The last time a medication was approved for the treatment of dry eye syndrome? October 2003. That medication was the blockbuster Restasis, still commanding the dry eye marketplace 13 years later. Over those 13 years, we've learned a lot more about dry eye and the 16 million Americans that are diagnosed and treated for it every year. They suffer from symptoms like burning, watering, redness, blurry vision, and tired eyes. For many, even the best medical care available on the market is not enough to overcome their discomfort. That's why the world is so excited for a new medication on the market. Shire's Xiidra was FDA approved on July 12th for the treatment of the signs and symptoms of dry eye disease (Restasis is FDA approved to treat the signs of dry eye disease only). Slated to become commercially available this fall, there's still a lot about Xiidra that patients and eyecare providers don't know. We don't know the cost, we don't know exactly how patients will respond in our offices, we don't know how Xiidra will compete with Restasis, and we don't know how insurance coverage will look. Here's what we do know so far:
What It Is:
Xiidra (lifitegrast 5%) is a non-steroidal anti-inflammatory eye drop, treating dry eye by disrupting the inflammatory cascade responsible for much of the discomfort and ocular surface changes associated with dry eye disease. It specifically targets intracellular adhesion molecule 1 (ICAM-1); Xiidra binds to proteins on the surface of white blood cells (leukocytes) where ICAM-1 would typically bind, thus blocking ICAM-1 from being able to attach and signal the inflammatory cascade. When ICAM-1 molecules bind to leukocytes, they signal T-cells (the body's main inflammatory cell unit) to the area. Xiidra prevents this binding, and thus T-cells aren't signaled to migrat to the ocular tissue. What does blocking the inflammatory cascade mean to you? Inflammation is what makes dry eye so miserable - redness, burning, and surface cell damage (called superficial punctate keratitis -- basically dried out corneal cells sloughing off the cornea creating symptoms like sharp pain and blurry vision).
What It Does:
In the clinical trials that earned Xiidra FDA approval, over 1000 people with dry eye disease were treated with Xiidra over the course of 12 weeks and the results were compared to placebo treatment. Patients being treated with Xiidra showed statistically significant improvement at Week 6 and Week 12 as compared to those on placebo eye drops in both the signs and symptoms of dry eye, as measured by a subjective symptom scoring questionnaire called the Eye Dryness Score (EDS) and inferior corneal staining (see superficial punctate keratitis above).
How It's Used:
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What It Is:
Xiidra (lifitegrast 5%) is a non-steroidal anti-inflammatory eye drop, treating dry eye by disrupting the inflammatory cascade responsible for much of the discomfort and ocular surface changes associated with dry eye disease. It specifically targets intracellular adhesion molecule 1 (ICAM-1); Xiidra binds to proteins on the surface of white blood cells (leukocytes) where ICAM-1 would typically bind, thus blocking ICAM-1 from being able to attach and signal the inflammatory cascade. When ICAM-1 molecules bind to leukocytes, they signal T-cells (the body's main inflammatory cell unit) to the area. Xiidra prevents this binding, and thus T-cells aren't signaled to migrat to the ocular tissue. What does blocking the inflammatory cascade mean to you? Inflammation is what makes dry eye so miserable - redness, burning, and surface cell damage (called superficial punctate keratitis -- basically dried out corneal cells sloughing off the cornea creating symptoms like sharp pain and blurry vision).
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| Superficial punctate keratisis: when corneal surface epithelial cells dry out, the cell wall break and they begin to slough off. The process can cause you to feel sharp, shooting pain and chronic discomfort and visual fluctuations. via |
What It Does:
In the clinical trials that earned Xiidra FDA approval, over 1000 people with dry eye disease were treated with Xiidra over the course of 12 weeks and the results were compared to placebo treatment. Patients being treated with Xiidra showed statistically significant improvement at Week 6 and Week 12 as compared to those on placebo eye drops in both the signs and symptoms of dry eye, as measured by a subjective symptom scoring questionnaire called the Eye Dryness Score (EDS) and inferior corneal staining (see superficial punctate keratitis above).
How It's Used:
- Like Restasis, Xiidra is dosed 1 drop in both eyes 2 times a day.
- Clinical trials suggest that Xiidra will begin improving both the signs and symptoms of dry eye as early as 6 weeks into treatment, much faster than Restasis whose clinical trials showed improvement in signs of dry eye (judged by Shirmer score) at 6 months versus placebo.
- Xiidra and Restasis both target the inflammatory cascade, but they do not target the same molecules so there is no scientific data that suggests they could not be used in combination.
- Xiidra is pregnancy category C (meaning it was not tested for safety)
- Xiidra is approved for ages 17 and up
- Xiidra is not approved for use with contact lenses; you must remove contact lenses before insertion and wait 15 minutes before reinserting them.
- Side effects of Xiidra:
- 5-25% of users experienced burning with drop insertion, altered or bad taste (called dysguesia), and blurry vision after insertion
- 1-5% of users reported adverse reactions of ocular redness, headache, watering eyes, runny nose, and ocular discharge
What We Don't Know:
Now that Xiidra is FDA approved, Shire has the task of setting the price for the medication and working with government and insurance coverage. Cash price for competitor Restasis is currently over $400 for a 30 day supply when using 2 vials a day. Analysts expect Xiidra will be priced similarly. There is debate that Xiidra may try to come in slightly lower to directly compete with Restasis, but there are also analysts predicting Xiidra will come in slightly above Restasis in cost since they have a significantly faster method of action and Xiidra is also approved to treat the symptoms of dry eye while Restasis is not.
Stay tuned as more information become available we will continue to report on this exciting new treatment option!
