Abstract: Evaluation methods that employ the near infrared spectrum have generally had a low specificity and in particular have encountered difficulty in the evaluation of trace components, and the accurate measurement of coating quantity by methods using the near infrared spectrum has been quite problematic. The quantity of coating applied to a coating target, such as granules or uncoated tablets, is measured based on the absorption or scattering of light in the 800 to 1100 nm wavelength region by an additive coated on the coating target. The use of polyethylene glycol or a long-chain hydrocarbyl-containing compound as the additive is preferred.

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: Embodiments of the invention include coated medical devices that can elute one or more bioactive agents within the body, and methods for producing the same. In an embodiment, the invention includes a method of forming a coated medical device including depositing a coated composition onto a medical device having a roughened segment and a smooth segment. In an embodiment, the invention includes a method of forming a coated implantable medical device including depositing a coated composition onto a medical device having a body segment and a piercing segment. In an embodiment, the invention includes a medical device, a coated composition provided on the substrate surface, the composition including a bioactive agent and a polymer. The medical device includes an uncoated component wherein the edge of the coated composition is within 0.5 mm of the uncoated component.

Abstract: Methods and systems are described for a rapid and sustainable change in the pigment melanin content of melanocytes of the iris stroma, thereby to change the color of the eye. Also described are compositions for lightening or darkening the pigmented tissues or treating a pigmented tissue disease.

Abstract: The present invention provides engineered proteins and biomedical products made from the engineered proteins. The biomedical products include lenses useful for ophthalmic purposes.

Abstract: Disclosed is a drug delivery system for delivering a drug at a sustained constant rate for a long period, which can be transplanted into an affected part safely and in a simple manner and can deliver a drug to the affected part for a long period. Specifically disclosed is a sustained drug delivery system in which an implant is implanted into a body, wherein the implant is a PEG capsule comprising a box-shaped PEG and a porous PEG sheet.

Abstract: Biocompatible intraocular implants include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. The implants may be placed in an eye to treat or reduce a at least one symptom of an ocular condition, such as glaucoma.

Abstract: A composition comprising a polymer that comprises oxidated hyaluronic acid cross-linked by a dihydrazide is disclosed. The polymer is a hydrogel exhibiting the following properties: a) transparent and colorless; and b) transforming from a liquid state into a gel-matrix at 37° C. These characteristics make it useful as a vitreous humor substitute.

Abstract: Tissue lacerations are closed using a vacuum cup applied to the tissue surface having a tissue-abutting, optically transparent mesh surface that under vacuum conforms with the tissue surface, apposing edges of the wound, and is optionally loaded with a bandage comprising a chitosan film and a collagen backing. An eye tissue surface wound is closed without sutures by closing the wound with a bioadhesive, biocompatible sclera or cornea wound patch comprising a chitosan film and a collagen backing, wherein the backing is bonded to the film without adhesive and protects the film against dissociation when the patch is exposed to a physiological fluid, and the film adheres to the sclera sufficient to retain apposed edges of the wound.

Abstract: This invention describes the use of polymerizable surfactants as comonomers in forming ophthalmic devices such as contact lenses, intraocular lenses, corneal implants, etc.

Abstract: The present invention relates to reversible hydrogel systems for medical applications. Particularly, the hydrogel of the present invention is made up of copolymers that can be a hydrogel when in an oxidized state and can be a solution when in a reduced state. A solution of the copolymer can be oxidized to form a hydrogel; and the hydrogel can be reduced to form a solution of the copolymer. The solution can be dehydrated to produce the dry copolymer for storage. Furthermore, the present invention also relates to methods of making and using the reversible hydrogel systems.

Abstract: Compositions including a surface or film comprising nanofibers, nanotubes or microwells comprising a bioactive agent for elution to the surrounding tissue upon placement of the composition in a subject are disclosed The compositions are useful in medical implants and methods of treating a patient in need of an implant, including orthopedic implants, dental implants, cardiovascular implants, neurological implants, neurovascular implants, gastrointestinal implants, muscular implants, and ocular implants.

