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 inhibits T-cell activation and inflammatory cytokine production,2,3 thereby reducing underlying inflammation associated with DED, and stimulating natural tear production.4-6

The PBS listing of Cequa is based on two randomised, vehicle-controlled clinical studies, OTX-101-2014-0017 and OTX-101-2016-00.6 Both studies demonstrated clinically and statistically significant improvements with Cequa in tear production and ocular surface integrity in patients living with dry eye disease over 84 days (12 weeks).6,7 Cequa significantly reduced the signs of DED rapidly, with noticeably reduced corneal staining at 28 days, and reduced conjunctival staining at 56 days.6 To achieve the best results, Cequa is recommended to be administered consistently for at least three months. 5,8

According to ophthalmic surgeon, Dr Alison Chiu from Envision Eye Centre in Sydney, DED is a widespread and complex disease with a significant unmet clinical need.

“Dry eye disease is highly prevalent, affecting nearly 10% of the Australian population.9 As a leading cause of patient visits to both optometrists and ophthalmologists, the disease also places a substantial burden on the healthcare system.

“The management of dry eye disease is highly complicated because of its multifactorial aetiology.10 Ocular lubricants, such as artificial tears, are a mainstay of disease management, however only provide palliative relief and do not target the underlying pathophysiology of dry eye disease,”10,11 said Dr Chiu.

“Subsequently, one in five patients living with dry eye disease are dissatisfied with their overall treatment due to lack of symptom relief, the time taken to relieve symptoms, and treatment side-effects.12

“Ciclosporin was the first agent used in the treatment of dry eye to address the pathogenesis of the disease,13 and is recommended as one component of the Step 2 treatment regime for dry eye disease. 14 However, the delivery method has been historically challenging,”15 Dr Chiu said.

“This PBS listing is particularly timely and will help Australia match the treatment options available overseas. As clinicians, we welcome the availability of another treatment on the PBS, to help address the current unmet need for this patient population living with chronic severe dry eye disease.”

Cequa’s nanomicelles are formed using polymers that self-assemble into a hydrophobic core and a hydrophilic outer shell, enabling the ciclosporin molecules to overcome solubility challenges.16 This nanomicellar technology allows for a more than 10-fold increase in the aqueous concentrations of ciclosporin compared with ciclosporin 0.05% ophthalmic emulsion.6,12,17 Furthermore, the smaller particle size of Cequa improves the bioavailability and physiochemical stability of the formulation, thereby enhancing delivery of ciclosporin to relevant ocular tissue.6,18

References available at mivision.com.au