Lifitegrast data support dry eye efficacy over placebo drops
Twice-daily drops showed improvement in eye dryness scores after two weeks
Newly approved lifitegrast (Xiidra, Shire) has provided a useful alternative to cyclosporine (Restasis, Allergan) for some patients, said Cynthia Matossian, MD.
“We had a subset of patients with ocular surface disease who tried the existing medication, but for a variety of reasons, they were unable to tolerate it,” said Dr. Matossian, Matossian Eye Associates, Doylestown, PA. “Lifitegrast has helped that subset tremendously.”
Dr. Matossian highlighted the results of the OPUS-2 and OPUS-3 phase III trials. Along with two other studies (OPUS-1 and SONATA), these trials provided the data which led the FDA to approve lifitegrast for treatment of dry eye.
Patients taking lifitegrast for 84 days reported a 10-point greater improvement in symptoms on a 100-point scale compared with those taking a placebo. About half of those taking lifitegrast experienced a treatment emergent adverse event, compared with a quarter of those taking the placebo, but most of these were mild.
In addition to topical cyclosporine, the only other FDA-approved medication for dry eye, options have included artificial tear substitutes, lubricant gels and ointments, nutritional supplements, corticosteroids, intense pulsed light, thermal pulsation therapy, and punctal plugs. Still, satisfaction remains elusive for some patients.
The difficulty in treating these symptoms may stem from the multiple factors. These can include age, hormonal status, genetics, gender, immune status, innervations status, nutrition, pathogens, and environmental stress.
Researchers believe these factors can create an imbalance between secretion and degradation of the tear film decreasing tear secretion, increasing tear evaporation, or altering tear film stability. This may result in desiccation and epithelial damage, triggering inflammation.
Both cyclosporine and lifitegrast are applied topically as eye drops and appear to work by modulating T-cells involved in the inflammatory cycle, Dr. Matossian said.
Cyclosporine has been used to treat a variety of inflammatory diseases, including psoriasis, rheumatoid arthritis, ulcerative colitis, and ocular inflammation.
According to Clyde Shultz (Ophthalmol Eye Dis. 2014; 6: 37-42), it binds to cyclophilin in lympohcytes, inhibiting calcineurin, and ultimately preventing it from activating the transcription product of interleukin-2 which T-cells need to replicate.