お知らせ • Jun 02
Outlook Therapeutics, Inc. Announces Commercial Launch of LYTENAVA (bevacizumab G gamma) in Germany and the UK for the Treatment of Wet AMD
Outlook Therapeutics, Inc. announced that LYTENAVA (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™? (bevacizum AB gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK. Outlook Therapeutics commenced commercial launch of LYTENAV A™? (bevacIZumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™? is investigational, and a BLA has been resubmitted to the FDA. If approved in the United States, ONS -5010/LYTEN AVA™?, would be the first approved ophthalmic formulation of beVacizumab for use In the United States, ON S-5010/LYTenAVA™?, would be The first approved ophthalmic formulationof bevacizumabfor use in retinal indications, including wet AMD. In some cases, can identify forward-looking statements by terminology such as "anticipate," "believe," "continue," "expect," " may," "plan," "pot potential," "will," or " would" the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, the success of Outlook Therapeutics' commercial launch of LYTenAVA™? in Germany and the UK, Outlook Therapeutics' plans for commercial launch of LYT ENAVA™? in additional countries in the EU, Outlook Therapeutics' commercialization strategy, the market opportunity for ONS-5010/lyTENAVA™?, expectations concerning the therapeutic potential of LYTENAVA®? as a treatment of wet AMD, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, expectations concerning decisions of regulatory bodies and the timing thereof, expectations concerning decisions of Regulatory bodies and the timing thereof, Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics' resources, unanticipated or greater than anticipated impacts or delays due to macroeconomic and geopolitical conditions (including the long-term impacts of ongoing overseas conflicts, tariffs and trade tensions, fluctuations in inflation and interest rates and other economic uncertainty), as well as those risks detailed in Outlook Therapeutics' filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and interest rates, and other economic uncertainty), as and future impacts related to macro economic factors, including as a result, the company has been resubmitted to The company has been resubmitted.