Claims for Patent: 12,144,889

Summary for Patent: 12,144,889

Title:	Methods of treating allergic conjunctivitis
Abstract:	Disclosed is a sustained release biodegradable intracanalicular insert containing a glucocorticoid dispersed in a hydrogel. The insert is administered to a subject for the treatment of allergic conjunctivitis.
Inventor(s):	Michael Goldstein
Assignee:	Ocular Therapeutix Inc
Application Number:	US17/673,331
Patent Claims:	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.