Neurotech Submits FDA Application for Macular Telangiectasia Cell Therapy

Neurotech Pharmaceuticals submits license application to FDA for NT-501, an encapsulated cell therapy for macular telangiectasia. The submission is based on statistically significant results from phase 3 registration studies showing NT-501 slowed disease progression.

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Aqsa Younas Rana
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Neurotech Submits FDA Application for Macular Telangiectasia Cell Therapy

Neurotech Submits FDA Application for Macular Telangiectasia Cell Therapy

Neurotech Pharmaceuticals, a biotech company, has submitted a license application to the US Food and Drug Administration (FDA) for NT-501, an encapsulated cell therapy for macular telangiectasia, a disease affecting the retina. The submission is based on statistically significant results from phase 3 registration studies showing NT-501 slowed disease progression.

Why this matters: This breakthrough in treating macular telangiectasia offers hope to patients suffering from this debilitating eye disease, which can lead to vision loss and blindness. If approved, NT-501 could pave the way for new treatments for other retinal disorders, improving the lives of millions of people worldwide.

Richard Small, CEO of Neurotech Pharmaceuticals, announced the submission during an update on NT-501 at the Retina World Congress in Fort Lauderdale, Florida. NT-501 is a genetically modified therapeutic factor that delivers ciliary neurotrophic factor (CNTF) to the back of the eye. "By delivering [CNTF] over a long period of time, we keep the photoreceptors healthy, and thus slow down the progression of the disease," Small explained.

Two phase 3 registration studies have demonstrated the efficacy of NT-501 in treating macular telangiectasia. The studies showed statistically significant results in slowing the progression of the disease with the encapsulated cell therapy approach.

Macular telangiectasia is a rare disease that causes progressive damage to the macula, the central part of the retina responsible for sharp, central vision. It can lead to vision loss and blindness. There are currently no FDA-approved treatments for the condition.

The FDA submission marks a significant milestone for Neurotech Pharmaceuticals and offers hope to patients suffering from macular telangiectasia. If approved, NT-501 would become the first available treatment for slowing the progression of this debilitating eye disease. The novel encapsulated cell therapy approach delivers therapeutic factors directly to the retina in a sustained manner, providing a potential new paradigm for treating retinal disorders.