Abstract: Compositions, methods and devices are provided for treating and/or preventing uveitis.

Abstract: The components of this invention are chosen because of their complementarity for the prevention or treatment of diseases caused by the herpes simplex virus. L-Lysine favorably increases the physiologic immunomodulation necessary for defense against this virus. Zinc improves and maintains a normal immune response. 2-Deoxy-2-D-glucose and heparin sodium alter the surface interaction between the herpes virus and the cell, preventing fusion and infectivity. N-Acetyl-L-cysteine increases glutathione levels thereby creating a thiol redox barrier to the virus at the cell membrane. Quercetin reduces intracellular replication of the herpes virus and viral infectivity. Ascorbate, in concert with copper and D-&agr;-tocopherol, provides an antioxidant defense against the herpes virus, which tends to lose latency during period of oxidative, free radical excess. Selenium and quercetin also participate in reducing various oxidative stresses.

Abstract: Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.

Abstract: The invention is directed to a composite material, especially a biomedical device, e.g. an ophthalmic device, preferably a contact lens, with one or more wettable surfaces capable of holding a continous layer of aqueous fluid thereon which composite material comprises a bulk material and a hydrophilic coating characterized in that the hydrophilic coating consists of a carbohydrate attached covalently to reactive groups at the surface of the bulk material, either directly or via functional groups of an oligofunctional compound, said oligofunctional compound in turn having functional groups being capable of reacting with said reactive groups at the surface of the bulk material and with the carbohydrate, wherein said reactive groups are either inherently (a priori) present in the bulk material or wherein said reactive groups have been attached to the surface of the bulk material by a plasma surface preparation, as well as to a process of manufacture of such a composite material.

Abstract: The invention relates to a formulation comprising honey, at least one essential oil and/or at least on essential oil derivative. It also relates to the different uses of said formulation in the pharmaceutical, cosmetic and food industries.

Abstract: Ocular implant devices for the delivery of a therapeutic agent to an eye in a controlled and sustained manner. Dual mode and single mode drug delivery devices are illustrated and described. Implants suitable for subconjunctival placement are described. Implants suitable for intravitreal placement also are described. The invention also includes fabrication and implementation techniques associated with the unique ocular implant devices that are presented herein.

Abstract: The invention is directed to self-assembling, polymer-based delivery systems for proteins. The delivery systems comprises an active agent and a polyol ester of the invention, having a linear polyol containing six or more hydroxyl groups as a central backbone and biodegradable hydroxy carboxylic ester groups attached to the central backbone.

Abstract: A composition capable of forming a micelle in body fluids or in an aqueous medium and that can be injected into the body undiluted or as a diluted solution in an aqueous medium and method of preparation are disclosed. The composition comprises an amphiphilic block copolymer having a hydrophilic poly(alkyleneglycol) component and hydrophobic biodegradable polymer component, suspended in a poly (alkyleneglycol) medium. Such composition is used in the solubilization and administration of a poorly water-soluble drug.

Abstract: The present invention relates to compositions comprising polysiloxanes suitable for the preparation of accommodating intraocular lenses, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula. The present invention includes intraocular lenses made from said polysiloxane compositions having a Young's modulus less than about 10 kPa.

Abstract: Provided is a sustained release composition for sustained release of a pharmaceutical substance. The composition includes a biocompatible polymer that is highly amorphous and a pharmaceutical substance in a hydrophobic ion complex with an amphiphilic material. Also provided is a compressed antisolvent method for manufacturing the composition, various product forms incorporating the composition and various uses for the composition.

Abstract: The invention relates to a sterile ophthalmic drop preparation, especially a gel preparation, which comprises a two-phase carrier liquid or gel basis comprising a liquid aqueous and a liquid hydrophobic phase.

Abstract: The invention relates to stable ophthalmic preparations including the penetrant antiphlogistic diclofenac or salts thereof and the penetrant antibiotic ofloxacin present in the form of the racemate, an enantiomer, particularly levofloxacin, or the corresponding hydrochloride thereof. The preparations may be used for treating eye infections and/or inflammations and for preventing infections before and after eye surgery.

Abstract: Azalide antibiotics such as azithromycin are useful in the treatment and prevention of infections by bacteria and other parasites. Stabilized aqueous compositions containing azithromycin suitable for administration without reconstitution are provided for. Also provided for are aqueous formulations suitable for ocular administration in a employing a convenient dosing formulation suitable for administration in depot formats.

Abstract: A polyurethane based prepolymer is provided and useful in biomedical devices which provides high oxygen permeability and superior physical properties. A hydrogel is produced from a comonomer mixture containing a polysiloxane-containing urethane prepolymer, tris(trimethylsiloxy)-silylpropyl methacrylate and a hydrophilic comonomer. The hydrogel is especially useful for biomedical materials such as contact lenses and implants.

