. Current therapies focus primarily on lowering and controlling IOP, which is a known risk factor for the onset and progression of glaucoma. However, glaucoma progression ultimately results in axonal damage in the optic nerve, leading to irreversible vision loss and, eventually, blindness. As a result, directly protecting axons, rather than solely targeting elevated IOP, presents a promising alternative treatment approach. With no neuroprotective drugs currently in active clinical development for glaucoma, the NT-501 implant shows particular promise.
The NT-501 implant exhibited a strong safety profile in glaucoma patients, with encouraging structural improvements that suggest active biological effects and potential neuroprotection. The trial has now expanded to include the evaluation of dual implants. To more accurately assess functional efficacy in the trial, the cohort sizes are being increased.
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