Abstract: An apparatus and a method for removing epithelium from the cornea include a fluid agent for facilitating de-epithelialization of the cornea. A disc includes a biocompatible material operable for covering a predetermined zone of a cornea. The disc is hydrated by the fluid agent, wherein the hydrated disc is pliable for conforming to a surface of the cornea. An application of the hydrated disc to the cornea substantially constrains the fluid agent to the determined zone and softens a corneal epithelium enabling delamination of the epithelium from an underlying stroma.

Abstract: An integrin antagonist reduces the occurrence of cross-linked actin network (CLAN) structures in cells of the trabecular meshwork. CLAN structures are associated with steroid-induced glaucoma. Reduction in CLAN structures is associated with increased aqueous humor outflow facility from the trabecular meshwork.

Abstract: The present disclosure provides copolymers including a first monomer including at least one phospholipid possessing at least one vinyl group and a second monomer including a furanone possessing vinyl and/or acrylate groups. Compositions, medical devices, and coatings including such copolymers are also provided.

Abstract: Biocompatible intraocular implants include a steroid and an auxiliary agent, where the auxiliary agent is present in an amount sufficient to lessen the severity of at least one side effect compared to the use of an otherwise identical implant lacking said auxiliary agent. The steroid and the auxiliary agent may be present on the same intraocular implant or on different implants. The steroid and auxiliary agent may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the steroid may be associated with a polymeric coating having one or more openings effective to permit the steroid to be released into an external environment. The implants containing the steroid and an auxiliary agent may be placed in an eye to treat one or more ocular conditions while reducing the side effects otherwise accompanying steroid use.

Abstract: Methods and systems are described for a rapid and sustainable change in the pigment melanin content of melanocytes of the iris stroma, thereby to change the color of the eye. Also described are nanoparticle compositions for lightening the pigmented tissues or treating a pigmented tissue related disease.

Abstract: A treatment solution used to prevent posterior capsular opacification is applied or introduced into the lens capsular bag before, during, or after cataract surgery. The treatment solution comprises an ion transport mechanism interference agent, which either alone or in combination with other treatment agents such as an osmotic stress agent and an agent to establish a suitable pH, selectively induces detachment and/or death of lens epithelial cells such that posterior capsular opacification is prevented. While the ion transport mechanism interference agent is capable of interfering with the cellular mechanisms and cell ion distribution of a broad range of cells, a concentration of agent is selected such that the treatment solution interferes selectively with the cellular mechanisms of lens epithelial cells while leaving other ocular cells substantially unharmed.

Abstract: This invention is in the area of medical devices, in particular in the area of medical devices for drug delivery, more in particular for controlled release of drugs to the eye. Delivery of drugs to the anterior side of the eye is routinely done with eye drops, but this method results in low bioavailability and low patient compliance. Devices that address these problems have been described for the delivery of drugs to the eye. One of such devices, called the OphthaCoil, consists of a thin metallic wire, which is coiled and carries a drug-loaded adherent hydrogel coating on its surface. Surprisingly it has now been found that the drug loading capacity can be dramatically increased by filling the lumen of the coil with micro-particles such as microspheres that contain the drug of choice.

Abstract: A method of treating an ophthalmic condition or disease by administering a compound disclosed herein is provided. The compound can be administered systemically or locally and in a variety of ways, such as via a temporary device, an implant, an injection or an eye drop. The compound can also be administered with an additional therapeutic agent.

Abstract: Disclosed are lacrimal inserts and their method of use for delivery of medication to the eye. The plug includes a body portion sized to pass through a lacrimal punctum and be positioned within a lacrimal canaliculus of the eyelid. The plug may contain a core, or reservoir, at least partially within the body portion comprising a therapeutic agent that is configured to controlled release into the eye.

