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.

Abstract: A composition and process for suppressing pain and irritation of tissue includes an anti-irritant in an effective amount to suppress pain and irritation temporarily when applied topically to the skin or mucosa. The anti-irritant is a natural or non-nutritive sweetener. The composition can be a solid containing an edible acid such as citric acid and ascorbic acid from fresh lemon juice to form a solution having a pH of about 2.0 to 4.0 and an anti-irritant, such as sodium saccharine. The composition can be used to apply a pharmaceutical agent to the skin, mucosa or eye without irritation. The acidic composition can further be used to remove or loosen calculus deposits from the teeth without burning or irritation of the gums.

Abstract: The invention provides a method for delivering biologically active molecules to the eye by implanting biocompatible capsules containing a cellular source of the biologically active molecule. Also provided is a method of treating ophthalmic diseases using biocompatible capsules.

Abstract: An O/W emulsion composition comprising fluorometholone or clobetasone butyrate, a phospholipid, an oil, a nonionic water-soluble cellulose derivative, and water. The O/W composition has advantages that fluorometholone or clobetasone butyrate contained therein is highly bioavailable and that the solubility of fluorometholone or clobetasone butyrate and the concentration thereof present in the composition can be kept stable. Thus, this composition is usable for the treatment of various inflammatory diseases by the generalized or local administration thereof. It provides a drug which shows an anti-inflammatory activity equal or higher than that of commercially available eye drops comprising a suspension of such an active ingredient even when it is applied in a smaller dose than that of commercially available one and further provides a drug having excellent storability, which reduces apprehension of systemic side effects of fluorometholone or clobetasone butyrate when it is applied to the eyes.

Abstract: Liquid pharmaceutical compositions for administration to a mucosal surface, comprising a therapeutic agent and a pectin with a low degree of esterification are described. Such compositions gel, or can be adapted to gel, at the site of application in the absence of an extraneous source of divalent metal ions.

Abstract: Specific Cytokine Antagonists, including TNF antagonists and/or Interleukin-1 antagonists, are used as novel therapeutic agents for the treatment of hearing loss, including presbycusis and other forms of sensorineural hearing loss. The present invention provides a method for inhibiting the action of TNF and/or IL-1 antagonists for treating hearing loss in a human by administering a TNF antagonist and/or an IL-1 antagonist for reducing the inflammation affecting the auditory apparatus of said human, or for modulating the immune response affecting the auditory apparatus of said human, by administering a therapeutically effective dosage level to said human of a TNF antagonist and/or an IL-1 antagonist. Administration may be systemic, through the subcutaneous, intramuscular, oral, or intravenous routes; or by delivering an anatomically localized application in the region of the head.

Abstract: A nanoemulsion, the oil globules of which have a number-average size of less than 100 nm, comprising a surfactant chosen from mixed esters of a fatty acid or of a fatty alcohol, of a carboxylic acid and of glycerol and at least one oil having a molecular weight of greater than 400, the ratio by weight of the amount of oily phase to the amount of surfactant ranging from 2 to 10. The nanoemulsion may be used in, for example, the cosmetics and dermatological fields, in particular for moisturizing the skin and/or mucous membranes, as well as for treating the hair, and in the ophthalmological field, as an eye lotion for treating the eyes.

Abstract: A method for inhibiting the action of TNF for treating neurological conditions in a human by administering a TNF antagonist for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human, comprising the step of: administering a therapeutically effective dosage level to said human of said TNF antagonist selected from the group consisting of etanercept, infliximab, and D2E7 (a human anti-TNF mAb from Knoll Pharmaceuticals) for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human. In addition, for the viral-associated neurological disorders, the following additional step is performed: administering a therapeutically effective dosage level to said human of an antiviral agent or anti-retroviral agents for reducing the inflammation of neuronal tissue of said human, or for modulating the immune response affecting neuronal tissue of said human.

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; interleukin-1; interleukin-6; and interleukin-8.

Abstract: The present invention is directed to a drug delivery device for a human eye. The human eye has a sclera, an inferior oblique muscle, and a macula. The device of the present invention includes a pharmaceutically active agent, and a geometry that facilitates the implantation of the device on an outer surface of the sclera, beneath the inferior oblique muscle, and with the pharmaceutically active agent disposed above the macula. Methods of delivery a pharmaceutically active agent to the posterior segment of the human eye are also disclosed.

