Compounded cyclosporine may be option for dry eye treatment
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Klarity-C was a suitable alternative treatment for patients with dry eye disease, according to a study published in Clinical Ophthalmology.
OSN Cataract Surgery Board Member Cynthia A. Matossian, MD, FACS, told Ocular Surgery News that while therapies such as Restasis (cyclosporine 0.05%, Allergan), Xiidra (lifitegrast 5%, Novartis) and Cequa (cyclosporine 0.09%, Sun Ophthalmics) have been available for many years, some patients do not have access to them.
“We’re fortunate that not only do we have more diagnostic tools to help eye care providers diagnose dry eye, but there’s an emphasis to look for it early and actively treat it because we know that dry eye disease is chronic and progressive,” Matossian said. However, “patients are having trouble accessing these branded immunomodulators. Many insurances don’t cover them, the cost of the co-pay is extremely high, or they have a big deductible to meet.”
In these situations, Matossian said her go-to drug is compounded Klarity-C (topical cyclosporine 0.1% in chondroitin sulfate emulsion, ImprimisRx). She said patients can pay cash and have it mailed directly to their homes.
“It eliminates going to the pharmacy for patients, and it obviates completing prior authorization paperwork by senior technicians,” she said.
Matossian and colleagues evaluated the drug in a retrospective study comprising 100 eyes of 50 patients with dry eye. All patients had a pretreatment Ocular Surface Disease Index (OSDI) of more than 12 or corneal staining grade greater than 1. Patients underwent treatment with Klarity-C twice daily for 3 months between April 2019 and July 2019.
The main outcomes of the study were changes in OSDI score and corneal staining grade after 3 months of therapy from baseline. Patients were grouped based on disease severity, with OSDI score of 0 to 12 considered as normal, 13 to 22 as mild, 23 to 32 as moderate and 33 to 100 as severe.
After 3 months, patients experienced a significant improvement in mean OSDI score (38.19 vs. 24.18, P < .001) and corneal staining grade (3.62 vs. 2.2, P < .001). There was also a reduction in the proportion of patients with severe dry eye (62% to 20%), while 34% of patients fell within the normal range of OSDI.
The percentage of eyes with a corneal staining grade of 2 or 3 decreased. At baseline, 21% of eyes were graded at 2 or 3, which decreased to 8% at 3 months. Additionally, 50% of eyes had a corneal staining grade of 0.
Klarity-C was safe with no adverse events occurring in the study. The authors hypothesized that the additional lubrication and mild anti-inflammatory effect provided by chondroitin sulfate in addition to cyclosporine might contribute to better comfort for patients and improve compliance. However, they did not specifically evaluate the drug’s tolerability.
Matossian said the study showed that patients who have difficulty obtaining immunomodulators due to insurance issues have a good alternative with cyclosporine 0.1% in chondroitin sulfate emulsion.
“It’s a workaround if the patient’s insurance doesn’t cover other immunomodulators or if the cost is prohibitive. It’s my last resort if I cannot get the branded products,” she said.
“There haven’t been any head-to-head trials, but as our study results show, it definitely demonstrated statistically significant improvement in the various parameters that we outlined in the study,” Matossian said.
- For more information:
- Cynthia A. Matossian, MD, FACS, can be reached at Matossian Eye Associates; email: cmatossian@cmassociatesllc.net.
Perspective
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Dry eye is incredibly prevalent, and as a chronic, progressive condition, it needs to be treated. However, there are several challenges in the clinical management of dry eye, including medication coverage, high pharmaceutical deductibles, tolerability, speed of onset of relief, adherence to therapy and patient confidence in the therapy. It is refreshing to see some clinical data around a prescription approach that could address some of the cost, accessibility and tolerability issues that are associated with topical immunomodulators.
Matossian and colleagues published a well-done retrospective chart review of patients with a range of dry eye disease severity treated with a chondroitin sulfate formulation of 1% cyclosporine. The reported highly statistically significant improvements in fluorescein staining and OSDI scores provide some clinical evidence around the benefits of a chondroitin sulfate-formulated immunomodulator. While this is encouraging data, larger-scale prospective studies with expanded dry eye metrics such as Schirmers scores, tear breakup time, osmolarity and MMP-9 as well as safety metrics around adverse events and blood levels with long-term therapy are the next steps. Additional data would contribute to the acceptance of this formulation when patients and doctors are squeezed by access, tolerability and cost.
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