Outlook to conduct another trial for wet AMD drug; Cara strikes new royalty deal

Out­look to con­duct an­oth­er tri­al for eye drug af­ter re­jec­tion: Out­look Ther­a­peu­tics an­nounced Thurs­day that the FDA wants an ad­di­tion­al study as­sess­ing be­va­cizum­ab in wet age-re­lat­ed mac­u­lar de­gen­er­a­tion. The com­pa­ny had re­ceived a com­plete re­sponse let­ter in Au­gust, with the reg­u­la­tor cit­ing “sev­er­al CMC is­sues, open ob­ser­va­tions from pre-ap­proval man­u­fac­tur­ing in­spec­tions and a lack of sub­stan­tial ev­i­dence.” It now plans to re­sub­mit the ap­pli­ca­tion in late 2024, aim­ing for an ap­proval in mid-2025.

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