A new treatment for moderate to severe keratoconjunctivitis sicca (dry eye disease), approved by the Therapeutics Goods Administration (TGA), has been welcomed by Sydney ophthalmologist Associate Professor Colin Chan.
A/Prof Chan, who operates a tertiary style dry eye practice, said although CEQUA won’t be the panacea for all dry eye patients, it will provide another option for patients who have been non-responsive to lubricants or other conventional therapies.
CEQUA is the first TGA approved calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with moderate to severe dry eye
“Many of the patients I see use eye drops every hour sometimes every ten minutes – these people are typically poor responders to medications, so the more options you have the better,” he said.
IMPACT CAN’T BE UNDERESTIMATED
Perhaps due to a lack of understanding, the general community tends to have little sympathy for people who live with dry eye disease, however A/Prof Chan says its impact cannot be underestimated.
“The consequences of dry eye disease have been well documented. It can impact on every aspect of a person’s day-to-day life; reading, looking at the computer, working, driving, watching TV and even sleeping.
“Once it gets to this level, the discomfort is so high that it’s hard to maintain anything visually attentive. Vision can begin to fluctuate, people lose work days and productivity… many of my patients have disturbed sleep because of pain at night,” he said.
POSITIVE STUDY RESULTS
CEQUA is the first TGA approved calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with moderate to severe dry eye, where prior use of artificial tears has not been sufficient.2,3 The solution inhibits T-cell activation and inflammatory cytokine production,2,3 thereby reducing the underlying inflammation associated with dry eye disease.4,5 One drop is administered to the affected eye(s) twicedaily (approximately 12 hours apart).3
The most common adverse event reported was instillation site pain, which was mostly mild, transient, and resolved within five minutes following instillation.1,6
MORE SOLUTIONS IN PIPELINE
Dry eye affects 7.4% of the Australian population,7 with 50% of people over 50. A/Prof Chan said younger patients are increasingly affected due to constant use of digital screens as well as air conditioned environments. In response to this he said there is a “wave of new products being researched and coming through”.
These include Xiidra, which was recently acquired by Novartis. Additionally, treatment with serum autologous tears has been made more accessible with packaging changes and expanded blood withdrawal options.
This is exciting news when you take into consideration that one in five dry eye patients are dissatisfied with their overall treatment due to lack of symptom relief, the time taken to relieve symptoms, and treatment side-effects.8
“Whereas many ophthalmic conditions can be quickly fixed, dry eye disease is for life – these patients are living with a chronic condition and some get to a point where they come in and say they can’t continue to live in such pain,” A/Prof Chan said.
“It is difficult to tell them that we don’t fully understand the disease and that while we can make it better, there is no cure. So we give them hope by promising that although they may not respond to one treatment, we will try every treatment available. This is why it’s great when I can offer them something else to try.”
A/Prof Colin Chan is the Chairman for the Advisory Board on CEQUA for Sun Pharmaceuticals but has declined to receive any honoraria or payment from Sun Pharmaceuticals. Instead a donation on his behalf has been made to Red Cross Australia.
- 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, 2019. 126(9): p. 1230-1237. Therapeutic Goods Administration (TGA). [insert when available on TGA website]. [cited 2019; Available from: www.tga.gov.au/.
- Cequa Product Information. 2020 Feb, 2020]; Available from: Sun Pharma by calling 1800 726 229.
- Hessen, M., S. Karakus, and E.K. Akpek, Management of Dry Eye in Sjögren’s Syndrome. Current Treatment Options in Rheumatology, 2015. 1(3): p. 292-304.
- Rhee, M.K. and F.S. Mah, Clinical utility of cyclosporine (CsA) ophthalmic emulsion 0.05% for symptomatic relief in people with chronic dry eye: a review of the literature. Clinical ophthalmology (Auckland, N.Z.), 2017. 11: p. 1157-1166.
- Mandal, A., et al., Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa) for Dry Eye Disease. Pharmaceutical Research, 2019. 36(2): p. 36.
- Gayton, J.L., Etiology, prevalence, and treatment of dry eye disease. Clinical ophthalmology (Auckland, N.Z.), 2009. 3: p. 405-412.
- 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, 2019. 38(10): p. 1259-1265.