# US 2026/0091084 A1 · Ophthalmic composition for treatment of dry eye disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2026/0091084 A1 - Document ID: US20260091084A1 - Status: Published application - Kind: A1 - Application number: 19/413,977 - Filed: 2025-12-09 - Published: 2026-04-02 - Earliest claimed: 2016-12-23 - Assignees: Novaliq GmbH - Applicants: Novaliq GmbH - Inventors: Markus BEIER; Jörg HAISSER; Alice MEIDES; Sonja KRÖSSER; Hartmut VOSS; Frank LÖSCHER; Bernhard GÜNTHER - Web page: https://patentgrep.com/patent/US20260091084A1 ## CPC - A61K 38/13: Cyclosporins - A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) - A61K 9/0048: {Eye, e.g. artificial tears} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 31/00: Medicinal preparations containing organic active ingredients - A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61P 27/02: Ophthalmic agents - A61J 1/067: {Flexible ampoules, the contents of which are expelled by squeezing} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The invention provides pharmaceutical compositions comprising about 0.05 to 0.1% (w/v) cyclosporine dissolved in 1-perfluorobutyl-pentane for use in the topical treatment of dry eye disease and provides for dosing and treatment methods thereof. The invention further provides kits comprising such compositions. ## Claims ### Claim at position 1 -15. (canceled) ### Claim 16 A method for treating dry eye disease, the method comprising the step of topically administering to a human patient in need thereof an ophthalmic composition consisting of cyclosporine, 1-perfluorobutylpentane, 2-perfluorobutylpentane, and ethanol; wherein the cyclosporine is present in an amount of 0.1% (w/v), the 1-perfluorobutylpentane is present in an amount of at least 97% (w/w), the 2-perfluorobutylpentane is present in an amount of up to 2% (w/w), and the ethanol is present in an amount of up to 1.0% (w/w); wherein the composition is administered twice per day per eye as a single drop having a volume of about 10 μl. ### Claim 17 (depends on 16) The method according to claim 16, wherein the composition comprises up to 1% (w/w) of 2-perfluorobutylpentane. ### Claim 18 (depends on 16) The method according to claim 16, wherein the composition comprises up to 0.5% (w/w) of 2-perfluorobutylpentane. ### Claim 19 (depends on 16) The method according to claim 16, wherein the dry eye disease is moderate to severe dry eye disease. ### Claim 20 (depends on 16) The method according to claim 16, wherein the patient is not responsive to treatment with artificial tears. ### Claim 21 (depends on 19) The method according to claim 19, wherein the moderate to severe dry eye disease is characterized by at least one or a combination of the following: i) a total corneal fluorescein staining score of >6; ii) being symptomatic with a score of >40 on the dryness visual analogue scale (VAS); iii) a score >20 on the Ocular Surface Disease Index (OSDI); and iv) a Schirmer's Test I score of >2 mm and <8 mm. ### Claim 22 (depends on 16) The method according to claim 16, wherein the patient is characterized by having at least one eye with: i) a score of >40 on the dryness visual analogue scale (VAS); ii) a total corneal fluorescein staining score of >6; iii) a total lissamine green conjunctival staining score of >2; or iv) a Schirmer's Test I score >2 mm and <8 mm. ### Claim 23 (depends on 16) The method according to claim 16, wherein the patient experiences symptoms selected from blurring, pain, and irritation, or corneal surface damage. ### Claim 24 (depends on 16) The method according to claim 16, wherein the amount of cyclosporine administered in a single dose per eye is about 10 μg. ### Claim 25 (depends on 16) The method according to claim 16, wherein the total daily dosage of cyclosporine administered per eye is about 20 μg. ### Claim 26 (depends on 16) The method according to claim 16, wherein an onset of action is achieved within about 2 to 4 weeks. ### Claim 27 (depends on 16) The method according to claim 16, wherein the dry eye disease is characterized by one or more of tear hyperosmolarity, tear film instability, or abnormalities in the lipid composition of the tear film. ### Claim 28 (depends on 16) The method according to claim 16, wherein the dry eye disease is aqueous deficient dry eye disease. ### Claim 29 (depends on 16) The method according to claim 16, wherein the dry eye disease is evaporative dry eye disease. ### Claim 30 (depends on 16) The method according to claim 16, wherein the dry eye disease is caused by or associated with Meibomian gland dysfunction. ### Claim 31 (depends on 16) The method according to claim 16, wherein the dry eye disease is caused by or associated with allergic conjunctivitis. ### Claim 32 (depends on 16) The method according to claim 16, wherein the patient is characterized by having at least one eye with a Schirmer's Test I score >2 mm and <8 mm. ### Claim 33 (depends on 16) The method according to claim 16, wherein the patient has at least one eye with a total corneal fluorescein staining score of at least 6, or a central corneal fluorescein staining score of at least 1. ### Claim 34 (depends on 16) The method according to claim 16, wherein the patient has at least one eye with a total lissamine green conjunctival staining score of at least 2. ### Claim 35 (depends on 16) The method according to claim 16, wherein the patient is characterized by suppressed tear production. ### Claim 36 (depends on 16) The method according to claim 16, wherein the patient suffers from reading impairment caused by increased ocular discomfort during, or as a consequent to the task of reading, and/or difficulty in visualizing or perceiving characters while reading. ### Claim 37 (depends on 16) The method according to claim 16, wherein the method provides a reduction in corneal fluorescein and/or conjunctival lissamine green staining in the patient. ### Claim 38 (depends on 16) The method according to claim 16, wherein the method provides a reduction in corneal and/or conjunctival inflammation.