Summary report on authorisation – Serum autolog KSGR, eye drops

Serum autolog KSGR, eye drops® (active substance: autologous human serum)

The medicinal product "Serum autolog KSGR, eye drops" contains the active substance autologous human serum (blood serum), which is prepared from the patient's own blood. It is used to treat dry eye (keratoconjunctivitis sicca) in adults who do not experience adequate symptom relief with other authorised treatments. Dry eye is a common condition in which the natural tears are no longer able to adequately perform their protective function for the ocular surface. This can lead to symptoms and damage to the ocular surface and adversely affect quality of life.

"Serum autolog KSGR, eye drops" is a prescription-only medicine that is only prescribed by a doctor specialising in ophthalmology. These eye drops contain 100% autologous serum.

The efficacy of "Serum autolog KSGR, eye drops" was investigated by means of several systematic literature reviews, meta-analyses and a Cochrane review[1], all of which involved the use of similar products. The most important basis was provided by five clinical trials involving a total of 92 patients with dry eye. The trials suggest that autologous serum eye drops can relieve symptoms in the first two weeks of treatment compared to artificial tears. However, the available trial data are still limited and disparate due to the variety of manufacturing processes used for the serum eye drops, dosages and the investigated patient groups. Moreover, no clear benefit has been demonstrated for a longer-term treatment.

"Serum autolog KSGR, eye drops" may only be used by the person from whose own blood the medicinal product was prepared. It may not be used, for example, if the patient has certain eye infections or is hypersensitive to the active substance. In order to minimise the risk of microbial contamination and a consequent eye infection, the eye drops must be used carefully and in accordance with the storage directions and instructions for use. Eye irritation or burning, a feeling of the eyelids sticking together and blurred vision can often occur temporarily after administration.

There is a medical need for additional treatment options for patients with dry eye whose symptoms cannot be adequately relieved by the currently available authorised treatments. In such cases, autologous serum eye drops can serve as an alternative treatment option. Although the scientific evidence is limited and the long-term benefit has not been clearly demonstrated, the risk is manageable overall and can be controlled by suitable manufacturing, storage and administration measures, and many years of experience have been accumulated with this treatment.