Utilization of autologous serum eye drops (ASEDs) for ocular surface disease (OSD) has been around for decades. I’ve come to realize that many of us, including formerly myself, may not be prescribing them because of the variables associated with doing so. As a result, this month’s column reviews the value of ASEDs, and how to acquire them.

The value of ASEDs
When we hear ASEDs, most of us think of persistent epithelial defects, underlying immunological disorders, such Sjögren’s syndrome, graft vs. host disease, or neurotrophic keratitis. This makes sense, as ASEDs provide ocular surface lubrication, while fostering epithelial healing and corneal nerve function.

While ASEDs are helpful for these more severe dry eye disease (DED) patients, they can be used in other applications. In truth, ASEDs are beneficial for patients at any level of DED, particularly in those patients who have any sensitivities or allergies to prescription DED medication ingredients. This is because serum, which is the liquid component of our blood, is similar to tears in terms of pH and osmolarity, and contain components, such as growth factors, vitamin A, lysozyme, and fibronectin.^1,2 To make ASEDs, the patient’s collected serum is diluted with sterile saline in concentrations ranging between 20% to 100%.¹ 

ASEDs cost an average of $250 to $500 out of pocket for a 3-month supply, depending on concentration, dosage, and where they are obtained. In some cases, ASEDs can be less expensive than prescription DED treatments. 

I find the idea of ASEDs overall well received by patients, who understand the idea that tears made from their own body carry nutrients and other good things the ocular surface needs to properly function.

To explain ASEDs’ value to patients, I say something like, “Ms. Smith, I want to start you on a drop for your ocular surface disease. This drop is actually made from your own blood, which is spun to extract serum that contains lots of nutrients and growth factors that your ocular surface needs to function. While the serum drops are not covered by your insurance, you can use your FSA/HSA to pay for this treatment. You will receive a 3-month supply of bottles, which must be frozen until use. One bottle a week is removed for use and must always be refrigerated, as the drops are preservative-free.”

Pro tip: Patients concerned about how to keep their ASEDs cold all day while out of the house or traveling? Have them use a travel mug and put a freezer pack inside to help keep the drops cold. This is easier, smaller, and more effective than a lunch bag!

Acquiring ASEDs
ASEDs are a blood product, not a pharmaceutical, therefore they are not currently regulated by the FDA. With current concerns regarding ocular drops, it is important to be mindful of manufacturing processes. State authorities have recently been implementing stricter protocols for production of blood products, including ASEDs, to help combat these concerns and inconsistencies.

Only a few compounding pharmacies with on-staff phlebologists or hospital-affiliated labs currently offer the service of ASEDs production. Call to find out whether they are able to provide this service. Alternatively, you could discuss initiating this service with your local compounding pharmacy. (The following can provide the local compounding pharmacy with the recipe: bit.ly/OM2403Autolo
gousSerum). If using a local practice producing ASEDs, ask to view their process and the manufacturing site, as no current oversight ensures safety of manufacturing in these cases. Another option is Vital Tears, a company that creates the ASEDs and handles the administrative processes associated with blood acquisition and ASEDs delivery. (See vitaltears.com.)

Concentrations of the serum range widely, with the most prescribed being 20% to 25%. Recent literature indicates concentrations of 40% to 50% are most effective.³ ASEDs above 60% contain large amounts of transforming growth factor beta, which may suppress epithelial wound healing.⁴

Maybe later?
Platelet rich plasma, or PRP, has a higher concentration of platelets vs. ASEDs, resulting in what is believed to be a greater immunomodulatory and anti-inflammatory profile. In fact, PRP is shown to provide a significant improvement in symptoms.⁴ Obtaining PRP can be difficult, as there is considerable variation in their development, they can be costly, and just a few locations nationwide produce it. OM

References

1. Vazirani J, Sridhar U, Gokhale N, Doddigarla VR, Sharma S, Basu S. Autologous serum eye drops in dry eye disease: Preferred practice pattern guidelines.Indian Journal of Ophthalmology. 2023;71(4):1357-1363. doi: 10.4103/IJO.IJO_2756_22.

2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006.

3. Semeraro F, Forbice E, Braga O, Bova A, Di Salvatore A, Azzolini C. Evaluation of the efficacy of 50% autologous serum eye drops in different ocular surface pathologies. Biomed Res Int. 2014;2014;826970. doi: 10.1155/2014/826970.

4. Wróbel-Dudzińska D, Przekora A, Kazimierczak P, et al. The comparison between the composition of 100% autologous serum and 100% platelet-rich plasma eye drops and their impact on the treatment effectiveness of dry eye disease in primary Sjögren’s syndrome. J Clin Med. 2023;12(9):3126. doi: 10.3390/jcm12093126.

Dr. Koetting is a clinical instructor at the University of Colorado School of Medicine. She is a fellow of the American Academy of Optometry, diplomate of the American Board of Optometry, an active American Optometric Association member, and she consults for multiple companies. Email her at Dr.CeceliaKoetting@gmail.com.