world cornea congres 20101 ready-made allogenic serum eye drops for severe dry eye disease. hanne...
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World Cornea Congres 2010 1
Ready-made allogenic serum eye drops for severe dry eye disease.
Hanne Olsen Julian, MD, Ph.D.Henrik Bom Olesen, MD.
Morten Bagge Hansen, MD, Dr.Msc. Lene Harritshøj, MD
Rigshospitalet, Copenhagen, Denmark.
The authors have no financial interest.in the subject matter this poster.
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Purpose
• To overcome the difficulties with preparation of autologous serum drops, a production line based on donor serum of unrelated AB0 blood type identical Danish donors was set up. Efficacy and safety was evaluated in 22 patients with severe ocular surface disorders as an alternative to conventional medical therapy.
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Methods.
• Serum donors were regular volunteer male donors tested for HIV 1 + 2, Hepatitis B and C according to regulations of blood donations in Denmark. Production of serum eye drops complied with good manucfacturing practices. Serum was diluted to 20% and stored at -25°C (-13° F). Frozen AB0 matched serum drops in lots of 14 bottles were provided from the blood-bank upon request within 30 minutes (fig.1 &2).
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Methods, continued.
• During the test period 22 patients with severe dry eye disease refractory to conventional therapy were treated with allogenic serum eye drops from two to four weeks. Eye drops were applied 6 times/day. Patients were examined at day 0, day 15 and day 30.
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Fig.1
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Fig. 2
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Results.
• Twenty-two patients completed two or four weeks of treatment. No side effects were observed.
• Fourteen patients (63%) reported beneficial effects on subjective symptoms.
• In 12 patients (55%) ocular surface changes improved on slit-lamp examination.
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Results, continued
• Patients with kerato-conjunctivitis sicca had the highest rate of succes with subjective relief in 10 of 11 cases.
• Partial or full healing of corneal changes was found in 9 of 11 cases.
• Eyes with corrosion due to herpes experienced no effect of serum treatment.
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Conclusions.
• Ready-made AB0 matched allogenic serum drops is a safe treatment of severe dry eye disease. No side-effects were observed. Therapeutic efficacy is comparable to previous reports (1,2) on autologous serum drops. This novel production and treatment principle greatly increases the availability to patients who might benefice from topical serum treatment.
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References
1. Fox RI et al.: Beneficial effect of artificial tears made with autologous serum in patients with KCS. Arthritis Rheum 1984; 27: 459-461
2. Tsubota K et al.: Treatment of dry eye with autologous serum i Sjøgren`s syndrome.
3. Rocha et al.: GVHD dry eyes treated with autologous serum tears.
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Contact information
• Hanne Olsen Julian, MD, Ph.D.
Denmark.
Mail: [email protected]
Use of allogenic eye drops has not been approved by the U.S. FDA.