Shots:
- EyeYon Medical secured FDA IDE approval to initiate the first US clinical study of EndoArt, a synthetic endothelial layer and an FDA-designated Breakthrough Device for chronic corneal edema
- The study will involve 10+ leading US cornea surgeons, evaluating EndoArt as a novel alternative for patients unsuitable for human tissue implantation
- EndoArt has already seen rapid adoption in Europe and has received CE mark. Additionally, showed successful clinical progress in China, and up to seven years of data with 800+ EndoArt implantations demonstrated long-term safety, clarity, and durable therapeutic benefit
Ref: PR Newswire | Image: EyeYon Medical | Press Release
Related News: The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)
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