Xiidra, or Lifitegrast, is a new product aimed at treating Dry Eye Syndrome (DES). This eye drop is claimed to have beneficial properties in terms of reducing inflammation on the ocular surface, and those related to diseases affecting the eye. The only prescription drug that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of DES has been Restasis, which, although beneficial, has a number of significant negative side effects. The FDA has now approved Xiidra as well, although it is not yet available for prescription.
Xiidra, the ophthalmic solution containing Lifitegrast, has been FDA approved for the treatment of both symptoms of DES, and signs of DES. This approval was released on Monday, July 11, 2016. It is the first of its kind in the lymphocyte function-associated antigen (LFA-1) antagonist drugs, and the first that has received FDA approval.
The FDA’s Director of the Office of Antimicrobial Products, Edward Cox, M.D., has stated that normal tear production is required for people to experience optimum eye health and clear vision. Through the FDA Center for Drug Evaluation and Research, he stated that the approval of Xiidra is leading the way for new treatment options for those who suffer from DES.
What Is Dry Eye Syndrome?
DES is a term that encompasses a range of different conditions, including inadequate tear volume production, or insufficient quality of tears that are produced. Anyone can be susceptible to DES, although it most often affects the elderly. Around 5% of people between the ages of 30 and 40 experience DES, and between 10% and 15% of those over the age of 65. Women are also more commonly affected. If left untreated, it can lead to significant pain, as well as scars and ulcers on the cornea. People with DES also find it more difficult to perform regular daily activities, including using computers and reading. Furthermore, they often struggle to feel comfortable in dry environments, included in air conditioned rooms or on airplanes.
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Comparing Xiidra to Restasis
So how does Xiidra compare to Restasis? It can be difficult to draw a true comparison because Restasis has been available for over a decade, whereas Xiidra is not available on prescription yet. That said, there are a number of details that we do know, that enable at least a partial comparison. The table below highlights these facts.
The table below highlights these facts.
|Studies into safety and efficacy
|Large scale tests have taken place using more than a thousand patients. Four controlled, randomized, separate studies took place. Patients were aged between 19 and 97. 76% of participants were female and they were randomized between Xiidra eye drops and the placebo. All participants applied drops twice daily for 12 weeks. The study found that those who used Xiidra had significantly more improvement than those who did not. No studies have taken place in the effects of Xiidra on those below the age of 17, as it is rare for DES to occur in this population group.
|Various tests have demonstrated that Restasis has a positive effect on people who suffer from DES, helping to give them relief from an often painful condition. Thanks to the various studies, Restasis has long been the only FDA approved prescription drug for the treatment of DES.
|Discomfort, eye irritation, blurred vision, and dysgeusia (an unusual taste sensation).
|Burning, stinging, itching, redness, feeling a foreign body in the eye, blurry vision. Possible severe allergic reactions, characterized by eye swelling or severe eye pain or discomfort.
|Shire US Inc., Lexington, MA
|Allergan, Inc., Parsippany-Troy Hills, NJ
|Cyclosporine, which suppresses immune responses.
|Lifitegrast improves the signs and symptoms of DES.
|Cyclosporine increased production of tears and reduces eye inflammation.
|What is it for?
|Treatment of DES
|Treatment of DES caused by inflammation
It should be noted here that the goal of the FDA is to protect the health of the general public by making sure human and veterinary drugs are safe, effective, and secure. They also test medical devices, biological products used on humans, and vaccines. Furthermore, they hold responsibility for the security and safety of the food supply in this country, as well as dietary supplements, cosmetics, tobacco products, and any products that creates electronic radiation.
Comparing Restasis to Xiidra
Restasis has long been the only prescription drug available for people with Dry eye syndrome, leaving them with no other choice. However, there are some significant problems with the drug. First of all, it often takes months of use before any effect is noted. In the meantime, the painful effects of DES continue to exist, and people often do not have the patience or even ability to deal with those effects for prolonged periods of time. Additionally, Restasis commonly leads to side effects, which further stops people from sticking to the treatment. In fact, only around 15% of patients find that Restasis actually gives them significant relief, and this is often only after months of use.
In tests, Xiidra has been shown to have beneficial effects in just two weeks. This is a significant improvement, which is one of the reasons why ophthalmologists have been so excited about it, urging the FDA for approval. It also has an excellent safety profile, which means it is unlikely that people will suffer from any side effects more serious than the ones listed during the clinical trial (see table above). That said, Xiidra is a new drug and is not yet available for prescription, so the long-term efficacy must be proven first.