METHODS FOR THE TREATMENT OF PRESBYOPIA

1 . An ophthalmological composition for the treatment of presbyopia comprising:

a muscarinic agonist and brimonidine in the form of a salt;

wherein the muscarinic agonist is aceclidine in the form of a salt at an aceclidine concentration from about 1% w/v to about 2% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v;

wherein the brimonidine salt is present at a brimonidine concentration from about 0.07% w/v to about 0.08% w/v;

wherein w/v denotes weight by volume;

wherein the term about encompasses plus or minus 10% of the recited amount.

2 . The ophthalmological composition of claim 1 , wherein the muscarinic agonist is aceclidine in the form of a hydrochloride salt at an aceclidine concentration from about 1.40% w/v to about 1.75% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v.

3 . The ophthalmological composition of claim 1 , wherein the muscarinic agonist is aceclidine in the form of a hydrochloride salt at an aceclidine concentration from 1.35% w/v to 1.55% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v.

4 . The ophthalmological composition of claim 1 , wherein the muscarinic agonist is aceclidine in the form of a hydrochloride salt at an aceclidine concentration from 1.40% w/v to 1.45% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v.

5 . The ophthalmological composition of claim 1 , wherein the ophthalmological composition further comprises one or more excipients selected from the group consisting of one or more nonionic surfactants, one or more viscosity agents, and a polyol.

6 . The ophthalmological composition of claim 5 , wherein:

the one or more nonionic surfactants are selected from the group consisting of a polysorbate, tyloxapol, a poloxamer, a cyclodextrin, vitamin E TPGS, a polyoxyl castor oil, a polyoxyl stearate, polyethylene glycol, a polyoxyethylene glycol alkyl ether, 2-[[10,13-dimethyl-17-(6-methylheptan-2-yl)-2,3,4,7,8,9,11, 12, 14, 15, 16, 17-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl]oxy]ethanol a sorbitan, an octyl phenol ethoxylate, a nonoxynol, lauryl glucoside, cocamide, cetyl alcohol, glycerol monostearate, an alkyl polyglycoside, and an octoxynol;

the one or more viscosity agents are selected from the group consisting of cellulose, a cellulose derivative, glycerol, a dextran, gelatin, polyethylene glycol, hyaluronate, a carbomer, polyvinyl alcohol, polyvinyl pyrrolidone, and a gum; and

the polyol is selected from the group consisting of mannitol, glycerol, erythritol, lactitol, xylitol, sorbitol, isosorbide, ethylene glycol, propylene glycol, maltitol, threitol, arabitol and ribitol.

7 . The ophthalmological composition of claim 5 , wherein:

the one or more nonionic surfactants is a polysorbate;

the one or more viscosity agents are cellulose derivatives; and

the polyol is mannitol.

8 . The ophthalmological composition of claim 5 , wherein:

the one or more nonionic surfactants is polysorbate 80;

the one or more viscosity agents is carboxymethyl cellulose or hydroxypropylmethyl cellulose; and

the polyol is mannitol.

9 . A method of treating presbyopia comprising administering an eye drop ophthalmological composition to an eye of a human in need of presbyopia treatment, wherein the eye drop ophthalmological composition comprises:

a muscarinic agonist and brimonidine in the form of a salt;

wherein the muscarinic agonist is aceclidine in the form of a salt at an aceclidine concentration from about 1% w/v to about 2% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v;

wherein the brimonidine salt is present at a brimonidine concentration from about 0.07% w/v to about 0.08% w/v;

wherein w/v denotes weight by volume; and

wherein the term about encompasses plus or minus 10% of the recited amount.

10 . The method of claim 9 , wherein the muscarinic agonist is aceclidine in the form of a hydrochloride salt at an aceclidine concentration from 1.35% w/v to 1.55% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v.

11 . The method of claim 9 , wherein the muscarinic agonist is aceclidine in the form of a hydrochloride salt at an aceclidine concentration from 1.35% w/v to 1.45% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v.

12 . The method of claim 9 , wherein the eye drop ophthalmological composition further comprises one or more excipients selected from the group consisting of one or more nonionic surfactants, one or more viscosity agents and a polyol.

13 . The method of claim 12 , wherein:

the one or more nonionic surfactants are selected from the group consisting of a polysorbate, tyloxapol, a poloxamer, a cyclodextrin, vitamin E TPGS, a polyoxyl castor oil, a polyoxyl stearate, polyethylene glycol, a polyoxyethylene glycol alkyl ether, 2-[[10,13-dimethyl-17-(6-methylheptan-2-yl)-2,3,4,7,8,9,11, 12, 14, 15, 16, 17-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl]oxy]ethanol a sorbitan, an octyl phenol ethoxylate, a nonoxynol, lauryl glucoside, cocamide, cetyl alcohol, glycerol monostearate, an alkyl polyglycoside, and an octoxynol;

the one or more viscosity agents are selected from the group consisting of cellulose, a cellulose derivative, glycerol, a dextran, gelatin, polyethylene glycol, hyaluronate, a carbomer, polyvinyl alcohol, polyvinyl pyrrolidone, and a gum; and

the polyol is selected from the group consisting of mannitol, glycerol, erythritol, lactitol, xylitol, sorbitol, isosorbide, ethylene glycol, propylene glycol, maltitol, threitol, arabitol and ribitol.

14 . The method of claim 12 , wherein:

the one or more nonionic surfactants is a polysorbate;

the one or more viscosity agents are cellulose derivatives; and

the polyol is mannitol.

15 . The method of claim 12 , wherein:

the one or more nonionic surfactants is polysorbate 80;

the one or more viscosity agents is carboxymethyl cellulose or hydroxypropylmethyl cellulose; and

the polyol is mannitol.

16 . The method of claim 9 , wherein the administering comprises administering 1 drop of the eye drop ophthalmological composition to each eye of the human, or administering 2 drops of the ophthalmological composition to each eye of the human.

17 . A method of treating presbyopia, irregular astigmatism, and/or refractive error, comprising administering an eye drop ophthalmological composition to an eye of a human in need of presbyopia treatment, wherein the eye drop ophthalmological composition comprises:

a muscarinic agonist and brimonidine in the form of a salt;

wherein the muscarinic agonist is aceclidine in the form of a salt at an aceclidine concentration from about 1% w/v to about 2% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v;

wherein the brimonidine salt is present at a brimonidine concentration from about 0.07% w/v to about 0.08% w/v;

wherein administration occurs 2 or more times within 24 hours of initial administration;

wherein each administration comprises administering one or more drops of the eye drop ophthalmological composition;

wherein w/v denotes weight by volume; and

wherein the term about encompasses plus or minus 10% of the recited amount.

18 . The method of claim 17 , wherein administration occurs 2 or more times within 1 hour of initial administration.

19 . The method of claim 17 , wherein administration occurs 2 or more times within 5 minutes of initial administration.

20 . The method of claim 17 , wherein the muscarinic agonist is aceclidine in the form of a hydrochloride salt at an aceclidine concentration from 1.35% w/v to 1.55% w/v, or carbachol at a concentration from about 2% w/v to about 2.75% w/v; and

wherein the eye drop ophthalmological composition further comprises one or more excipients selected from the group consisting of one or more nonionic surfactants, one or more viscosity agents, and a polyol.