Treatment of ocular disease
The present invention is in the field of ocular disease therapy. In particular, the invention relates to a composition comprising pimecrolimus for use in the topical treatment of moderate to severe blepharitis, in particular in a patient group comprising subjects with a clinical diagnosis of moderate to severe blepharitis, wherein the subjects to be treated have signs and symptoms of moderate to severe blepharitis characterised by swelling of the eyelid margin, ocular debris and ocular discomfort. In particular, the present invention relates to an ophthalmic composition that shows a high patient acceptance and a clinically meaningful improvement in the signs and symptoms of treated patients.
1 . A method of treating a patient having moderate to severe blepharitis, the method comprising administering to said patient a composition comprising between 0.05% (wt/wt) and 0.6% (wt/wt) pimecrolimus;
wherein said patient has the following signs and symptoms of moderate to severe blepharitis:
(i) a score of at least 2 on swelling of the eyelid margin on a 0-4 scale;
(ii) a score of at least 2 on ocular debris on a 0-4 scale; and
(iii) a symptom score of at least 40 mm on ocular discomfort on a 100 mm visual analogue scale.
2 . The method according to claim 1 , wherein the composition is administered to the eyelid and/or eyelid margin of said patient.
3 . The method according to claim 2 , wherein a unit dosage of the composition is administered once, twice, three times, or four times a day.
4 . The method according to claim 1 , wherein said composition comprises between 0.1% (wt/wt) and 0.4% (wt/wt) pimecrolimus.
5 . The method according to claim 4 , wherein said composition comprises 0.3% (wt/wt) pimecrolimus.
6 . The method according to claim 1 , wherein said composition is formulated as an ointment having an ointment base selected from ophthalmically acceptable oil and fat bases.
7 . The method according to claim 6 , wherein said composition further comprises a medium-chain triglyceride and a microcrystalline wax.
8 . The method according to claim 7 , wherein said medium-chain triglyceride is present in an amount between 30% (wt/wt) and 60% (wt/wt).
9 . The method according to claim 8 , wherein said medium-chain triglyceride comprises caprylic and/or capric acid.
10 . The method according to claim 7 , wherein said microcrystalline wax is present in an amount between 3% (wt/wt) and 10% (wt/wt).
11 . The method according to claim 7 , wherein said composition comprises 0.3% (wt/wt) pimecrolimus, 50% (wt/wt) medium-chain triglyceride, and 6% (wt/wt) microcrystalline wax.
12 . The method according to claim 11 , wherein a unit dosage of said composition is administered twice a day.
13 . The method according to claim 3 , wherein said treatment is carried out for at least 2 weeks.
14 . A method of treating a patient having chronic blepharitis, which comprises administering to the eyelid and/or eyelid margin of said patient a composition comprising between 0.1% (wt/wt) and 0.4% (wt/wt) of pimecrolimus;
wherein said blepharitis is moderate to severe blepharitis such that the patient has:
(i) a score of at least 2 on swelling of the eyelid margin on a 0-4 scale;
(ii) a score of at least 2 on ocular debris on a 0-4 scale; and
(iii) a symptom score of at least 40 mm on ocular discomfort on a 100 mm visual analogue scale.
15 . The method according to claim 14 , wherein said composition is administered once, twice, three times, or four times per day.
16 . The method according to claim 15 , wherein said treatment is carried out for at least 2 weeks.