Combination for use in ophthalmology

Patent metadata

Field	Value
Publication number	US-2026041733-A1
Application number	US-202319099530-A
Country	US
Kind code	A1
Filing date	Jul 27, 2023
Priority date	Jul 29, 2022
Publication date	Feb 12, 2026
Grant date	—

Abstract

The present invention relates to a combination of nerve growth factor and sesamin, and uses thereof in the treatment of ophthalmic disorders.

First claim

1 . A combination of nerve growth factor (NGF) and sesamin, for use by topical administration in the treatment of an ocular disorder known to be treatable by NGF.

2 . An ophthalmic composition comprising nerve growth factor (NGF), sesamin, and at least one ophthalmically acceptable excipient.

3 . A kit comprising:
a) an ophthalmic composition comprising nerve growth factor (NGF), and b) an ophthalmic composition comprising sesamin.

4 . A combination for use according to claim 1 , an ophthalmic composition according to claim 2 or a kit according to claim 3 , wherein said NGF has the aminoacid sequence of SEQ. ID NO.1 or of SEQ ID NO. 2.

5 . A combination for use according to claim 1 or 4 , an ophthalmic composition according to claim 2 or 4 or a kit according to claim 3 or 4 , wherein said NGF is recombinant human NGF.

6 . A combination for use according to claim 1, 4 or 5 , an ophthalmic composition according to claim 2, 4 or 5 or a kit according to claim 3, 4 or 5 , wherein said NGF has a purity higher than 70%, more preferably higher than 80% w/w, higher than 90% w/w, higher than 95% w/w, higher than 98% w/w or higher than 99% w/w.

7 . A combination for use as claimed in claim 1, 4, 5 or 6 , an ophthalmic composition according to claim 2, 4, 5 or 6 or a kit according to claim 3, 4, 5 or 6 , wherein said sesamin is a purified compound.

8 . A combination for use, ophthalmic composition or kit as claimed in claim 7 , wherein said sesamin has purity higher than 70% w/w, more preferably higher than 80% w/w, higher than 90% w/w or higher than 95% w/w.

9 . An ophthalmic composition according to claim 2, 4, 5, 6, 7 or 8 , or a kit according to claim 3, 4, 5, 6, 7 or 8 , wherein said compositions comprise one or more excipients selected from trehalose, mannitol, cellulose ethers, buffering agents, polyethylene glycols, surfactants, emulsifying agents and antioxidant compounds.

10 . An ophthalmic composition as claimed in claim 2, 4, 5, 6, 7, 8 or 9 in form of a liquid ophthalmic formulation.

11 . A kit as claimed in claim 3, 4, 5, 6, 7, 8 or 9 , wherein at least one of said ophthalmic compositions a) and b) is in form of liquid ophthalmic formulation.

12 . An ophthalmic composition as claimed in claim 10 , wherein said liquid ophthalmic formulation comprises NGF at a concentration between 5 μg/ml and 300 μg/ml.

13 . A kit as claimed in claim 11 , wherein said ophthalmic composition a) is in form of liquid ophthalmic formulation and comprises NGF at a concentration between 5 μg/ml and 300 μg/ml.

14 . An ophthalmic composition as claimed in claim 10 or 12 , wherein said liquid ophthalmic formulation comprises sesamin at a concentration between 0.5 and 20 μg/ml.

15 . A kit as claimed in claim 11 or 13 , wherein said ophthalmic composition b) is in form of liquid ophthalmic formulation and comprises sesamin at a concentration between 0.5 and 20 μg/ml.

16 . An ophthalmic composition as claimed in claims 2, 4, 5, 6, 7, 8, or 9 in form of a powder formulation.

17 . A kit as claimed in claims 3, 4, 5, 6, 7, 8, 9, 11 or 15 , wherein said ophthalmic composition a) is in form of a powder formulation, and said ophthalmic composition b) is in form of a liquid ophthalmic formulation.

18 . An ophthalmic composition according to claims 2, 4, 5, 6, 7, 8, 9, 10, 12, 14, or 16 or a kit according to claims 3, 4, 5, 6, 7, 8, 9, 11, 13, 15 or 17 , for use by topical administration in the treatment of an ocular disorder known to be treatable by NGF.

19 . A combination for use according to claim 1 , an ophthalmic composition or kit for use as claimed in claim 18 , wherein said ocular disorder is selected from a corneal, conjunctival, scleral, retinal or optic nerve disorders.

20 . A combination, ophthalmic composition or kit for use as claimed in claim 19 , wherein said ocular disorder is selected from toxic and phototoxic keratopathy, iatrogenic, immune and neurotrophic corneal epithelial defects and ulcers, neurotrophic keratopathy, neuropathic corneal pain, keratoconjunctivitis sicca, Sjögren's syndrome-associated dry eye, retinitis pigmentosa, retinal detachment, retinal degeneration subsequent to ischemia, phototoxic retinopathy, epiretinal membrane, macular hole, macular degeneration, optic neuropathies, glaucoma, scleritis and episcleritis.

Assignees

• Dompe Farm Spa

Inventors

• Romeo Tiziana
• Detta Nicola
• Mantelli Flavio
• Tomassetti Mara
• Bianchini Gianluca
• Lillini Samuele
• Aramini Andrea
• Brandolini Laura
• Cocchiaro Pasquale

Classifications

• A61K47/38

  Cellulose; Derivatives thereof · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title

• A61K47/10

  Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers · CPC title

• A61K31/36

  Compounds containing methylenedioxyphenyl groups, e.g. sesamin · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title