METHOD OF TREATING DIABETIC MACULAR EDEMA
The present disclosure relates to a method of treating diabetic macular edema in a human subject in need thereof, said method comprising (i) an induction phase of topically administering to an affected eye of said subject, an eye drop formulation comprising 1.5% (w/v) dexamethasone, at a dosing of 5 to 7 drops a day for 3, 4, 5, 6 weeks, followed by, (ii) a maintenance phase of topically administering to an affected eye of said subject, said eye drop formulation comprising 1.5% (w/v) dexamethasone at a daily dosing less frequent than the induction phase for example 1-3 drops.
1 . A method of treating diabetic macular edema (DME) in a human subject in need thereof, comprising
(i) an induction phase of topically administering to an affected eye of the subject, an eye drop formulation comprising 1.5% dexamethasone, at a dosing of 5, 6, or 7 drops a day, followed by,
(ii) a maintenance phase of topically administering to the affected eye of the subject, the eye drop formulation at a dosing of 1, 2, or 3, drops a day;
wherein the eye drop formulation further comprises:
−12% to 16% of γ-cyclodextrin;
−2% to 2.7% of a poloxamer;
−0% to 0.1% of a chelating agent;
−0% to 1% of an electrolyte;
−0% to 0.6% of an antioxidant;
and wherein the pH of the eye drop formulation is between 4.7 and 6.0; and
the % are % by weight based on the volume of the eye drop formulation.
2 . The method of claim 1 , wherein the eye drop formulation is a microsuspension comprising solid complexes of dexamethasone and γ-cyclodextrin.
3 . The method of claim 2 , wherein the solid complexes are microparticles with a diameter D50 ranging from 1 μm to 20 μm.
4 . The method of claim 3 , wherein the antioxidant is sodium thiosulfate.
5 . The method of claim 4 , wherein eye drop formulation comprises sodium thiosulfate at a concentration of 0.1% to 0.4%.
6 . The method of claim 5 , wherein the eye drop formulation is in a plastic vial.
7 . The method of claim 6 , wherein the induction phase comprises topically administering the eye drop formulation at a dosing of 5, 6, or 7 drops a day for a period ranging from 5 days to up to 6 weeks.
8 . The method of claim 7 , wherein the induction phase comprises topically administering the eye drop formulation at a dosing of 6 drops a day.
9 . The method of claim 8 , wherein the maintenance phase comprises topically administering the eye drop formulation at a dosing of 1, 2, or 3 drops a day for a period of at least 3 weeks.
10 . The method of claim 9 , wherein the maintenance phase comprises topically administering the eye drop formulation at a dosing of 3 drops a day.
11 . The method of claim 1 , wherein the maintenance phase comprises topically administering the eye drop formulation at a dosing of 1, 2, or 3 drops a day for a period of at least 3 weeks.
12 . The method of claim 11 , wherein the maintenance phase comprises topically administering the eye drop formulation at a dosing of 3 drops a day.
13 . The method of claim 1 , wherein the induction phase comprises topically administering the eye drop formulation at a dosing of 5, 6, or 7 drops a day for a period ranging from 5 days to up to 6 weeks.
14 . The method of claim 13 , wherein the induction phase comprises topically administering the eye drop formulation at a dosing of 6 drops a day.
15 . The method of claim 14 , wherein the maintenance phase comprises topically administering the eye drop formulation at a dosing of 1, 2, or 3 drops a day for a period of at least 3 weeks.
16 . The method of claim 15 , wherein the maintenance phase comprises topically administering the eye drop formulation at a dosing of 3 drops a day.
17 . The method of claim 1 , wherein the subject has an inadequate response to a VEGF inhibitor treatment.
18 . The method of claim 1 , wherein the subject is VEGF inhibitor naïve, with retinal thickening in the affected eye due to diabetic macular edema.
19 . The method of claim 1 , wherein the mean ETDRS Best Corrected Visual Acuity is improved to at least 5 ETDRS letters at the end of the induction phase in the subject suffering from DME as compared to baseline.
20 . The method of claim 1 , wherein the mean ETDRS Best Corrected Visual Acuity is improved to at least 7 ETDRS letters at the end of the induction phase in the subject suffering from DME as compared to baseline.
21 . The method of claim 1 , wherein the central subfield thickness (CST) is reduced by at least 50 μm as measured from baseline, after 6 weeks of treatment in the subject suffering from DME.
22 . The method of claim 1 , wherein the eye drop formulation is preservative free.
23 . The method of claim 1 , wherein the chelating agent is 0.1% disodium edetate.
24 . The method of claim 1 , wherein the electrolyte is sodium chloride.
25 . The method of claim 1 , wherein the antioxidant is sodium thiosulfate.
26 . The method of claim 25 , wherein the eye drop formulation comprises sodium thiosulfate at a concentration of 0.1% to 0.4%.
27 . The method of claim 25 , wherein the eye drop formulation comprises sodium thiosulfate at a concentration of about 0.3%.
28 . The method of claim 1 , wherein the eye drop formulation is a microsuspension comprising solid complexes with a diameter D50 ranging from 1 μm to 10 μm.