Abstract: A nanoemulsion, the oil globules of which have an average size of less than 100 nm, comprising an anionic surfactant chosen from alkyl ether citrates and at least one oil having a molecular weight of greater than 400, the ratio by weight of the amount of oily phase to the amount of surfactant ranging from 2 to 10. The emulsion obtained is transparent and stable on storage. It can comprise large amounts of oil while retaining good transparency and while having good cosmetic properties. It can constitute a composition for topical use, a pharmaceutical composition or an ophthalmological composition. The invention also relates to the use of the nanoemulsion according to the invention in the cosmetics and dermatological fields, in particular for moisturizing the skin and/or mucous membranes, as well as for treating the hair, and in the ophthalmological field, as an eye lotion for treating the eyes.

Abstract: Drug delivery devices, and methods of delivering pharmaceutically active agents to a target tissue within a body using such devices, are disclosed. One drug delivery device includes a body having an internal surface for placement proximate a target tissue and a well having an opening to the internal surface. An inner core comprising a pharmaceutically active agent is disposed in the well.

Abstract: An ophthalmic composition for prophylaxis and/or treatment of keratoconjunctivitis sicca, which is locally administered to the eyes and which comprises, as an effective component, at least one member selected from the group consisting of vitamin D, active vitamin D, and active vitamin D analogues.

Abstract: A device, methods and pharmaceutical compositions are disclosed for transnasal or transocular drug delivery to the central nervous system using a combination of electrotransport or phonophoresis with chemical permeation enhancers.

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: A composition for rendering a vitreous cavity visible during a surgical procedure to alleviate a structural disorder caused by the vitreous in an eye, and a method of using the composition. The composition is a vitreous delineating agent that is translucent, opaque or semi-opaque and is in a formulation that may be a solution, a suspension or an emulsion. The agent may be a liposome or microsphere that may additionally contain a therapeutic agent. In use, the agent marks or delineates the vitreous cavity, allowing a surgeon to clearly visualize the entire cavity. Use of the method improves accuracy of a vitrectomy and thus prevents suboptimal outcomes or the need for repeated procedures.

Abstract: A pharmaceutical formulation may be prepared by a method comprising providing the active ingredient in solution in a pharmacologically-acceptable base and mixing the resulting solution with a pharmacologically-acceptable acid in an amount such that the formulation attains a pH in the range of from about 3.5 to about 8.5 to thereby precipitate out the active ingredients, a viscosity-enhancing agent having been incorporated in the formulation prior to or during the mixing with acid. The formulation is suitable for administration of a pharmacologically active ingredient which is sparingly soluble in water at a pH acceptable for administration, for example to the eye of the patient.

Abstract: A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled manner. The device includes an inner core or reservoir including the effective agent, an impermeable tube which encloses portions of the reservoir, and a permeable member at an end of the tube.

Abstract: Topically administrable anti-allergy compositions comprising olopatadine and a polymeric quaternary ammonium preservative are suitable for use by patients wearing contact lenses.

Abstract: A controlled release medicament delivery system comprises a plasticized bioerodible polymer, such as a polyorthoester. Medicament desirably is entrapped in the plasticized polymer. The resulting delivery system is able to release the medicament in a controlled and sustained manner. The formulation is particularly advantageous for use as a once-a-day eyedrop. During preparation, the polymer may be heated to an elevated temperature for a sufficient time to substantially reduce its molecular weight.

Abstract: A contact lens having a pharmaceutical agent releasably disposed therein. The lens itself comprises a polymer of an unsaturated carboxylic acid ester of salicylic acid, the unsaturated carboxylic acid having up to 24 carbon atoms and 1-4 ethylenic double bonds, or a pharmaceutically acceptable salt of the salicylic acid ester.

Abstract: A biological material is prepared for use in ophthalmology by steps of providing animal pericardium, subjecting the animal pericardium to multiple steps of freezing and thawing in a salt solution and incubating the animal pericardium in a solution of ammonia and ethyl alcohol. The multiple steps of freezing and thawing are conducted in a mixture of about 0.9% sodium chloride solution and distilled water in about 1:1 proportions of sodium chloride solution to distilled water. The incubating step is conducted in a mixture of 1% ammonia solution and 1% ethyl alcohol solution in about 1:1 proportions of ammonia solution to ethyl alcohol solution over a period of 48 to 72 hours.

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 borate-polyol 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: Methods are provided for treatment of eye disorders and injury, including methods for treatment of reduced flow of blood or other nutrients to retinal tissue and/or optic nerve, methods for treatment of retinal ischemia and trauma and methods for treatment for optic nerve injury/damage.

