Indications from a Medscape survey are that clinicians will investigate lifitegrast ophthalmic solution (Xiidra, Shire) for treatment of dry eye disease (DED) now that it has been approved, but most will need to be convinced of its merits.
Some may already be convinced, though. One expert told Medscape that the drug will be a "game changer."
The US Food and Drug Administration (FDA) approved lifitegrast, a lymphocyte function–associated antigen 1 agonist, in July for the treatment of both signs and symptoms of DED, the first solution to treat both. The twice-daily drops are the first treatment approved for DED in more than a decade.
The previously approved cyclosporine ophthalmic emulsion (Restasis, Allergan) stimulates tear production. It is approved for the signs, but not the symptoms, of dry eye.
How It Might Change Practice
Medscape asked 51 primary care physicians (PCPs), 48 ophthalmologists, and 53 optometrists from 10/14/15 – 10/19/15, before the drug's approval, about whether or how lifitegrast's approval might change their practice. The survey's margin of error is ±7.9% at a 95% confidence level, using a point estimate of 50%.
The option will no doubt be an important consideration, as DED patients make up a significant number of the patients the groups see. PCPs estimated the percentage of their patients who are diagnosed with DED to be 15.75%. For ophthalmologists, the number was 38.44%; it was 35.11% for optometrists.
On average, clinicians in all three groups estimated the prevalence of levels of severity of the disease in their patients as follows: mild (56.03%), moderate (30.63%), and severe (13.34%).
The three clinician groups indicated that they see the new treatment as something they would prescribe more for patients with moderate to severe DED than for patients with mild DED.
Among the three groups of clinicians who were aware of lifitegrast, on average, physicians answered that if lifitegrast were approved, they would likely prescribe it within the first year for 41.43% of their patients with moderate to severe DED. PCPs answered 43.61%, ophthalmologists answered 40.71%, and optometrists answered 40%.
The numbers were lower for patients with mild DED (22.86%). PCPs answered they would likely prescribe it within the first year for 29.17% of these patients. Ophthalmologists answered 14.52%, and optometrists answered 26.47%.
As to which treatments they had recommended in the past 6 months for what percentage of patients and the average estimated efficacy, the results were as follows on average for all three groups combined.
|Treatment Recommended||Percentage of Patients||Efficacy Estimate (1-7 Scale*)|
|OTC artificial tear substitutes, gels or ointments||49.24||4.78|
|Restasis (cyclosporine ophthalmic)||17.58||5.1|
|Steroid eyedrops †||11.96||5.43|
|Flax seed oil, fish oil, or omega 3 supplements||8.55||3.99|
|Temporary punctal occlusion||5.65||4.55|
|Nondissolving punctal plugs and punctal occlusion by cautery||2.32||4.66|
|Eye protection (eg, moisture chamber spectacles)||1.86||4.41|
|Lipiflow (an FDA-cleared device for removing gland blockages and restoring gland function)||0.46||n/a|
*1 is not at all effective, and 7 is extremely effective.
†For example, loteprednol etabonate (multiple brands) or fluorometholone (multiple brands).
Knowledge of Lifitegrast Low
Clinicians were asked about their knowledge of lifitegrast, and 65% of PCPs, 56% of ophthalmologists, and 68% of optometrists said they had never heard of the treatment.
When given choices about the statement that best described their feeling toward it, the largest response among those aware of lifitegrast, given by an average 41% across all three groups of clinicians, was, "I will investigate the potential for lifitegrast with some of my own patients in comparison to other products, then wait to see their response before accepting it fully."
In a Medscape perspective piece published July 26, Christopher J. Rapuano, MD, and his practice partner, Parveen Nagra, MD, with the Cornea Service at Wills Eye Hospital in Philadelphia, Pennsylvania, talked about the possibilities for lifitegrast.
"We have artificial tears, and we have an anti-inflammatory medicine, Restasis (cyclosporine ophthalmic emulsion)," Dr Nagra said. "We can occasionally try different antibiotics or thicker lubricants and oral medications, but there are patients for whom we are not adequately treating dry eyes who remain symptomatic. So, this is very promising for those patients."
Dr Rapuano went a step further, telling Medscape that "this will be a big game changer in the treatment of dry eye."
Costs are reported to be similar for the two drugs. A recent article from FiercePharma quotes Evercore ISI investment banking analyst Umer Raffat as saying lifitegrast will cost $5000 per year. "A 30-day supply will cost $426.73, which just so happens to be the exact same price of a 30-day supply of rival Allergan product," he told the publication.
According to the manufacturer of lifitegrast, the most common adverse effects of the medication are eye irritation, discomfort or blurred vision when the drops are applied, and an unusual taste sensation (dysgeusia).
About 5% of adults aged 30 to 40 years and 10% to 15% of those older than 65 have dry eye disease; it is more common among women. Untreated, severe dry eye can lead to pain, ulcers, or corneal scarring.
Medscape Medical News © 2016 WebMD, LLC
Send comments and news tips to firstname.lastname@example.org.
Cite this: Many Clinicians Take Wait-and-See Attitude to New Dry Eye Drug - Medscape - Aug 05, 2016.