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Tuesday / May 21.
HomeminewsCequa Now Reimbursed for Chronic Severe DED

Cequa Now Reimbursed for Chronic Severe DED

Cequa (ciclosporin 900 microgram/mL) has been listed on the Pharmaceutical Benefits Scheme (PBS) for a subsection of patients living with chronic, severe dry eye disease (DED) with keratitis.1

The aqueous, nanomicellar ophthalmic ciclosporin solution is indicated for increasing tear production in moderate to severe DED, where prior use of artificial tears has not been sufficient.2

Cequa… has been listed on the Pharmaceutical Benefits Scheme (PBS) for a subsection of patients living with chronic, severe dry eye disease (DED) with keratitis

Cequa’s delivery system improves the ciclosporin’s bioavailability, and enables a more than 10-fold increase in aqueous solubility, compared with a 0.05% ciclosporin ophthalmic emulsion.3,4

Cequa inhibits T-cell activation and reduces inflammation associated with dry eye disease.5,6

Two clinical studies, OTX-101-2014-0017 and OTX-101-2016-0018, demonstrated significantly reduced signs of dry eye disease rapidly, with noticeably reduced corneal staining at 28 days, and reduced conjunctival staining at 56 days.7,8 Cequa’s long-term safety is supported.9 The most common, adverse event is mildly transient instillation site pain.10

To learn more about Cequa, contact Sun Pharma Medical Information Line on (AUS)1800 726 229.

References
1. Therapeutic Goods Administration (TGA). CEQUA. (Sun Pharma ANZ Pty Ltd).
2. Pharmaceutical Benefits Scheme. Ciclosporin: Eye drops 900 micrograms per mL, single dose units, 0.25 mL, 60; Cequa 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).
3. CEQUA. Unique NCELL Technology and formulation provide superior delivery over cyclosporine emulsion 0.05%, www.cequapro.com/ncell-technology. (2023).
4. Malhotra, R. et al. Effect of OTX-101, a novel nanomicellar formulation of cyclosporine a, on corneal staining in patients with keratoconjunctivitis sicca: a pooled analysis of Phase 2b/3 and Phase 3 studies. Cornea 38, 1259-1265, doi:10.1097/ico.0000000000001989. (2019).
5. Rhee, M. K. and Mah, F. S. 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, 1157-1166, doi:10.2147/OPTH.S113437 (2017).
6. Hessen, M. and Akpek, E. K. Dry eye: an inflammatory ocular disease. J Ophthalmic Vis Res, 9, 240-250 (2014)
7. 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. Clin Ophthalmol, 12, 1921-1929, doi:10.2147/OPTH.S175065. (2018).
8. Goldberg, D. F. 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, 1230-1237, doi:10.1016/j.ophtha.2019.03.050. (2019).
9, Sheppard, J. et al. Phase 3 efficacy (worse-eye analysis) and long-term safety evaluation of otx-101 in patients with keratoconjunctivitis sicca. Clin Ophthalmol, 15, 129-140, doi:10.2147/opth.S279364. (2021).
10. Mandal, A., Gote, V., Pal, D., Ogundele, A. & Mitra, A. K. Ocular pharmacokinetics of a topical ophthalmic nanomicellar solution of cyclosporine (cequa) for dry eye disease. Pharmaceutical Research, 36, 36, doi:10.1007/s11095-018-2556-5. (2019).