Abstract: Delivery devices capable of delivering one or more active substances by diffusion through plural micropores in the membrane or by osmotic pumping through one or more preformed passageways in the membrane are provided. The device has an about centrally located expandable core completely surrounded by an active substance-containing layer, which is completely surrounded by the membrane. The device is capable of delivering insoluble, slightly soluble, sparingly soluble and very soluble active substances to an environment of use. The preferred delivery rate is zero order. The device can deliver an active substance for a period of about 12-24 hours.

Abstract: The present invention is directed to a method of treating dry eye by instilling eyedrops of a composition containing a cationic cellulosic polymer. Such compositions have been found to alleviate the symptoms of dry eye without requiring the presence of anionic therapeutic agents. Low ionic strength solutions are particularly preferred.

Abstract: A nanoemulsion comprising an oily phase dispersed in an aqueous phase and having oil globules with a number-average size of less than 100 mm, which dispersion is facilitated by a surfactant comprised of polyethylene oxide and polypropylene oxide blocks, the oily phase comprising at least one oil having a molecular weight of greater than 400 and wherein the ratio by weight of the amount of oily phase to the amount of surfactant ranges from 2 to 10.

Abstract: There is provided an aqueous liquid pharmaceutical composition which comprises Gatifloxacin (chemical nomenclature: (±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline carboxylic acid) or its salt and disodium edetate. Further, there are provided a method for raising corneal permeability of Gatifloxacin, a method for preventing precipitation of Gatifloxacin crystals, and a method for preventing coloration of Gatifloxacin by incorporating disodium edetate into an aqueous liquid preparation containing Gatifloxacin or its salt.

Abstract: Controlled release devices are disclosed which are biocompatible and can be implanted into the eye. The devices have a core comprising a drug and a polymeric outer layer which is substantially impermeable to the entrance of an environmental fluid and substantially impermeable to the release of the drug during a delivery period, and drug release is effected through an orifice in the outer layer. These devices have an orifice area of less than 10% of the total surface area of the device and can be used to deliver a variety of drugs with varying degrees of solubility and or molecular weight. Methods are also provided for using these drug delivery devices.

Abstract: A novel polyurethane based prepolymer useful in biomedical devices which provides high oxygen permeability and superior physical properties.

Abstract: A method and device for delivering a biologically active molecule to the eye, either intraocularly or periocularly, and method and device for treating ophthalmic disorders in a patient suffering therefrom.

Abstract: A topical ophthalmic composition for the treatment of dry eye in humans, comprising one or more histamine H2 agonists, is disclosed.

Abstract: This invention provides improved devices and methods for long-term, stable expression of a biologically active molecule using a biocompatible capsule containing genetically engineered cells for the effective delivery of biologically active molecules to effect or enhance a biological function within a mammalian host. The novel capsules of this invention are biocompatible and are easily retrievable. This invention specifically provides improved methods and compositions which utilize cells transfected with recombinant DNA molecules comprising DNA sequences coding for biologically active molecules operatively linked to promoters that are not subject to down regulation in vivo upon implantation into a mammalian host. Furthermore, the methods of this invention allow for the long-term, stable and efficacious delivery of biologically active molecules from living cells to specific sites within a given mammal.

Abstract: The present invention relates to ophthalmic compositions for the treatment of ocular hypertension and glaucoma, comprising a hypotonic solution of 0.1 to 0.2% (w/w) of xanthan gum and 0.5 to 5% (w/w) of a topical carbonic anhydrase inhibitor or an ophthalmologically acceptable salt thereof.

Abstract: A flexible ocular insert device adapted for the controlled sustained release of a drug upon insertion into the upper or lower fornix of the eye. The device comprises an elongate body of a polymeric material including two end portions, wherein the body contains a pharmaceutically active ingredient, and wherein the device has a length of at least 8 mm and a maximum diameter not exceeding 1.9 mm. The device is sufficiently flexible to allow it to bend along the curvature of the eye within the upper or lower fornix upon its being positioned so that the longitudinal axis of the device is generally parallel to the transverse diameter of the eyeball, and the device does not extend onto any visible portion of the eyeball. Each of the end portions of the device is tapered towards the extremities of the device.

Abstract: A pharmaceutical product which includes two-chambers, one having a buffered diluent and the other having acetylcholine. Upon mixing the chamber contents, a buffered efficacious acetylcholine product is prepared for post-surgical ophthlamic injection. Another embodiment of the invention is a method of providing an acetylcholine product which has a substantially consistent final pH without substantial degradation of the acetylcholine. The method involves storing an unbuffered acetylcholine separate from a diluent solution which has been buffered, and mixing prior to use.

