Methods of treating allergic conjunctivitis

1. A method of treating allergic conjunctivitis in a patient in need thereof, the method comprising administering to the canaliculus of the patient a completely formed sustained release biodegradable intracanalicular insert consisting essentially of dexamethasone, 4-arm20kPEG-SG, trilysine acetate, fluorescein, sodium phosphate monobasic, sodium phosphate dibasic and water;

the insert having an essentially cylindrical shape;

the insert being preservative-free;

wherein the ophthalmic insert releases about 0.4 mg of dexamethasone following administration;

wherein the occurrence of increase in intraocular pressure in a population of allergic conjunctivitis patients is about 3% or less in the population; and

wherein the administration is safe and effective for the treatment of allergic conjunctivitis.

2. The method of claim 1 , wherein the insert provides an ocular itching score of about 1.7 to about 2.1 on Day 8 of use when measured at 3 minutes, 5 minutes or 7 minutes post-challenge as measured using a modified Conjunctival Allergen Challenge Model.

3. A method of treating allergic conjunctivitis in a patient in need thereof, the method comprising administering to the canaliculus of the patient a completely formed sustained release biodegradable intracanalicular insert consisting of dexamethasone, 4-arm20kPEG-SG, trilysine acetate, fluorescein, sodium phosphate monobasic, sodium phosphate dibasic and water;

the insert having an essentially cylindrical shape;

the insert being preservative-free;

wherein the ophthalmic insert releases about 0.4 mg of dexamethasone following administration;

wherein the occurrence of increase in intraocular pressure in a population of allergic conjunctivitis patients is about 3% or less in the population; and

wherein the administration is safe and effective for the treatment of allergic conjunctivitis.

4. A method of treating allergic conjunctivitis in a patient in need thereof, the method comprising administering to the canaliculus of the patient a completely formed sustained release biodegradable intracanalicular insert comprising a hydrogel and dexamethasone having a particle size of less than about 100 μm;

the hydrogel comprising a polymer network comprising one or more crosslinked 4-arm polyethylene glycol units having an average molecular weight of about 20,000 Daltons;

the polymer network being formed by reacting an electrophilic group-containing multi-arm-polymer precursor with a nucleophilic group-containing crosslinking agent;

the electrophilic group-containing multi-arm-polymer precursor comprising 4-arm 20kPEG-SG and the crosslinking agent comprising trilysine acetate;

the insert having an essentially cylindrical shape;

the insert being preservative-free;

the insert in a dry state comprising one or more phosphate, borate or carbonate salt(s);

the insert comprising a visualization agent comprising fluorescein conjugated with trilysine acetate;

wherein the ophthalmic insert releases about 0.4 mg of dexamethasone following administration;

wherein the occurrence of increase in intraocular pressure in a population of allergic conjunctivitis patients is about 3% or less in the population; and

wherein the administration is safe and effective for the treatment of allergic conjunctivitis.

5. A method of treating allergic conjunctivitis in a patient in need thereof, the method comprising administering to the canaliculus of the patient a completely formed sustained release biodegradable intracanalicular insert comprising a hydrogel and dexamethasone;

the hydrogel comprising a polymer network comprising one or more crosslinked 4-arm polyethylene glycol units having an average molecular weight of about 20,000 Daltons;

the polymer network being formed by reacting an electrophilic group-containing multi-arm-polymer precursor with a nucleophilic group-containing crosslinking agent;

the electrophilic group-containing multi-arm-polymer precursor comprising 4-arm 20kPEG-SG and the crosslinking agent comprising trilysine acetate;

the insert having an essentially cylindrical shape;

the insert in a dry state having an average length of about 3 mm;

the insert being preservative-free;

the insert in a dry state comprising one or more phosphate, borate or carbonate salt(s);

the insert comprising a visualization agent comprising fluorescein conjugated with trilysine acetate;

wherein the ophthalmic insert releases about 0.4 mg of dexamethasone following administration;

wherein the occurrence of increase in intraocular pressure in a population of allergic conjunctivitis patients is about 3% or less in the population; and

wherein the administration is safe and effective for the treatment of allergic conjunctivitis.

6. The method of claim 3 , wherein the insert provides an ocular itching score of about 1.7 to about 2.1 on Day 8 of use when measured at 3 minutes, 5 minutes or 7 minutes post-challenge as measured using a modified Conjunctival Allergen Challenge Model.

7. The method of claim 4 , wherein the insert provides an ocular itching score of about 1.7 to about 2.1 on Day 8 of use when measured at 3 minutes, 5 minutes or 7 minutes post-challenge as measured using a modified Conjunctival Allergen Challenge Model.

8. The method of claim 5 , wherein the insert provides an ocular itching score of about 1.7 to about 2.1 on Day 8 of use when measured at 3 minutes, 5 minutes or 7 minutes post-challenge as measured using a modified Conjunctival Allergen Challenge Model.