Health Problem: Dry eye disease (DED) is a group of tear film disorders attributed to reduced tear production or excessive tear evaporation and associated with ocular discomfort, visual symptoms, and possible disease of the ocular surface. DED is estimated to be present in 25% of all adults seen in ophthalmology and optometry clinics and in approximately 5 million adults ≥ 50 years of age. The clinical presentation with DED may include burning, stinging, a scratchy sensation, discharge, dryness, pain, visual disability, and redness followed by excess tearing.

Technology Description: Autologous Serum Eye Drops (ASED) solution is prepared from a blood sample drawn from the recipient. The sample is allowed to clot, is centrifuged, and then diluted. The ASED preparation is kept frozen; stability when frozen is considered to be ≤ 3 months. A common dosing regimen is 4 times per day at a concentration of 20%, 50%, or 100%.

Controversy: Treatment of DED is based on symptom management; DED is not curable and chronic therapy is required. Although artificial tears are a mainstay of DED treatment, the results may not be optimal and are often ineffective. Theoretically, ASED has potential to function as a lacrimal substitute with the added benefit of biochemical components. Controversies in the use of ASED for the treatment of DED include the optimal concentration of ASED (20% to 100%) and the duration of therapy.

Key Questions:

  • Is the use of ASED effective in treating DED in adults?
  • How does ASED therapy compare with other treatments for DED in adults?
  • Is ASED therapy safe for the treatment of DED in adults?
  • Have definitive patient selection criteria been identified for the use of ASED therapy in the treatment of DED in adults?

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