Abstract: A method for preventing or treating pathological changes which occur in association with cataract formation in the mammalian eye by protecting lens cells against the cataractogenic effects of transforming growth factor-&bgr; (TGF&bgr;). Estrogen or an estrogenic substance can be administered to the mammal or directly to or near the eye of the mammal. The means of administration can be by a pharmaceutical composition comprising estrogen, a membranous ocular patch impregnated with estrogen or a lens or lens implant coated or impregnated with estrogen.

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: Methods are provided for treatment of eye disorders and injury, including methods for treatment of reduced flow of blood or other nutrients to retinal tissue and/or optic nerve, methods for treatment of retinal ischemia and trauma and methods for treatment for optic nerve injury/damage.

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: The present invention provides a bilayer structure for encapsulating multiple containment units. These containment units can attach or contain therapeutic or diagnostic 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 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: The present invention provides an improved conjunctival insert for topical delivery of medication or lubrication into the conjunctival spaces and upon the ocular surface of human eye. Specifically, three physical designs are provided, differing by size, named “Large”, “Medium” and “Small”. Also provided are methods of treating ocular maladies and of lubricating or moisturizing a dry eye using the disclosed conjunctival inserts. Such inserts can also be used for veterinary practices in the cases of primates and quadrupeds.

Abstract: A method of treating a disease of condition administering topically to the skin or exposed tissue of a human, a dosage amount of a pharmaceutical composition, said dosage comprising a therapeutically effective amount of a drug to treat said disease or condition and a form of hyaluronic acid characterized in that the composition is immediately available to transport the drug percutaneously into the epidermis of the skin or exposed tissue to the site of trauma or pathology of the disease or condition to be treated.

Abstract: The present invention provides novel compositions and methods for using the S(+) enantiomer of desmethylselegiline (N-methyl-N-(prop-2-ynyl)-2-aminophenylpropane), for the treatment of selegiline-responsive diseases and conditions. Diseases and conditions responsive to selegiline include those produced by neuronal degeneration or neuronal trauma and those due to immune system dysfunction. Effective dosages are a daily dose of at least about 0.015 mg/kg of body weight.

Abstract: The present invention relates to a composition for the delivery of a pharmaceutical agent to a patient that comprises polyethylene glycol, an aqueous solution containing polyvinylpyrrolidone, and a pharmaceutical agent. The invention also relates to methods of making a composition for the delivery of a pharmaceutical agent.

Abstract: A method of treating a mammalian patient suffering from or prone to a condition characterized by late phase allergic reactions, airway hyperresponsiveness or inflammatory reactions, e.g., asthma, allergic rhinitis, allergic dermatitis, allergic conjunctivitis, inflammatory bowel disease or rheumatoid arthritis, comprising the administration to the patient of an oral, parenteral, intrabronchial, topical, intranasal or intraocular pharmaceutical composition containing in each dose about 0.005 to about 1.0 mg per kilogram of patient body weight of ultra-low molecular weight heparins (ULMWH) or other sulfated polysaccharides having average molecular weights of about 1,000-3,000 daltons. Suitable inhalant and other pharmaceutical compositions for use in the novel treatment method are also disclosed.

Abstract: An ophthalmic composition for prophylaxis and/or treatment of keratoconjunctivitis sicca, which is locally administered to the eyes and which comprises, as an effective component, at least one member selected from the group consisting of vitamin D, active vitamin D, and active vitamin D analogues.

Abstract: In vivo polymerizable intraocular lens compositions which comprise substituted fluoroalkyl or perfluoroalkyl monomers having anionic, cationic, and/or nonionic surface active functionality in the unsaturated fluorophobic ends. The compositions are preferably cured by UV photoinitiation and are useful in repairing torn or detached retinal tissue or forming intraocular lenses in situ.

Abstract: A biological material is prepared for use in ophthalmology by steps of providing animal pericardium, subjecting the animal pericardium to multiple steps of freezing and thawing in a salt solution and incubating the animal pericardium in a solution of ammonia and ethyl alcohol. The multiple steps of freezing and thawing are conducted in a mixture of about 0.9% sodium chloride solution and distilled water in about 1:1 proportions of sodium chloride solution to distilled water. The incubating step is conducted in a mixture of 1% ammonia solution and 1% ethyl alcohol solution in about 1:1 proportions of ammonia solution to ethyl alcohol solution over a period of 48 to 72 hours.