Transcript Dias nummer 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.
2.
3.
Fox RI et al.: Beneficial effect of artificial tears made
with autologous serum in patients with KCS. Arthritis
Rheum 1984; 27: 459-461
Tsubota K et al.: Treatment of dry eye with autologous
serum i Sjøgren`s syndrome.
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.
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