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
The PBAC recommended the listing of 0.09% OTX-101 (0.09% ciclosporin) for the treatment of chronic severe dry eye disease with keratitis. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost-effectiveness of 0.09% ciclosporin would be acceptable if it were cost- minimised against 0.1% ciclosporin.PSD · Mar 2022
The PBAC noted that the sponsor hearing indicated there was considerable variation between patients in terms of tolerability to treatment and treatment effectiveness 19PSD · Mar 2022
The submission presented a cost-minimisation analysis based on the claimed non- inferiority of 0.09% OTX-101 to 0.1% CsA CE. The key components and assumptions are shown below. 16PSD · Mar 2022
The equi-effective doses were estimated as 0.09% OTX-101 one drop twice daily and 0.1% CsA CE one drop daily, based on the dosing regimens used in the clinical trials and as recommended in the PIs.PSD · Mar 2022
The submission described 0.09% OTX-101 as non-inferior in effectiveness and safety compared with 0.1% CsA CE.PSD · Mar 2022
The therapeutic conclusion presented in the submission was not adequately supported by the evidence presented in the submission because the post hoc subgroups used in the indirect comparison were inappropriate as the basis for a statistical analysis. The PBAC considered that a naïve comparison without statistical analysis was more appropriate as the basis of assessment.PSD · Mar 2022
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
The submission assumed an RSA exists for 0.1% CsA CE with a % rebate for all use beyond the annual expenditure caps (based on the PBAC’s comments in the ciclosporin PSD March 2021 paragraph 7.15). The submission assumed 0.09% OTX-101 will join the RSA for 0.1% CsA CE. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Mar 2022
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 | — | 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.