Abstract: Disclosed are lacrimal inserts and their method of use for delivery of of medication to the eye. The plug includes a body portion sized to pass through a lacrimal punctum and be positioned within a lacrimal canaliculus of the eyelid. The plug may contain a core, or reservoir, at least partially within the body portion comprising a therapeutic agent that is configured to controlled release into the eye.

Abstract: This invention relates to compositions containing quaternary ammonium compounds in which the nitrogen atom is substituted by at least one alkyl group having at least 12 carbon atoms, characterized in that said composition includes at least 20% in weight by weight of the total composition, of ammonium halides in which the nitrogen atom is substituted by at least one alkyl group having at least 14 carbon atoms and more than 5%, preferably more than 7% in weight by weight of the total composition, of ammonium halides in which the nitrogen atom is substituted by at least one alkyl group having at least 16 carbon atoms. This invention also relates to ophthalmic oil-in-water emulsions containing such compositions, said ophthalmic emulsions being useful for eye care or for the treatment of eye conditions.

Abstract: A dispensing device having a polymer which is combined with a therapeutic agent in the form of a microparticle or nanoparticle which is “hyper-compressed” to form a controlled release dispensing device and methods of locally administering a therapeutic agent using said microparticles.

Abstract: The present invention is concerned with the formation of submicron particles of an antineoplastic agent, particularly paclitaxel, by precipitating the antineoplastic agent in an aqueous medium to form a pre-suspension followed by homogenization. Surfactants with phospholipids conjugated with a water soluble or hydrophilic polymer such as PEG are used as coating for the particles. The particles produced generally have an average particle size of less than about 1000 nm and are not rapidly soluble.

Abstract: Porous microperforators (210A), preferably in an array of multiple perforators are employed for delivery of a drug, where the micro-perforators may dissolve in situ. Suitable micro-perforators may include multiple layers of dissolvable materials to effect sequential drug delivery. In further aspects, contemplated micro-perforators may employ a diagnostic device in which a detector layer or detector is operationally coupled to the micro-perforators.

Abstract: A partially microcellular, selectively hydrophilic composite as a self-standing construct or a component of a device for ocular delivery of at least one bioactive agent, the composite comprising a highly hydrophilic microcellular foam adjoined with a flexible hydrophobic barrier polymeric film.

Abstract: Described herein are methods of inhibiting angiogenesis, and treating or preventing a disease or disorder (or symptoms thereof) associated with angiogenesis, wherein an anti-angiogenesis compound is administered to a subject.

Abstract: The invention provides a controlled release bioactive agent delivery device for treatment of an eye that includes a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension, and a polymeric coated composition in contact with a surface of the body member, the polymeric coated composition including a first polymer, a second polymer, and a bioactive agent. The first polymer and the second polymer are hydrophobic, and the body member has a length such that, upon placement of the device at an implantation site within a posterior segment of an eye, the device does not enter a central visual field of the eye. The invention also provides methods method of delivering bioactive agent to a posterior region of an eye.

Abstract: The invention provides micronized encapsulated cell therapy devices that are capable of delivering a biologically active molecule to the eye. Also provided are methods of using the same to deliver biologically active molecules to the eye and to treat ophthalmic disorders in patients suffering there from.

Abstract: This disclosure relates generally to methods and devices for use in treating eye conditions with implantable drug delivery devices. One method includes introducing an implant into the suprachoroidal space, wherein the interior volume of the implant is plugged with a drug-release material comprising at least one active agent that elutes through at least one opening in the implant, wherein the drug-release material degrades from the interior volume of the implant over a period time.

Abstract: The invention provides a controlled release bioactive agent delivery device that includes a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension, and a polymeric coated composition in contact with the body member, the polymeric coated composition including a first polymer, a second polymer, and a bioactive agent, wherein the first polymer comprises polyalkyl(meth)acrylate, aromatic poly(meth)acrylate, or a combination of polyalkyl(meth)acrylate and aromatic poly(meth)acrylate, and wherein the second polymer comprises poly(ethylene-co-vinyl acetate). The invention also provides methods of delivering a bioactive agent to a patient in a controlled release manner, as well as methods of making a controlled release bioactive agent delivery device.

