When counseling and OTC methods don’t offer relief, it’s time to write a prescription.
If I were to open a new practice today, I would specialize in the diagnosis and management of dry eye disease (DED). The need is there, and several factors would allow the development of a successful practice. Consider: More than 30 million Americans suffer from the disease, many of whom are untreated. Some of the treatment and services are covered by third-party payers. Initial diagnosis requires little or no increased investment in equipment. And, it is a chronic and progressive disease process for which more treatment options continue to become available.
In May, the Tear Film & Ocular Surface Society (TFOS) presented the conclusions and recommendations of the TFOS Dry Eye Workshop II (DEWS II), creating new discussion and adding a global standardization and definition to the disease process. The TFOS DEWS II is the sequel to the original TFOS DEWS of 10 years ago.
The report, available for free atTearFilm.org, updated the definition of dry eye as “a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.”
MAKING THE DIAGNOSIS
For treating patients with dry eye, I use as my guide the local coverage determination (LCD) from First Coast Service Options, Inc., the Medicare Administrative Contractor in Florida, which offers a clear and simple path for determining medical necessity and implementing step therapy.
To make the diagnosis, you’ll need a history of the disease signs and symptoms along with any environmental conditions or medications that may be contributing factors. To classify the severity of DED, use one of these questionnaires: the Ocular Surface Disease Index, the Standard Patient Evaluation of Eye Dryness Questionnaire, and the 5-Item Dry Eye Questionnaire. Other available questionnaires include the McMonnies Questionnaire and Subjective Evaluation of Symptoms of Dryness.
The LCD doesn’t require testing for mild DED, but if the patient has moderate to severe DED, as indicated from the questionnaire, then additional testing is necessary. This includes the Schirmer test, vital dye staining (fluorescein, rose bengal, lissamine green), tear film break-up time (TFBUT), and slit lamp evaluation with particular attention to conjunctiva and cornea, tear meniscus height, and eyelid and meibomian glands.
Additionally, testing of tear osmolarity and inflammatory markers is indicated for making the initial diagnosis and possibly at one follow-up visit. For testing inflammatory markers, the LCD specifies using InflammaDry, which Quidel Corp. acquired from Rapid Pathogen Screening. This test identifies elevated levels of matrix metallopeptidase 9 (MMP-9) protein in tear fluid samples taken from the palpebral conjunctiva.
Once you diagnose the patient, the LCD offers a definitive regimen of step therapy. This starts with eliminating any environmental factors and medications, when feasible, that may be contributing to the patient’s DED. This is followed by artificial tears, treatment of blepharitis or meibomianitis, treatment of lid abnormalities, medications, and punctal occlusion
THE Rx ROUTE
I follow the step therapy outlined in the Florida LCD. However, when a patient has moderate-to-severe dry eye that has not been alleviated with environmental modification and counseling along with artificial tears and concurrent management of lid disease, it’s time to add a topical Rx.
We now have several medications available, all of which are considered conservative interventions for DED. These include corticosteroids, systemic omega-3 fatty acids (docosahexaenoic acid, eicosapentaenoic acid, and alpha-linolenic acid), RESTASIS (cyclosporine ophthalmic emulsion) 0.05% from Allergan, and Xiidra (lifitegrast ophthalmic solution) 5% from Shire Pharmaceuticals.
RESTASIS is an immunomodulator that limits T lymphocyte activity and prevents the release of cytokines, thus reducing inflammation. RESTASIS is indicated to help increase the eye’s ability to produce tears—an ability likely suppressed by ocular inflammation.
Advantages of RESTASIS: It has a long track record—the FDA approved RESTASIS in 2002—and is covered by numerous third-party payers. RESTASIS has been available in preservative-free single-use vials, and last year, the FDA approved RESTASIS MultiDose, a 5.5ml bottle with a 30-day supply.
Dosage is twice daily. Because patients may not notice immediate improvement, I consider it critical to schedule the patient for a follow-up visit about four to six weeks later. That way, I can reassure them and prevent them from stopping the medication before it has had time to start providing noticeable symptomatic relief.
Burning is the most common complaint I hear about Restasis. Other side effects include eye redness, discharge, watery eyes, eye pain, foreign-body sensation, itching, stinging and blurred vision.
In July 2016, the FDA approved Xiidra, the first prescription eye drop approved for treating both signs and symptoms of DED in adults.
Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist. Xiidra’s active ingredient, lifitegrast, is designed to specifically block the interaction of intercellular adhesion molecule-1 (ICAM-1) and LFA-1, which plays important roles in the inflammation behind DED.
In clinical trials, Xiidra demonstrated significant reduction in both signs and symptoms of DED by week 12 compared with the vehicle, with symptom improvement observed at Day 14.
Xiidra comes in single-dose containers. Dosage is twice daily. Xiidra is generally well tolerated. The most common adverse reactions reported include instillation site irritation, an unusual taste (dysgeusia) and reduced visual acuity.
Clinically, the decision to use Xiidra or Restasis is driven by the severity of the patient’s DED. Personal experience has shown that each one may work better in certain patients than in others.
It’s important to educate your patients that either treatment will be long-term when dealing with the chronic and progressive nature of DED. Follow patients regularly and reassure them when initiating therapy so that they continue the use of the medication to allow for the therapeutic benefit.
Coverage of these medications by patients’ insurance will also be a determining factor in their continuing use to treat this chronic disease. I have been successful with both Rx medications. Be aware of each patient’s insurance, and be diligent at getting approvals or writing the Rx in the specific manner required for coverage by the insurer. OO
Carl Spear, OD, MBA, FAAO, practices in the Panhandle of Florida. Dr Spear is a lecturer, writer and consultant specializing in practice management and strategic eyecare industry analysis.