The FDA is expected to decide on Vamikibart for Uveitic macular edema by July 2027, under a BLA from Genentech (Roche).
What is being decided
Genentech (Roche) has a BLA under FDA review for Vamikibart in Uveitic macular edema. An antibody against interleukin-6 (IL-6), injected into the eye, for swelling of the macula caused by uveitis, the leading cause of moderate and severe vision loss in people with uveitis. Roche says it would be the first non-steroid targeted treatment for the condition, which today is treated mainly with steroids that can cause glaucoma and cataracts. The application rests on 2 identical Phase 3 trials, MEERKAT and SANDCAT, which compared vamikibart injections with a sham procedure; at 52 weeks a numerically higher share of treated patients gained vision, and about two-thirds of eligible patients needed no further injection after week 16. Vamikibart has Orphan Drug designation in the US and EU. Roche disclosed the FDA's acceptance on October 10, 2026 and has said only that it expects a decision by July 2027.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Vamikibart?
Genentech (Roche) expects a decision by July 2027 but has not given an exact date.
Who disclosed it: Genentech (Roche). The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Roche press release, Oct 10 2026
What is Vamikibart being reviewed for?
Genentech (Roche) submitted a BLA for Vamikibart in Uveitic macular edema.
What to know: An antibody against interleukin-6 (IL-6), injected into the eye, for swelling of the macula caused by uveitis, the leading cause of moderate and severe vision loss in people with uveitis. Roche says it would be the first non-steroid targeted treatment for the condition, which today is treated mainly with steroids that can cause glaucoma and cataracts. The application rests on 2 identical Phase 3 trials, MEERKAT and SANDCAT, which compared vamikibart injections with a sham procedure; at 52 weeks a numerically higher share of treated patients gained vision, and about two-thirds of eligible patients needed no further injection after week 16. Vamikibart has Orphan Drug designation in the US and EU. Roche disclosed the FDA's acceptance on October 10, 2026 and has said only that it expects a decision by July 2027.
How much will Vamikibart cost?
Genentech (Roche) has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Vamikibart decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Roche press release, Oct 10 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.