Cequa now listed on the PBS

In an exciting announcement, starting from 1 June 2023, the highly anticipated Cequa (ciclosporin 900 microgram/mL) has been listed on the PBS for adults living with chronic, severe dry eye disease with keratitis.

Cequa is an aqueous, nanomicellar ophthalmic ciclosporin solution that helps to increase tear production in individuals with moderate to severe dry eye disease (keratoconjunctivitis sicca) where prior use of artificial tears has been insufficient.

In the form of an eye drop, Cequa is a clear and preservative-free solution that penetrates the aqueous layer of the tear film in the eye to deliver more ciclosporin to the ocular surface. It is administered topically, with one drop twice a day (12 hours apart) into the affected eye(s). The treatment can also be used alongside artificial tears, with a 15-minute interval between products.

Cequa was first approved by the Therapeutic Goods Administration (TGA) in February 2020 in Australia, however, it did not receive PBS approval at the time.

Optometry Australia’s Chief Clinical Officer Luke Arundel said the availability of another ciclosporin treatment on the PBS, which targets the underlying conditions of dry eye disease, is welcome news for both optometrists and patients.

‘Severe instances of dry eye disease can compromise vision, quality of life and everyday productivity. It can be painful and uncomfortable, especially when typical over-the-counter treatment options have failed to provide relief.

‘Having Cequa available on the PBS is welcome news for optometrists and for patients suffering from this chronic disease.

‘All therapeutically qualified optometrists in Australia can prescribe Cequa for appropriate patients as a private prescription. If prescribing under the PBS scheme, authority is required. The patient will need to meet a list of criteria as listed on the PBS website under ‘authority required’.’

Supporting data that led to PBS listing

The inclusion of Cequa on the PBS is supported by two randomised, vehicle-controlled clinical studies: OTX-101-2014-001 and OTX-101-2016-00. These studies revealed significant and rapid reduced signs of dry eye disease, such as reduced corneal staining at 28 days and reduced conjunctival staining at 56 days.

About Cequa

Cequa’s delivery system improves the way ciclosporin is absorbed by the body, leading to more effective treatment. The treatment is delivered using nanomicellar technology, and allows for a more than 10-fold increase in aqueous solubility, compared with a 0.05% ciclosporin ophthalmic emulsion.

Cequa has been found safe for long-term use; the most common, adverse side-effects were mild instillation site pain, conjunctival hyperaemia and punctate keratitis.

For more information on prescribing medicines in optometry, visit the Prescribing Medicines & PBS section of our website.

References

1. Pharmaceutical Benefits Scheme. Ciclosporin: Eye drops 900 micrograms per mL, single dose units, 0.25 mL, 60; Cequa®, https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2022-03/ciclosporin- eye-drops-900-micrograms-per-ml-single-dose-units-0-25-ml-60-cequa. (2022).
2. Therapeutic Goods Administration (TGA). CEQUA (Sun Pharma ANZ Pty Ltd).
3. CEQUA® Approved Product Information. (2020).
4. Rhee MK & Mah FS. Clinical utility of cyclosporine (CsA) ophthalmic emulsion 0.05% for symptomatic relief in people with chronic dry eye: a review of the literature. Clin Ophthalmol 11. (2017).
5. Goldberg DF & et al. A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease. Ophthalmology 126(9), 1230-1237. (2019).
6. Tauber J & et al. A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clinical ophthalmology (Auckland, N.Z.) 12, 1921-1929. (2018).
7. How to use Cequa, https://www.cequa.com/how-to-use. (2023).