๐๐๐ฏ๐๐ซ๐ฎ๐ฆโ๐ฌ ๐๐๐ง๐ ๐๐ก๐๐ซ๐๐ฉ๐ฒ ๐๐จ๐ซ ๐๐๐ญ ๐๐๐ ๐๐๐ซ๐ง๐ฌ ๐ ๐๐โ๐ฌ ๐๐๐๐...
๐๐๐ง๐๐ง๐ญ๐๐๐ก ๐ญ๐จ ๐๐๐ข๐ง๐ญ๐ซ๐จ๐๐ฎ๐๐ ๐๐ฎ๐ฌ๐ฏ๐ข๐ฆ๐จ ๐๐๐ฎ๐ฅ๐๐ซ ๐๐ฆ๐ฉ๐ฅ๐๐ง๐ญ ๐๐จ๐ซ ๐๐๐ญ ๐๐๐
๐Genentech has announced the upcoming reintroduction of Susvimo (ranibizumab injection) 100 mg/mL, designed for intravitreal use via an ocular implant to treat wet age-related macular degeneration (AMD). After a voluntary recall in October 2022 due to performance standard issues discovered during reliability testing, Genentech has made significant updates to the implant and refill needle. These enhancements ensure rigorous performance standards are met, with improvements implemented in manufacturing processes to boost reliability. Retina specialists and their patients in the United States can expect the availability of Susvimo in the coming weeks.
๐๐ฎ๐ญ๐ฅ๐จ๐จ๐ค ๐๐ก๐๐ซ๐๐ฉ๐๐ฎ๐ญ๐ข๐๐ฌ ๐๐๐๐๐ข๐ฏ๐๐ฌ ๐๐ ๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ ๐จ๐ ๐๐ฒ๐ญ๐๐ง๐๐ฏ๐ ๐๐จ๐ซ ๐๐๐ญ ๐๐๐ ๐๐ซ๐๐๐ญ๐ฆ๐๐ง๐ญ
๐ Outlook Therapeutics, Inc. has secured marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Lytenava (bevacizumab gamma), a treatment for wet age-related macular degeneration (AMD). Lytenava is now the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in both the EU and UK. In collaboration with Cencora (formerly AmerisourceBergen), Outlook Therapeutics plans to support the global commercial launch of Lytenava, ensuring efficient distribution and accessibility for patients.
๐๐๐ง๐๐ญ๐๐๐กโ๐ฌ ๐๐๐๐ฒ๐ฌ๐ฆ๐จ ๐๐
๐ ๐๐๐ซ๐ง๐ฌ ๐
๐๐ ๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ฅ ๐๐จ๐ซ ๐๐๐ญ๐ข๐ง๐๐ฅ ๐๐ข๐ฌ๐๐๐ฌ๐๐ฌ
๐งช Genentech, a member of the Roche Group, has received FDA approval for Vabysmo Prefilled Syringe (PFS) for treating three potentially blinding retinal diseases. The Vabysmo 6.0 mg single-dose PFS delivers the same medicine as the previously available Vabysmo vials but in a more convenient, ready-to-use format. The approved indications for Vabysmo include wet AMD, diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This approval represents a significant step forward in providing effective treatments for these serious retinal conditions.
