Abstract: The present invention relates to ophthalmic compositions comprising from 0.005% to 0.02% bimatoprost by weight, less than 100 ppm benzalkonium chloride, and one or more secondary penetration enhancers that detectably enhance(s) penetration of bimatoprost into a mammalian eye such that elevated intraocular pressure is effectively reduced to an extent statistically comparable to compositions comprising higher amounts of bimatoprost and benzalkonium chloride. Further, the invention also provides a process of preparing such compositions and methods of their use for lowering intraocular pressure and treating glaucoma.

Abstract: The present invention relates to the role of purinergic receptors and ATP in T cell activation and autocrine system signaling. In one embodiment, the present invention provides a method of preventing or treating diabetes by administering a therapeutically effective inhibitor of ATP to a subject. In another embodiment, the present invention provides a method of preventing or treating fibrosis by administering a P2X7R soluble fusion protein. In another embodiment, the present invention provides a method of preventing or treating graft rejection by administering an inhibitor of P2X receptor signaling.

Abstract: Compositions and methods to reduce the risk of graft versus host disease (GVHD) in a subject receiving hematopoietic stem cell transplantation (HSCT). Also disclosed are methods for identifying patients receiving HSCT who are at risk for developing GVHD, methods for prognosing the severity of GVHD in a subject receiving HSCT, and methods for monitoring efficacy of a therapeutic for treatment of GVHD in a subject HSCT.

Abstract: A composition for preventing hair loss and, more specifically, to a compound having a structure in which finasteride and a peptide are linked through a covalent bond and a pharmaceutical composition or a cosmetic composition for preventing hair loss or promoting hair growth comprising the same. The compound having a structure in which finasteride and a peptide are linked through a covalent bond is excellent in physiological activities such as hair loss improvement, hair growth promotion, cell growth promotion, etc., is excellent in stability in water and skin permeation, and thus can be effectively used as a composition for preventing hair loss and promoting hair growth.

Abstract: Compositions that are aqueous suspensions of cyclosporin and contain a cyclosporin (e.g., cyclosporin A), a pharmaceutically acceptable water soluble solvent for the cyclosporin, a dispersing agent, a suspending agent and an aqueous vehicle are disclosed. Methods of producing such compositions, as well as methods of using the compositions to treat ophthalmic disorders are also disclosed.

Abstract: Compositions and methods of using nintedanib for treating indications with abnormal neovascularization in the front part of the eye are disclosed.

Abstract: The present invention relates to a preservative-free ophthalmic composition for the reduction of elevated intraocular pressure containing Latanoprost or a combination of Latanoprost and Timolol and to a process for preparing such compositions.

Abstract: Compositions that are aqueous suspensions of cyclosporin and contain a cyclosporin (e.g., cyclosporin A), a pharmaceutically acceptable water soluble solvent for the cyclosporin, a dispersing agent, a suspending agent and an aqueous vehicle are disclosed. Methods of producing such compositions, as well as methods of using the compositions to treat ophthalmic disorders are also disclosed.

Abstract: Antimicrobial cationic polymers having one or two cationic polycarbonate chains were prepared by organocatalyzed ring opening polymerization. One antimicrobial cationic polymer has a polymer chain consisting essentially of cationic carbonate repeat units linked to one or two end groups. The end groups can comprise a covalently bound form of biologically active compound such as cholesterol. Other antimicrobial cationic polymers have a random copolycarbonate chain comprising a minor mole fraction of hydrophobic repeat units bearing a covalently bound form of a vitamin E and/or vitamin D2. The cationic polymers exhibit high activity and selectivity against Gram-negative and Gram-positive microbes and fungi.

Abstract: The present disclosure relates to suspension formulations and systems for the treatment of ocular conditions. The suspension formulations can include cyclosporin A and in some embodiments, Form 1 or Form 2 cyclosporin A. A delivery system can be provided that includes two parts, a first part containing particles of cyclosporin and a second part containing other components that can be combined with the first part to make a suspension formulation. The suspension can be injected into the subconjunctival or other periocular space to treat ocular conditions, such as dry eye disease.

Abstract: Disclosed herein are methods and compositions useful for preventing or reducing corneal haze of opacification resulting from Limbal Stem Cell Deficiency (LSCD). The invention comprises a method of preventing or treating corneal opacification, comprising administering to a subject a sufficient amount of a proteasome modulator. The invention also comprises a method of preventing or treating corneal opacification, comprising administering to a subject a sufficient amount of a proteasome modulator. In addition, the invention comprises a method of administering to a subject suffering from corneal opacification with a sufficient amount of proteasome modulator, resulting in reduction of Keratin proteins in the cornea of the subject.

