ARTG Entry
CEQUA
ARTG entry for CEQUA (ciclosporin), ARTG 313780 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Sun Pharma
- Active ingredient: ciclosporin
- Therapeutic area: Ophthalmology
What it is
CEQUA is ciclosporin 900 microgram/mL eye drops supplied in single dose units of 0.25 mL.
Approved indications
— To increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye) where prior use of artificial tears has not been sufficient.
Key safety warnings
Nonclinical studies have supported the local ocular tolerability of CEQUA eye drops and an absence of systemic toxicity. Clinical evaluation based on two pivotal efficacy and safety studies demonstrated the drug's effectiveness in increasing tear production.
PBS listing
CEQUA eye drops 900 micrograms per mL in single dose units of 0.25 mL, pack of 60, is listed on the PBS with authority required restriction at an ex-manufacturer price of A$65.00.
Regulatory history
The TGA approved CEQUA (ciclosporin) 900 µg/mL eye drops on 28 January 2020. This decision was based on positive quality, nonclinical, and clinical evaluations, with specific conditions imposed for marketing related to product labelling. In March 2022, the PBAC recommended CEQUA for chronic severe dry eye disease with keratitis.