Abstract: The invention relates to sustained release implants and to methods for treating eyes, particularly the eyes of mammals having eye disorders or diseases. By using the implants and methods described herein, the delivery of the one or more bioactive agents can be localized at a desired treatment site, particularly the choroid and the retina.

Abstract: The present disclosure provides copolymers including a first monomer including at least one phospholipid possessing at least one vinyl group and a second monomer including a furanone possessing vinyl and/or acrylate groups. Compositions, medical devices, and coatings including such copolymers are also provided.

Abstract: A biomedical device, such as a contact lens, has a surface linked to a polymer comprising boronic acid moieties. The boronic acid monomeric units may be derived from an ethylenically unsaturated monomer containing a boronic acid moiety, such as a vinylphenyl boronic acid or a (meth)acrylamido phenyl boronic acid. The boronic acid moieties may be complexed with mucin, especially epithelial mucin.

Abstract: The present invention provides materials that have high glucose and oxygen permeability, strength, water content, and resistance to protein adsorption. The materials include an interpenetrating polymer network (IPN) hydrogel that is coated with biomolecules. The IPN hydrogels include two interpenetrating polymer networks. The first polymer network is based on a hydrophilic telechelic macromonomer. The second polymer network is based on a hydrophilic monomer. The hydrophilic monomer is polymerized and cross-linked to form the second polymer network in the presence of the first polymer network. In a preferred embodiment, the hydrophilic telechelic macromonomer is PEG-diacrylamide, PEG-diacrylate or PEG-dimethacrylate and the hydrophilic monomer is an acrylic-based monomer. Any biomolecules may be linked to the IPN hydrogels, but are preferably biomolecules that support the growth of cornea-derived cells. The material is designed to serve as a corneal prosthesis.

Abstract: The present invention is directed to a pulsatile ophthalmic peri-corneal drug delivery device. The device includes an annular body and a mechanism for releasing multiple separate and distinct doses of a therapeutic composition over an extended period of time.

Abstract: The present invention is in the field of ophthalmic surgery and relates to a method for the prevention of capsular opacification, especially after extraction of the natural lens from the lens capsule of the eye. Particular methods disclosed include replacing the natural lens with a capsule filling implant comprising an injectable material and injecting an agent capable of inhibiting the proliferation of lens epithelial cells, migration of lens epithelial cells, and/or production of extra-cellular matrix by lens epithelial cells into a space between the inserted capsule filling implant and the lens capsule using an instrument having a hydrophobic outer surface such that the composition reaches a germinative zone of the capsular bag.

Abstract: Eye wall anchored fixtures each including at least one elongated anchor member for driven lengthwise insertion into an eye's eye wall in a transverse direction to its thickness for supporting an intraocular device in the eye's vitreous cavity. Fixtures are preferably anchored in circumferential incisions in a human adult eye's pars plana preferably 3.5 mm posterior to its corneal limbus, and perpendicular to a circumferential incision. The fixtures are either generally L-shaped with a single elongated anchor member designed for withdrawal from an eye wall or self-anchoring thereinto, or generally T-shaped with a pair of oppositely directed self-anchoring elongated anchor members for sealing a throughgoing incision. Intraocular devices can be designed for intraocular drug delivery, for acquiring intraocular physiological measurements, and the like.

Abstract: The invention provides implantable sustained release bioactive agent delivery devices that include a body member having a direction of extension, a longitudinal axis along the direction of extension, and a proximal end and a distal end, wherein at least a portion of the body member deviates from the direction of extension; and a polymeric coated composition in contact with a surface of the body member, the polymeric coated composition including a first polymer, a second polymer, and a bioactive agent. The polymeric coated composition is formulated to provide controlled release of bioactive agent over time when introduced into physiological conditions. Methods of preparing implantable devices configured and formulated to provide controlled release of bioactive agent are also provided.