Abstract: The present invention provides aqueous ophthalmic compositions in the form of solution comprising hexanoic acid, 6-(nitrooxy)-, (1S,2E)-3-[(1R,2R,3S,5R)-2-[(2Z)-7-(ethylamino)-7-oxo-2-hepten-1-yl]-3,5-dihydroxycyclopentyl]-1-(2-phenylethyl)-2-propen-1-yl ester and macrogol 15 hydroxystearate as the only solubilizing agent, and a method for their preparation.

Abstract: A composition is disclosed herein comprising from about 0.001% to about 0.

Abstract: The invention is directed to isomeric mixtures of cyclosporine analogues that are structurally similar to cyclosporine A. The mixtures possess enhanced efficacy and reduced toxicity over the individual isomers and over naturally occurring and other presently known cyclosporines and cyclosporine derivatives. Embodiments of the present invention are directed toward cis and trans-isomers of cyclosporin A analogs referred to as ISATX247, and derivatives thereof. Mixtures of ISATX247 isomers exhibit a combination of enhanced potency and reduced toxicity over the naturally occurring and presently known cyclosporins. ISATX247 isomers and alkylated, arylated, and deuterated derivatives are synthesized by stereoselective pathways where the particular conditions of a reaction determine the degree of stereoselectivity.

Abstract: A composition comprising from about 0.001% to about 0.4% cyclosporin A, a surfactant, and an oil having a specific gravity from 0.8 to 0.95 is disclosed herein.

Abstract: The disclosure generally describes methods of preventing or treating ophthalmic diseases or conditions in a mammalian subject, such as diabetic retinopathy, cataracts, retinitis pigmentosa, glaucoma, macular degeneration, choroidal neovascularization, retinal degeneration, and oxygen-induced retinopathy. The methods comprise administering an effective amount of an aromatic-cationic peptide to subjects in need thereof.

Abstract: Disclosed herein are novel analogs of cyclosporin, pharmaceutical compositions containing them, and methods for their use in the treatment of dry eye and other conditions.

Abstract: Provided is a composition for alleviating nephrotoxicity caused by an immunosuppressive drug, including metformin, and a composition for preventing or treating an immune disease, including the same. Further, the composition provided can be useful in improving a treatment effect on diseases requiring immunosuppression by effectively alleviating a decline in renal function caused due to side effects of conventional immunosuppressive drugs, and can also be useful in preventing or treating organ transplant rejection, autoimmune diseases, inflammatory diseases and the like since various methods of co-administering a conventional immunosuppressive drug and metformin are suggested to reduce nephrotoxic side effects of conventional immunosuppressive drugs and maximize immunosuppressive or immunomodulatory effects.

Abstract: The present invention is directed to a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a ?-(arylsulfonyl)alkylnitrile compound, or a pharmaceutically acceptable salt thereof. The present invention is also directed to a method for treating inflammation, inflammatory-related disorders, or pain, by administering an ?-(arylsulfonyl)alkylnitrile compound or a pharmaceutically acceptable salt or solvate thereof to a subject in need thereof.

Abstract: The present disclosure an in vitro method of assaying the stimulation of a cytokine storm response comprising the steps of: a. co-culturing PBMCs and matched differentiated endothelial cells to provide a system representative of human responses in vivo, and b. exposing the co-cultured cell system to a test agent, c. analyzing the system for the presence of one or more cytokines released after exposing the co-culture system to said test agent, and d. optionally evaluating the response to the test agent in comparison to a response to one or more control agents.

Abstract: Analogs of cyclosporin-A are disclosed comprising modifications of the substituents as the positions of amino acids 1 and 3, according to the following Formula. The disclosed compounds include compounds having affinity for cyclophilin, including cyclophilin-A, and reduced immunosuppressivity in comparison with cyclosporin-A and analogs thereof modified solely at position 1.

Abstract: Personal care compositions containing an active selected from the group consisting of phlorogine, phlorgine BG, deoxyArbutin, sucrose dilaurate, bakuchiol, pyrenoine, millet, arlatone dioic acid, cinnamic acid, ferulic acid, achromaxyl, methyl nicotinamide, oil soluble licorice extract, folic acid, undecylenic acid, zinc undecylenate, L-tryptophan, thiamine HCl, hexylresorcinol, lipidami red vine, dragosine, methyl gentisate, inositol, symdiol 68, laminaine, their salts, their derivatives, their precursors, and/or combinations thereof. Methods for regulating the condition of mammalian keratinous tissue by topically applying the personal care compositions are also provided.

