SED are prepared from serum for use by eligible patients suffering from severe ocular surface disorders who do not respond to conventional therapies.
SED are presented in 1.5mL aliquots, in dispensing vials that enable topical application of the SED to the ocular surface. Vials are labelled and packaged into cartons containing up to 36 vials. One vial is intended for one day’s use. The content of each carton is sufficient for one month of therapeutic treatment.
SED are typically issued to patients as a six-month treatment course (six cartons) and intended for storage and use by patients at home.
SED have a shelf life of 12 months from date of whole blood collection when maintained in frozen state (≤ -15ºC). They do not contain any anti-microbial preservatives, so once thawed for use, must be stored in a refrigerated environment, and discarded within 24 hours of thawing.
Typical unit content and specifications
The typical unit content data is derived from Lifeblood process control testing. For each parameter, the mean value (± 1 SD) and specification is shown.
Data is for the period 1 November 2022 to 31 August 2023.
Parameter | Mean | Specification |
Total protein (g/L) | 13 | 11-17 |
Bacterial contamination | No growth | No growth |
Availability
SED are only available to patients who meet strict clinical eligibility criteria. They can only be requested by an ophthalmologist.
SED are currently offered as autologous (made from the patient’s own blood) or via patient-tailored exemption.
Lifeblood is currently working towards the introduction of allogeneic serum eyedrops (made from volunteer male AB donor blood) which will replace both current SED products.
Modifications
There are no modifications available for serum eyedrops.