Stage 3 Dry Eye Treatments: Autologous Serum

Part 1 of a 4-part Q&A series about advanced dry eye disease treatments.

By Abby Gillogly Harsch, OD, and Nicole Stout, OD; with Richard B. Mangan, OD

Patients with dry eye disease (DED) who have been treated with artificial tears, warm compresses, omega 3 supplements, and prescription medication likely fit into the category of stage 3 DED, which is defined by significant corneal staining and lifestyle activities limited as a result of discomfort.1 According to the Dry Eye Workshop report, the arsenal of treatments for stage 3 DED patients may include one or more of the following: autologous serum (AS), amniotic membrane grafts, punctal cautery, and scleral contact lenses.

We interviewed experts in the field about common questions that arise when use of these advanced treatment options for stage 3 DED is considered. In this installment, Richard B. Mangan, OD, joined us to discuss AS, the use of which involves converting a patient’s blood serum into an ophthalmic drop. These drops consist of components that closely resemble the nutrients found in one’s own tears.

—Abby Gillogly Harsch, OD, and Nicole Stout, OD

In what type of dry eye patient would AS treatment be most beneficial?

It certainly would have a positive effect in patients with aqueous deficient or inflammatory dry eye disease. To my knowledge, it has not been tested in those primarily dealing with evaporative dry eye. In my opinion, patients with level 2 dry eye would benefit from AS tears. However, it is difficult to get patients to transition to this form of treatment until they have tried most of the other topical modalities, such as steroids, cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan), lifitegrast (Xiidra, Shire), punctal occlusion, etc. Therefore, level 3 DED patients are the ones for whom I most often prescribe AS.

What is the dosing schedule for AS?

While it is possible for patients to show improvement on three- or four-times daily dosing, I recommend dosing every 2 to 3 hours. Because there are no preservatives in the AS formulation I prescribe, it is a “use it or lose it” proposition. Remember, patients must throw away a bottle that has been out of the freezer, and instead refrigerated, after 72 hours. For those who choose to put a preservative in the bottle, I would not recommend more than four-times-a-day dosing, as the preservative can have a conflicting effect.

Do you typically recommend that patients continue frequent dosing of artificial tears in addition to AS?

No. Once AS is started, there is no benefit in using commercially produced artificial tear products. In fact, in my experience, the majority of my patients on AS were able to reduce or discontinue topical antiinflammatory products as well. Depending on the severity of their disease and the environment they are likely to be exposed to, I sometimes recommend a topical steroid as an adjunctive or abortive treatment.

What is your recommended follow-up schedule for patients using AS?

In most cases—assuming it is for ocular surface disease and not a wound healing issue—I ask patients to schedule a 1-month follow-up appointment after starting AS tears. Patients are instructed to call and come in sooner should they have any concerns or questions. Considering that most patients get a 3-month supply of tears from a single blood draw, they are asked to schedule a 3-month follow-up appointment as well.

In what time frame do you expect patients to notice improvement of their symptoms on this treatment?

In my experience, patients at the 1-month follow-up appointment are already reporting increased comfort. By 3 months, patients notice improved quality of vision and improved quality of life, while I start to observe clinical signs of improvement (ie, less vital dye staining).

How long should a patient expect to be on this treatment regimen?

When I first started offering AS to my patients, I didn’t know what to expect. I thought the cost might be a financial burden for most patients. I went in with the idea that maybe we could go 3 months on and 3 months off. I was trying to be cost-conscious for my patients. I was amazed at how many did not want to stop using AS drops. Keep in mind that many were on maximum medical therapy, and AS actually provided a cost savings when compared with their previous regimen. For others, it was an added expense that was worth it because quality of life was significantly improved. You know that you are on to something when patients are willing to drive 3 to 4 hours to get their next blood draw and batch of custom tears.

What are the clinical contraindications for this treatment?

All patients are screened for blood pathogens and disease prior to formulation. Assuming the blood work is negative, the patient should be fine using his or her own serum. Of course, it is understood that patients are not to share their serum tears with others.

What are the risks and complications involved for patients using AS?

Risks and reported complications are, thankfully, low. According to Geering et al,2 studies involving 255 patients showed the following complications:

• Peripheral corneal infiltrate and ulcer (n = 1)

• Eyelid eczema (n = 2)

• Microbial keratitis in patients with an epithelial defect (n = 3)

• Increased discomfort or epitheliopathy (n = 5)

• Temporary bacterial conjunctivitis (n = 5)

Cases of scleral vasculitis and melting in rheumatoid arthritis patients were reported, as were cases of immune complex deposition with 100% serum.

Bear in mind that some of these complications may have been due to the underlying disease states rather than a direct side effect of AS eye drops.

What is the most common (positive or negative) feedback you have received from patients on this treatment?

Among the positive responses are “I can’t remember the last time my eyes felt this good!” and “I am no longer afraid to leave the house on cold windy days!”

Among the negative responses (which are rare) I have heard are “I haven’t noticed much improvement from using AS drops.”

Most patients who have the means to stay on AS drops do so. Most patients who do not keep up with the treatment are those who run into a financial barrier.

How do you recommend setting up a laboratory/eye bank/pharmacy to perform the blood draw and/or compound AS?

Thankfully, we are starting to see more and more eye banks understand the concept of AS tears. It all starts with a phone call. Any questions on how to get it set up with a local lab, compounding pharmacy, and/or eye bank can be directed to me via my Facebook page “The Dry Eye Guy” or to my email address.

What clinical pearls can you share regarding this treatment method?

I prefer to prescribe preservative-free AS tears. Because there are no preservatives, I prescribe 2-mL fills in 3-mL bottles. It is important that patients not use their preservative-free AS tears 72 hours after opening them, as the risk of contamination and infection rises significantly. For patients in whom there is a concern for noncompliance (ie, trying to stretch the use of AS drops), I ask them to bring their empty bottles at each visit. This allows me to check whether they are following directions. Patients who visit every 6 months instead of every 3 months should be flagged as trying to stretch the life of the drops. n

1. Behrens A, Doyle JJ, Stern L, et al; Dysfunctional Tear Syndrome Study Group. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006;25(8):900-907.

2. Geerling G, MacLennan S, Hartwig D. Autologous serum eye drops for ocular surface disorders. Br J Ophthalmol. 2004;88(11):1467-1474.

Abby Gillogly Harsch, OD, FSLS
• optometrist, Nittany Eye Associates, State College, Pa.
• financial disclosure: none
aharsch@nittanyeye.com

Nicole Stout, OD
• clinical instructor, University of Waterloo School of Optometry and Vision Science, Waterloo, Ontario
• financial disclosure: none
ncstout@uwaterloo.ca

Richard B. Mangan, OD, FAAO
• private practice, Lexington, Ky.
• financial disclosure: none
eyeam4uk@gmail.com