Abstract: Disclosed herein are therapeutic methods, compositions, and medicaments related to cyclosporine.

Abstract: Disclosed herein are novel analogs of cyclosporin, pharmaceutical compositions containing them, and methods for their use in the treatment of dry eye and other conditions.

Abstract: Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.

Abstract: The present invention is directed to compositions and methods for stimulating the growth of nails and cuticles in a mammal, including humans. The compositions may be administered topically to the nail bed, nail matrix and cuticle in an amount effective to increase nail growth and thicken, strengthen and smooth the nail. The composition is also effective in strengthening and growing nails, including fingernails and toenails.

Abstract: A composition for increasing the bioavailability of an active pharmaceutical ingredient (“API”) in humans and animals, comprising a first water soluble surfactant having a cloud point greater than about 37° C., a second water soluble surfactant having a cloud point greater than about 37° C., wherein a mixture of the first surfactant and the second surfactant comprises a cloud point less than about 37° C.

Abstract: Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.

Abstract: The present invention relates to a cyclosporine emulsion containing: i) a cyclosporine ii) a natural oil (long chain triglyceride) iii) a phosphatidylcholine, iv) glycerol, v) a pharmaceutically tolerable alkali salt of a free fatty acid, vi) a medium chain triglyceride-oil vii) optionally, hydrochloric acid or sodium hydroxide for pH adjustment viii) water.

Abstract: A modified release composition comprising cyclosporin A for oral administration. The composition may comprise a core and a modified release coating, wherein the core comprises a hydrogel-forming polymer matrix and cyclosporin A. The composition may be in the form of a minibead. The compositions provide a pharmacokinetic profile and dissolution profile which provides release of cyclosporin A in the lower GI tract whilst minimising systemic exposure. Also disclosed are uses of the composition in the treatment of conditions affecting the lower GI tract, particularly the colon.

Abstract: A method for identifying a kidney transplant recipient at an increased risk of developing interstitial fibrosis or tubular atrophy which comprises obtaining a post-transplant urine sample from the kidney transplant recipient; measuring the level of clusterin in the urine sample; comparing the level of clusterin in the patient sample to the level of clusterin in a control sample from the urine of a non-fibrotic kidney transplant recipient; diagnosing a kidney transplant recipient with a clusterin level that is significantly higher than the clusterin level in the control as being at an increased risk of developing interstitial fibrosis or tubular atrophy.

Abstract: Methods for identifying new therapeutic activities for known therapeutic agents, as well as systems for practicing the same, are provided. Aspects of the invention further include are methods and compositions for the treatment of an acute graft rejection (AR).

Abstract: The present invention relates to the use of the measure of anelloviral load for the determination of immunosuppression. More precisely, the present invention provides a method for characterizing the immunosuppressed or non-immunosuppressed status of a subject, comprising the steps of determining the anelloviral load from a biological sample of the said subject, and determining from the said comparison the immunosuppressed or non-immunosuppressed status. The determination of the immunosuppressed status of the subject can then be used to design or adapt a therapeutic treatment.

Abstract: A liposomal formulation for targeting immunotherapy, with synergistic effect in the case of encapsulating an immunosuppressive drug, such as Cyclosporine A, and the method of preparing the same. The reduced toxicity and significant reduction of Delayed-Type Hypersensitivity DTH) due to extremely reduced dosage, potential therapeutic value in control of chronic transplant rejection, allergies and certain autoimmune diseases, and increased efficacy are some of numerous and significant benefits of the present invention.

Abstract: The present invention relates to a formulation comprising a pharmaceutically active ingredient and a coating. The invention also relates to the use of the formulation in the treatment and prevention of disorders of the gastrointestinal tract. Also disclosed are methods for preparing the formulations.

Abstract: Methods, devices, compositions and kits are provided for analysis of the microbiome or individual components thereof in an individual. The methods find use in a determination of infection, in analysis of the microbiome structure, in determining the immunocompetence of an individual, and the like. In some embodiments of the invention, the individual is treated with a therapeutic regimen, e.g. drugs, diet, radiation therapy, and the like.

Abstract: Provided is an ophthalmic composition containing cyclosporine as an active ingredient and including polyethoxylated castor oil or polyethoxylated hydrogenated castor oil, and a method of preparing the same. Particularly, the ophthalmic composition is prepared as a nanoemulsion having a particle diameter of 100 nm or less simply by mixing and stirring an oil phase and an aqueous phase without using a high speed stirring or shearing machine, so that it is very physiochemically stable and storable for a long time. In addition, the ophthalmic composition causes no irritation to eyes.

