CiclosporinAPO-CICLOSPORIN
Chronic severe dry eye disease with keratitis in adult patients whose condition has not been adequately controlled by monotherapy with an artificial tears substitute.
Decisions on record
- Meeting Mar 2026 Recommended Dry eye disease with keratitis
- Meeting Mar 2022 Recommended Chronic severe dry eye disease with keratitis
- Meeting Mar 2021 Recommended Dry eye disease with keratitis
Access path
- TGA registered · APO-CICLOSPORIN
TGA label narrower than the PBS population
- Mar 2021Recommended
vs best supportive care (BSC), consisting of preservative-free…
- Mar 2022Recommended · restricted
Comparator changed: best supportive care (BSC), consisting of preservative-free…
- Mar 2026Recommended · restricted
Comparator changed: ciclosporin 0.1% cationic emulsion (Ikervis) → Ikervis and Cequa
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the 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 by monotherapy with an artificial tears substitute.PSD · Mar 2026
6.2 The PBAC noted the consumer input from the National Paediatric Medicines Forum which requested an age agnostic restriction. However, the PBAC noted that neither the submission nor the TGA Clinical Evaluation Report presented data on the use of Vevye in paediatrics. Further, the PBAC noted that the restrictions for Ikervis and Cequa include a clinical criterion stating that “Patient must be at least 18 years of age”.PSD · Mar 2026
5.19 The submission presented a simple cost-minimisation approach based on the ex- manufacturer price of Ikervis and Cequa to determine the price of Vevye (Error! Reference source not found.). The submission did not present equi-effective doses but assumed that the daily dose of Vevye was equivalent to the daily dose of Ikervis or Cequa. The assumed equi-effective doses were:PSD · Mar 2026
1 Leonardi A, et al. Efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trial. Eur JOphthalmol. 2016;26(4):287-296. 7 OFFICIALPSD · Mar 2026
5.17 The submission claimed that compared to Ikervis and Cequa, Vevye offers comparable efficacy in the treatment of the clinical signs of dry eye disease and may provide improved tolerability, with lower rates of instillation-site pain and treatment discontinuation.PSD · Mar 2026
5.18 Noting that no comparative evidence was provided in the submission to support the clinical claim, the PBAC considered that, based on the previous decision that Ikervis was non-inferior to Cequa, it was likely that Vevye was comparable to Ikervis and Cequa in terms of efficacy and safety.PSD · Mar 2026
The PBAC noted and welcomed the input from one health professional and one organisation via the Consumer Comments facility on the PBS website. The health professional described the symptoms related to severe dry eye disease and the quality of life benefits of treatment with ciclosporin for patients with severe disease.PSD · Mar 2021
5.28 There is currently a Risk Sharing Arrangement (RSA) in place for Ikervis and Cequa.PSD · Mar 2026
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a simple cost-minimisation approach based on the ex-manufacturer price of Ikervis and Cequa to determine the price of Vevye. PSD · 2026
Decision context
PopulationAdults with chronic severe dry eye disease with keratitis (corneal fluorescein staining grade ≥4 and OSDI score ≥23) inadequately controlled by monotherapy with preservative-free artificial tears substitute.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | Ikervis and Cequa | — | RCT · tCFS |
| Mar 2022 | Recommended · restricted | ciclosporin 0.1% cationic emulsion (Ikervis) | — | RCT · Surrogate |
| Mar 2021 | Recommended | best supportive care (BSC), consisting of preservative-free artificial tears as needed | $15k–25k | RCT · CFS-OSDI response |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Study 2014 (NCT02254265) | Ph 2, PHASE3 | 455 | Conjunctival Staining | completed |
| Study 2016 (NCT02688556) | Ph 3 | 745 | Tear Production | completed |
Consumer voice
A health professional and Optometry Australia provided input on ciclosporin for severe dry eye disease, highlighting quality of life benefits, improved eye care, and reduced eye pain in clinical practice.
The health professional described the symptoms related to severe dry eye disease and the quality of life benefits of treatment with ciclosporin for patients with severe disease. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe dry eye with keratitis (CFS grade 4, OSDI ≥23), whereas TGA label covers moderate to severe without specified severity thresholds.
Listed in law
PBS listings commencing 1 Oct 2021 were made by these 4 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 107 of 2021 | 28 Sep 2021 | Repealed | PDF ↗ |
| PB 97 of 2021 | 28 Sep 2021 | Repealed | PDF ↗ |
| PB 98 of 2021 | 28 Sep 2021 | Repealed | PDF ↗ |
| PB 99 of 2021 | 28 Sep 2021 | Repealed | PDF ↗ |