Abstract: A process for producing a small-sized, lipid-based cochleate. Cochleates are derived from liposomes which are suspended in an aqueous two-phase polymer solution, enabling the differential partitioning of polar molecule based-structures by phase separation. The liposome-containing two-phase polymer solution, treated with positively charged molecules such as Ca2+ or Zn2+, forms a cochleate precipitate of a particle size less than one micron. The process may be used to produce cochleates containing biologically relevant molecules.

Abstract: A method for producing an intraocular lens, comprising the steps of injecting a high-refractive index, low viscosity composition of crosslinkable units into an enclosure and initiating polymerization under pressure to create a synthetic polymer lens. The method is especially suitable for producing an intraocular lens directly in the capsular bag of the eye from an injected aqueous solution of macromolecular particles, which can undergo a crosslinking reaction to a solid lens when exposed to light.

Abstract: An ophthalmic composition particularly in the form of eye-drops suitable for the treatment of diseases of the eye and surrounding areas. The composition contains a cyclosporin and a surfactant selected from polyoxyethylene fatty acid esters, polyoxyethylene alkylphenyl ethers and polyoxyethylene alkyl ethers, or mixtures thereof.

Abstract: The present invention provides a gastric and/or duodenal adhesive pharmaceutical composition obtained by coating a composition, which comprises a medicament acting at the stomach and/or duodenum and one or more of ingredients selected from water insoluble polymers, polyglycerin fatty acid esters, lipids and waxes, with a polymer having adhesive capacity onto the surface of the mucosa of a digestive tract under acid conditions and separates from the mucosa of the digestive tract in neutral or alkaline conditions. This composition adheres only to the mucosa of the stomach and/or duodenum and releases the medicament over long hours so that sufficient effects are available by a small amount of the medicament.

Abstract: An ocular iontophoretic device for delivering an aptamer to an affected area of a living being's eye for inhibiting VEGF function therein, the device comprising an active electrode assembly associated with a matrix and/or reservoir, wherein the matrix and/or reservoir includes an aptamer capable of inhibiting VEGF function. A method for treating an affected area of a living being's eye, comprising the steps of: associating an aptamer with an ocular iontophoretic device; positioning at least a portion of an ocular iontophoretic device on the eye of the living being; and iontophoretically delivering the aptamer to an affected area of the living being's eye.

Abstract: The topical application of an azalide antibiotic such as azithromycin to the eye is useful in treating or preventing ocular infections. In one embodiment, the azalide antibiotic is supplied to the eye in a depot for sustained release. A more convenient dosing regimen can also be provided by the use of an appropriate depot. Furthermore, a composition containing a combination of medicaments is also provided.

Abstract: The present invention provides solid pharmaceutical compositions for improved delivery of a wide variety of pharmaceutical active ingredients contained therein or separately administered. In one embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier including a substrate and an encapsulation coat on the substrate. The encapsulation coat can include different combinations of pharmaceutical active ingredients, hydrophilic surfactant, lipophilic surfactants and triglycerides. In another embodiment, the solid pharmaceutical composition includes a solid carrier, the solid carrier being formed of different combinations of pharmaceutical active ingredients, hydrophilic surfactants, lipophilic surfactants and triglycerides. The compositions of the present invention can be used for improved delivery of hydrophilic or hydrophobic pharmaceutical active ingredients, such as drugs, nutrionals, cosmeceuticals and diagnostic agents.

Abstract: The present invention encompasses a solid dose delivery vehicle for ballistic administration of a bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis. The delivery vehicle further comprises a stabilizing polyol glass loaded with the bioactive material and capable of releasing the bioactive material in situ. The present invention further includes methods of making and using the solid dose of the invention.

Abstract: The present invention provides compositions and methods of preparing a bilayer structure for encapsulating multiple containment units. These containment units can contain therapeutic, diagnostic agents or imaging agents that can be released through the bilayer structure. A suitable example of such a containment unit is a unilamellar or multilamellar vesicle.

Abstract: The invention relates to an ocular tissue regeneration inducer which comprises, as an active ingredient, a hydrophilic polymer mainly composed of alkylene glycol units or vinyl monomeric units having a nondissociating hydrophilic group. The composition can induce the regeneration of ocular tissues such as the cornea, the crystalline lens, and the vitreous body.

Abstract: The present invention involves the discovery that synthetic thyroid hormones can be used as compositions to reduce intraocular pressure in vivo. Methods of screening synthetic thyroid hormones for effect on intraocular pressure, aqueous pressure, hydraulic conductivity, hyaluronic acid secretion, and extracellular matrix assembly are provided. Methods of treating glaucoma and treating excess intraocular pressure with synthetic thyroid hormones and compositions therefore are also provided.

