When FDA-approved treatments for dry eye disease don’t work, it can be frustrating for both doctors and patients. To alleviate this frustration, doctors often turn to nontraditional treatment alternatives.
Here, corneal specialists discuss these solutions.
Ocular Nutritional Supplements
John D. Sheppard, MD, MMSc, president of Virginia Eye Consultants, professor of ophthalmology, and clinical director of the Lee Laboratory for Ocular Pharmacology at Eastern Virginia Medical School, in Norfolk, Va., says he’s a big fan of natural solutions that are evidence-based:
Why: Although FDA-approved products have strong efficacy and safety records, they don’t work for all patients, and there is always going to be a population of patients who get discouraged by these products’ side effects, he notes.
“High dose nutritionals combined with an environmental control, such as the use of a humidifier, has next-to-no side effect profile, meaning that there is ‘no harm done,” he offers.
He adds that he has prescribed ocular nutritional supplements as a first-line treatment for this reason.
Dr. Sheppard was involved in a study that demonstrated daily dietary supplementation with a unique combination of fatty acids (GLA, EPA and DHA) was effective in improving ocular irritation and in halting the progression of moderate to severe dry eye disease.
Barrier: Just as patients can have a negative reaction to FDA-approved products, they can have a negative reaction to the ingredients in ocular nutritional supplements. As a result, it makes sense to inquire about possible allergies and sensitivities. In addition, a history of anticoagulation therapy is important to assess, as these nutraceuticals may further augment an anticoagulated state, potentially resulting in bleeding, notes Kendall E. Donaldson, MD, MS, professor of clinical ophthalmology at the Bascom Palmer Eye Institute, University of Miami School of Medicine.
There have been several peer-reviewed studies over the last decade to support the potential ocular surface benefits of omega supplementation in various forms, she adds.
Ocular nutritional supplement companies include Biosyntrx, Covalent Medical, Focus Laboratories, EyePromise, Guardion Health Sciences, Nordic Naturals, Physician Recommended Nutraceuticals and ScienceBased Health.
Stephen Pflugfelder, MD, professor and James and Margaret Elkins Chair in Ophthalmology at the Baylor College of Medicine in Houston, suggests considering this approach when FDA-approved medications and natural solutions aren’t effective.
Compounding might include producing a prescribed medication in a preservative-free formulation or with a different vehicle or strength, he explains.
Why: “There are compounded products available in different concentrations and in different vehicles, which sometimes patients end up liking more,” he says.
Most often, if a patient is going to be on a medication chronically, Dr. Pflugfelder says he might request a lower concentration of a drug for long-term safety.
Barriers: Roadblocks to this treatment approach can be cost, as compounded products must be paid for out-of-pocket, that they may not be available locally, and that they have limited shelf lives, Dr. Pflugfelder explains.
COUNSELING PATIENTS ON ALTERNATIVE TREATMENTS
Because patients are often eager for an effective solution by the time that they are offered “out-of-the-box” options, Dr. Pflugfelder says that overall compliance is good. Even so, it still helps to set patients up for success by walking them through usage recommendations.
Dr. Galor says she accomplishes this goal by making sure to tell patients that, although these products are not FDA approved, they are used frequently and have a good long-term track record.
“Other than that, we counsel patients on the same points as any other prescribed product — discussing the risks, the benefits, and the alternatives,” she explains. “Then, we’ll walk through the plan of action.”
Access: “There is usually at least one compounding pharmacy in every major city,” he says. In Houston, for example, Dr. Pflugfelder says it has been beneficial to his practice to build a good relationship with a local pharmacy that he trusts.
If such a compounding pharmacy isn’t available in your area, conduct an online search or discuss potential recommendations with colleagues regarding national compounding pharmacies that produce safe, high-quality ophthalmic products at competitive prices. When you find the right pharmacy, you want to stick with it, Dr. Pflugfelder adds.
Compounding pharmacies include ImprimisRx, Ocular Science, and Regenerative Network International.
Anat Galor, MD, MSPH, staff physician at the Miami Veterans Administration Medical Center and associate professor of ophthalmology at Bascom Palmer Eye Institute, in Miami, recommends that doctors consider blood products, should FDA-approved products prove unsuccessful.
Why: Dr. Pflugfelder notes that platelet-rich plasma, in particular, is enriched in growth factors that can have miraculous effects in severe keratoconjunctivitis sicca and nonhealing corneal epithelial defects.
Barrier: The accessibility of blood products differs from state to state, says Dr. Galor, making this a more convenient option for some and far less convenient for others. In Florida, for example, where there is a fair share of part-time residents, issues can arise because blood can’t cross state lines.
Access: With a phlebotomy unit that travels all over Florida, she says patients can have blood drawn at home and have their autologous serum drops delivered directly to their door — a convenience she notes patients appreciate.
Autologous serum tears can be provided by several local eye banks and privately run organizations across the country, notes Dr. Donaldson. Vital Tears (www.vitaltears.org ) is a nationwide organization associated with several labs where blood can be drawn around the country.
Dr. Sheppard says he has had positive results in his practice using an amniotic membrane on patients who have dry eye disease, and that it is almost always covered by insurance.
Why: Amniotic membranes help stop the inflammatory immune process by suppressing T-cell activation, inhibiting giant cell formation and controlling the formation of matrix metalloproteinases (decreasing inflammatory mediators). They also contain growth factors and fibronectin, which can be beneficial in the healing process, says Dr. Donaldson.
Access: Amniotic membranes are readily available through multiple companies, including Prokera (cryopreserved amniotic membrane, BioTissue/TissueTec) and AmbioDisc dehydrated amniotic membrane (Katena). The companies are very helpful in explaining the billable diagnoses required for reimbursement, says Dr. Donaldson.
“Once you get to the regenerative medicine stage, you’re in the realm of patients who have recalcitrant issues with meibomian gland dysfunction, and that problem must be attacked, as well,” notes Dr. Sheppard.
In-office treatments remove any patient compliance issues. These treatments can also be effective to either enhance or “jump start” a patient’s home regimen, adds Dr. Donaldson.
BlephEx (Rysurg), EyeGenie External Lid Retractor, EyeXpress (Holbar Medical Products), iLux (Alcon), Intense Pulsed Light, LipiFlow (Johnson & Johnson), Mibo Thermoflo (Mibo Medical Group), NuLids (NuSight Medical), TearCare (Sight Sciences), and TrueTear (Allergan) are worth a look.
Access: “As you move into this category, you must ask whether you are going to offer all these treatments or just pick one. Your budget and the size of your office is part of that decision, as you do not want one machine to cannibalize another, Dr. Sheppard explains. CP