Abstract: Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.

Abstract: The invention relates to the use of a JAK1 kinase-selective inhibitor that has minimal inhibitory activity towards Jak2 kinase for treating a disease, such as an inflammatory disease (e.g., moderate to severe Rheumatoid Arthritis) and/or bone loss, either alone or in combination with a DMARD (disease modifying anti-rheumatic drug), such as methotrexate. The invention also provides pharmaceutical composition, dosage formulation, administration route, and dosage schedule thereof.

Abstract: The present invention relates to a compound of formula (I): or pharmaceutically acceptable salt thereof, wherein the symbols are as defined in the specification; a pharmaceutical composition comprising the same; a method for treating or preventing a viral infection using the same.

Abstract: Methods and compositions are provided for treating an ocular disease in a subject in need thereof by increasing the bioavailability of a drug in the subjects eye. By one approach, the ocular disease is endophthalmitis. The methods and compositions provided herein include an efflux transporter inhibitor and a drug effective for treating the ocular disease. The efflux transporter inhibitor is effective to reduce the efflux of the drug through at least one of Pglycoprotein (Pgp), breast cancer resistant protein (BCRP), and multidrug resistant associated protein 19 (MRP19). In one aspect, cyclosporine A is the efflux transporter inhibitor.

Abstract: The ophthalmic drug delivery vehicles provide comfort and compliance; drug solubility, residence time and permeability; and reduce side effects. In addition, the delivery vehicle can be slightly modified to provide an artificial tear formulation.

Abstract: A method of parenterally administering a composition, the method including parenterally administering to a person a composition including at least one omega-3 fatty acid and at least one drug, wherein the at least one omega-3 fatty acid source and the at least one drug are administered simultaneously.

Abstract: NK cell licensing predisposes patients to chronic inflammatory disease. Methods and kits to diagnose and treat chronic inflammatory disease based on genetic haplotype and cytokine profile are described herein.

Abstract: A cured non-polymeric gel including a plurality of non-polymeric cross-links. The non-polymeric cross-links result from curing an oil or oil composition at selected curing conditions to achieve a desired amount of cross-linking to form the non-polymeric get. The desired amount of cross-linking is selected based on a desired rate of degradation of the gel after the gel is implanted. The oil or oil composition comprises one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alphalinolenic acid (ALA).

Abstract: Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.

Abstract: Methods and compositions containing a phorbol ester or a derivative of a phorbol ester are provided for the treatment of chronic and acute conditions. Such conditions may be caused by disease, be symptoms or sequelae of disease. Chronic and acute conditions may be due to viral infections such as HIV and AIDS, neoplastic diseases stroke, kidney disease, urinary incontinence, autoimmune disorders, Parkinson's disease, prostate hypertrophy, aging, or the treatment of such diseases. Additional compositions and methods are provided which employ a phorbol ester or derivative compound in combination with at least one additional agent to yield more effective treatment tools against acute and chronic conditions in mammalian subjects.

Abstract: A cationic graft-copolymer for a drug delivery system comprising a unit derived from a having a hydroxyl groups, namely, a cationic polysaccharide of the following formula (1) (C6H7O2(OH)3-a (OX)a)xH2O (1) and a unit derived from a polymerizable olefin compound of the following formula (2) (a, x, X, R4, R5, R6, and R7 are defined in claim 1-8); a process for preparing the same and a transfection reagent made therefrom.

Abstract: Disclosed herein are novel analogs of cyclosporin, pharmaceutical compositions containing them, and methods for their use in the treatment of dry eye and other conditions.

Abstract: The invention is directed to isomeric mixtures of cyclosporine analogues that are structurally similar to cyclosporine A. The mixtures possess enhanced efficacy and reduced toxicity over the individual isomers and over naturally occurring and other presently known cyclosporines and cyclosporine derivatives. Embodiments of the present invention are directed toward cis and trans-isomers of cyclosporin A analogs referred to as ISATX247, and derivatives thereof. Mixtures of ISATX247 isomers exhibit a combination of enhanced potency and reduced toxicity over the naturally occurring and presently known cyclosporins. ISATX247 isomers and alkylated, arylated, and deuterated derivatives are synthesized by stereoselective pathways where the particular conditions of a reaction determine the degree of stereoselectivity. The ratio of isomers in a mixture may range from about 10 to 90 percent by weight of the (E)-isomer to about 90 to 10 percent by weight of the (Z)-isomer, based on the total weight of the mixture.