Abstract: The present invention relates to a method for administering a corticosteroid to a posterior segment of an eye. In the method, a sustained release device is implanted to deliver the corticosteroid to the eye. The aqueous corticosteroid concentration remains less than vitreous corticosteroid concentration during release of the corticosteroid from the device.

Abstract: A method of reducing intra-ocular pressure (IOP) in a patient afflicted with elevated IOP is disclosed. The method comprises the step of administering (preferably topically to an afflicted eye) to the patient a therapeutically effective amount of a &bgr;-HSD-1 inhibitor.

Abstract: A high current density iontophoretic device, comprising a reservoir, an applicator, an orientation maintaining member and an iontophoretic medicament administering member. The reservoir is capable of retaining medicament. The applicator is positionable upon a surface of an eye and includes at least one punctation therethrough. The at least one punctation is capable of being placed in fluid communication with each of the reservoir and at least one treatment area of an eye upon operative positioning of same. The orientation member substantially maintains the orientation of the applicator in the desired orientation upon operative positioning of same. The iontophoretic administering member serves to administer a medicament from the reservoir to the at least one punctation and, in turn, to a specific region of an eye of a patient.

Abstract: The present invention provides methods for promoting healing of wounds which result from corneal resurfacing procedures, e.g. from laser surgery to alter refractive of the eye. The methods involve the application of a sheet of cultured epithelial cells to the laser corneal resurfacing wound of a subject in need of such treatment. The methods promote faster healing of corneal resurfacing wounds relative to prior art methods of healing such wounds. The invention also provides corneal wound healing devices having the shape and dimensions of a contact lens.

Abstract: A defective recombinant adenovirus including at least one DNA sequence coding for all or an active part of a superoxide dismutase or a derivative thereof. The therapeutical use thereof and corresponding pharmaceutical compositions are also disclosed.

Abstract: Cytokine antagonists for use in localized clinical disorders are provided for the treatment and prevention of damage to the optic nerve, other cranial nerves, spinal cord, nerve roots, peripheral nerves or muscles caused by any one of the following: a herniated nucleus pulposus, osteoarthritis, other forms of arthritis, disorders of bone, disease, or trauma. The cytokine antagonists are used to treat these disorders by local administration. These cytokine antagonists include antagonists to tumor necrosis factor.

Abstract: An Enzyme Orthokeratology method is provided for correcting refractive errors in the eye of a subject mammal. Accelerating reshaping of the cornea is accomplished by administering a corneal hardening amount of a corneal hardening agent to the eye of the subject. Reformation is accomplished under the influence of a rigid contact lens or a series of lenses having a concave curvature that will correct a refractive error. The cornea rapidly reshapes its convex curvature to the concave curvature of the contact lens, rendering the eye emmetropic. The cornea is permitted to “harden” to retain the new emmetropic shape. After “hardening” has occurred, the lens rendering the eye emmetropic is removed.

Abstract: The present invention relates, in general, to methods of treating disorders of the eye, and, in particular, to methods of preventing or treating elevated eye pressure and glaucoma. The invention further relates to compounds and compositions suitable for use in such methods.

Abstract: This invention provides a method for treating a subject with glaucoma by administrating a composition containing an agent or molecule which antagonize, inhibits, inactivates, reduce, suppresses, antagonizes, and/or limits the release, synthesis, or production from cells of TNF-&agr; thereby treating the subject with glaucoma.

Abstract: A formulation for the treatment of a parasitic skin disease includes a parasiticide to kill the parasite. The formulation also includes a polymer effective to increase retention of the formulation on the skin, and to reduce absorption of the formulation into the skin. Alternatively, the formulation may include a polymer such as a beta-sheet breaker peptide which is effective to increase absorption of the insecticide into the head lice and/or the eggs of the head lice. The formulation also includes a vehicle for the polymer and the parasiticide.

Abstract: The present invention includes a method for producing an implantable polymer/drug matrix mass, comprising the steps of (1) forming a polymer solution/drug mixture comprising a polymer dissolved in an organic solvent and a suspended labile drug; (2) removing the solvent from the polymer solution/drug mixture, thereby forming a solid polymer/drug matrix; and (3) mechanically compressing the polymer/drug matrix, thereby forming an implantable polymer/drug matrix mass.

Abstract: Dosage forms prepared by solid free form fabrication (SFF) provide release of medicament in multiple phases.

Abstract: The present invention relates to a method for administering a corticosteroid to a posterior segment of an eye. In the method, a sustained release device is implanted to deliver the corticosteroid to the eye. The aqueous corticosteroid concentration remains less than vitreous corticosteroid concentration during release of the corticosteroid from the device.

Abstract: Biomedical devices with antimicrobial coatings are provided. One or more surfaces of the device are coated with a cationic peptide, cationic proteins, or mixtures thereof to impart antimicrobial properties to the surface.

