Roche Reports Positive Phase III Data on Eye Drug, FDA Accepts BLA

What happened: Roche reported one-year data from two phase III studies of investigational vamikibart for uveitic macular edema (UME). The FDA accepted its BLA for the drug, with submissions also filed and accepted in the EU, China and Japan. Key numbers: FDA decision expected by July 2027. Why it matters: If approved, vamikibart could become the first non-steroid targeted treatment for UME, offering an option for patients facing risks from existing therapies. Data support rapid and sustained vision gains and reduced macular thickness. Market: -2.8% by next close ($50.10 on Oct 13), -6.6% YTD

Roche reported one-year data from two phase III studies of investigational vamikibart for uveitic macular edema (UME). The FDA accepted its BLA for the drug, with submissions also filed and accepted in the EU, China and Japan.

If approved, vamikibart could become the first non-steroid targeted treatment for UME, offering an option for patients facing risks from existing therapies. Data support rapid and sustained vision gains and reduced macular thickness. Market: -2.8% by next close ($50.10 on Oct 13), -6.6% YTD