CICLOSPORIN
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Vevye®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- AFT PHARMACEUTICALS (AU) PTY LTD
- Condition/indication:
(therapeutic use) -
- Dry eye disease with keratitis
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- Change to listing (Category 4)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
Lodgement of required documentation: - 15/04/2026
-
Acceptance of complete documentation:
- Accepted
-
6Agreement to listing arrangements:
- Commenced on 19/05/2026
-
Status:
- Under consideration
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended the General Schedule Authority Required (telephone/electronic) listing of ciclosporin eye drops (Vevye) for the treatment of chronic severe dry eye disease with keratitis in adult patients whose condition has not been adequately controlled with an artificial tears substitute. The PBAC’s recommendation for listing was based on, among other matters, its assessment that Vevye should not cost any more than the currently PBS-listed ciclosporin eye drops. The PBAC advised that Vevye should join the existing risk sharing arrangement (RSA) for ciclosporin eye drops and that there should be no increase to the expenditure caps.