Abstract: Water-soluble borate-polyol complexes are useful as buffers and/or antimicrobials in aqueous ophthalmic compositions, including those containing polyvinyl alcohol. These compositions have greater antimicrobial activity than comparable compositions containing typical borate buffers and unexpectedly increase the antimicrobial efficacy of other antimicrobial agents when used in combination. In addition, use of the boratepolyol complexes avoids the incompatibility problem typically associated with the combination of borate buffer and polyvinyl alcohol; therefore, the compositions disclosed herein may also contain polyvinyl alcohol.

Abstract: This invention provides vehicles capable of delivering high concentrations of poorly hydrophilic/poorly lipophilic compounds to animals, by combining compounds having biocompatible hydrophobic domains with conjugates having both hydrophobic and hydrophilic regions. Such formulations are suitable for a number of uses in animals, particularly the administration thereto of high concentrations of therapeutically useful compound, without an undue level of side effects.

Abstract: The present invention relates to a delivery system for topical application to the skin comprising a freeze-dried, partially cross-linked polymeric gel membrane which can be reversibly returned to a dissolvable gel form upon the application of a wetting agent. The membrane can be used to deliver biologically active agents to the skin.

Abstract: Isoflavone compositions derived from soy molasses are provided. In a first embodiment, an isoflavone material derived from soy molasses containing at least two isoflavones is provided, where at least one of the isoflavones is genistein. In a second embodiment, an isoflavone material derived from soy molasses containing at least two isoflavones is provided, where at least one of the isoflavones is daidzein.

Abstract: A scleral plug which releases a drug accurately in a specified amount. The scleral plug is formed from a blend of a high-molecular weight polylactic acid having a molecular weight of 40,000 or higher and a low-molecular weight polylactic acid having a molecular weight of 40,000 or lower, and contains a drug for treating or preventing a vitreoretinal disease. The high-molecular weight polylactic acid and the low-molecular weight polylactic acid are in a blending ratio of preferably 90/10 to 50/50, more preferably 90/10 to 70/30, and most preferably 80/20. The molecular weight of the high-molecular weight polylactic acid is preferably 40,000 to 200,000. The molecular weight of the low-molecular weight polylactic acid is preferably 3,000 to 40,000, and more preferably 5,000 to 20,000. The drug is, for example, an antiulcer agent, an antiviral agent, an anti-inflammatory agent, an antifungal agent or an antimicrobial.

Abstract: A weighted upper eyelid implants for assisting and achieving complete eyelid closure and partial recreation of a natural blinking reflex. The implant is formed of a main plate having suture channels extending partially therethrough for receiving a suture knot tied in a suture passing through an adjacent suture hole thereby securing the weighted implant to the eyelid while preserving a cosmetically pleasing image.

Abstract: Described are compositions, methods, and articles of manufacture for the closure of retinal breaks with a non-toxic polymer. Transformation to a gel-like coat is achieved by photochemical reactivity, chemical reactivity, and by physicochemical response.

Abstract: The present invention describes an autoclavable ophthalmic composition comprising an ophthalmically effective drug. The invention further relates to a method for stabilizing an ophthalmic drug.

Abstract: Nonaqueous pharmaceutical compositions for use in aqueous physiological systems are disclosed comprising drug delivery suspension of nonaqueous perfluorocarbon or fluorinated silicone liquid carriers. The suspended drug may be water labile or water stable and therapeutic or diagnostic compounds which will remain stable and pharmaceutically effective for extended periods. The pharmaceutical compositions have improved bioavailability, are capable of low dose volume delivery, and do not degrade the incorporated therapeutic or diagnostic compounds making them well suited for multi-dose packaging and administration.

Abstract: The components of this invention are chosen because of their complementarity for the prevention or treatment of diseases caused by the herpes simplex virus. L-Lysine favorably increases the physiologic immunomodulation necessary for defense against this virus. Zinc improves and maintains a normal immune response. 2-Deoxy-2-D-glucose and heparin sodium alter the surface interaction between the herpes virus and the cell, preventing fusion and infectivity. N-Acetyl-L-cysteine increases glutathione levels thereby creating a thiol redox barrier to the virus at the cell membrane. Quercetin reduces intracellular replication of the herpes virus and viral infectivity. Ascorbate, in concert with copper and D-&agr;-tocopherol, provides an antioxidant defense against the herpes virus, which tends to lose latency during period of oxidative, free radical excess. Selenium and quercetin also participate in reducing various oxidative stresses.

Abstract: A pharmaceutical implant for administering a biologically active substance is made up of an immediate-release component, preferably containing a disintegrating agent, and a sustained-release component. The implant of the present invention provides flexibility in adjusting the release of the medicament and a faster onset of release can be provided along with a long-term sustained-release. The release rate of the biologically active substance can be adjusted by controlling the relative quantities of the immediate-release component and the sustained-release component.