Treatments for ocular surface disorders
The inventions relate to compounds and compositions comprising connexin modulators and their use in dose regimens for the treatment of non-healing or persistent ocular surface or corneal defects and disorders.
1 . A method for treating a subject for a non-healing ocular surface defect, comprising administering to the eye of the subject a therapeutically effective amount of a composition comprising a connexin 43 modulator, wherein the connexin 43 modulator is lufepirsen (SEQ ID NO: 1) and the composition is administered at a dose of about 0.006 wt. % lufepirsen or 0.06 wt. % lufepirsen at least once on day 1, at least once on day 2, and at least once on about day 14.
2 . The method of claim 1 , wherein the non-healing ocular surface defect is a persistent corneal epithelial defect or a persistent epithelial defect.
3 . The method of claim 1 , wherein the non-healing ocular surface defect results from a chemical injury, a thermal injury, or inflammation.
4 . The method of claim 1 , wherein the subject has an amniotic membrane graft.
5 . The method of claim 2 , wherein the non-healing ocular surface defect is the persistent epithelial defect.
6 . The method of claim 2 , wherein the non-healing ocular surface defect is the persistent corneal epithelial defect.
7 . The method of claim 1 , wherein the connexin 43 modulator modulates connexin 43 in the cornea.
8 . The method of claim 1 , wherein said connexin 43 modulator is administered by topical administration.
9 . The method of claim 1 , further comprising the step of placing a bandage contact lens over the non-healing ocular surface defect.
10 . The method of claim 6 , wherein the connexin 43 modulator is formulated with a pluronic gel.
11 . A method for treating a subject for a persistent corneal epithelial defect, comprising administering to the eye of the subject a composition comprising about 0.06% or about 0.006% lufepirsen on day 1, on day 2, and on about day 14.
12 . The method according to claim 11 , further comprising administering to the subject the composition comprising about 0.06% or about 0.006% lufepirsen on about day 7 and/or on about day 21.
13 . The method according to claim 11 , further comprising administering to the subject the composition comprising about 0.06% or about 0.006% lufepirsen on about day 28 and/or on about day 35.
14 . The method according to claim 12 , further comprising administering to the subject the composition comprising about 0.06% or about 0.006% lufepirsen on about day 28 and/or on about day 35.
15 . A pharmaceutical composition comprising about 0.6 or 0.06 mg/mL lufepirsen, about 226.9 mg/mL poloxamer 407, about 0.99 mg/mL sodium phosphate dibasic heptahydrate and about 0.25 mg/mL potassium phosphate, monobasic.
16 . The pharmaceutical composition according to claim 15 having a final volume of about 300 μL.
17 . A method for treating a subject for a non-healing ocular surface defect, comprising administering to the eye of the subject the pharmaceutical composition according to claim 16 at least once on day 1, at least once on day 2, and at least once on about day 14.
18 . The method according to claim 17 , further comprising administering said pharmaceutical composition to the eye of the subject on about day 7 and on about day 21.
19 . The method according to claim 18 , further comprising administering said pharmaceutical composition to the eye of the subject on about day 28.
20 . The method according to claim 18 , further comprising administering said pharmaceutical composition to the eye of the subject on about day 35.