Abstract: Composition containing quaternary ammonium compounds in which the nitrogen atom is substituted by at least one alkyl group having at least 12 carbon atoms, the composition including at least 20% in weight by weight of the total composition, of ammonium halides in which the nitrogen atom is substituted by at least one alkyl group having at least 14 carbon atoms and more than 5%, preferably more than 7% in weight by weight of the total composition, of ammonium halides in which the nitrogen atom is substituted by at least one alkyl group having at least 16 carbon atoms. Ophthalmic oil-in-water emulsions containing such compositions, the ophthalmic emulsions being useful for eye care or for the treatment of eye conditions are also disclosed.

Abstract: Featured is a method for instilling one or more bioactive agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising concurrently using at least two of the following bioactive agent delivery methods (A)-(C): (A) implanting a sustained release delivery device comprising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more bioactive agents subretinally; and (C) instilling (e.g., injecting or delivering by ocular iontophoresis) one or more bioactive agents into the vitreous humor of the eye.

Abstract: A method of treating an ocular disease in a subject using a corticosteroid with reduced incidence of intraocular pressure lowering surgery comprises injecting an intravitreal insert capable of providing a therapeutic effect for an extended period of time. The intravitreal insert delivers sustained sub-microgram levels of corticosteroid.

Abstract: A laminate comprising a transparent collagen I type sheet and a human corneal endothelial cell culture layer provided on the sheet. An endothelial cell culture layer laminate usable in transplantation is provided.

Abstract: A method of forming an ocular delivery device includes exposing a solid, shaped cellulose polymer to a solution including an active pharmaceutical ingredient (API) and a solvent capable of solubilizing the API, wherein the polymer absorbs at least a portion of the solution, including the API and solvent. The method may further include removing at least a portion of the absorbed solvent from the polymer by allowing the absorbed solvent to evaporate from the polymer or by drying the polymer. A variety of cellulose polymers may be used, including hydroxypropyl cellulose. A variety of APIs may be used, including Cyclosporine, Tobramycin and Vancomycin. Ocular delivery devices prepared by the methods may be used to treat a variety of eye disorders.

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 disposing on a target tissue and a well having an opening to the internal surface. An inner core comprising a drug containing portion and an expandable material is disposed in the well.

Abstract: The presently claimed and disclosed inventive concept(s) provides methods for reducing, reversing or inhibiting retinal cell degeneration, or neovascularization in tissues of a mammalian subject having a pathological condition involving neovascularization, by administration in vivo of nanoceria particles (cerium oxide nanoparticles) to the subject. The method of the presently claimed and disclosed inventive concept(s) is useful, for example, for reducing, treating, reversing or inhibiting degeneration of retinal cells such as photoreceptor cells or neovascularization in ocular tissue such as the retina, macula or cornea; or other tissues such as, but not limited to, skin, synovial tissue, intestinal tissue, or bone. In addition, the method of the presently claimed and disclosed inventive concept(s) is useful for reducing or inhibiting neovascularization in a neoplasm (tumors), which can be benign or malignant and, where malignant, can be a metastatic neoplasm.

Abstract: A contact lens solution comprising 0.001 to 10 weight percent or a preservative enhancer chosen from the group consisting of: D4E1, D2A21, and P-113; and at least 0.0001 weight percent of a preservative, and where the concentration of chloride in said solution is less than 0.2 percent by weight.

Abstract: An intraocular implant adapted to come in contact with the aqueous humor comprises a hydrophilic polymer having a predetermined water content for implantation in an eye, an effective quantity of a medicated product for treatment of the eye being dispersed in the mass of the hydrophilic polymer of the implant, the association of the hydrophilic polymer and the dispersed medicated product being adapted to release the product progressively into the aqueous humor.

Abstract: Ophthalmically therapeutic materials, such as liquid-containing compositions and polymeric drug delivery systems, include a therapeutic component which includes an alpha 2 adrenergic receptor agonist that is cleared from the anterior segment of an individual's eye to which the material is administered. The alpha 2 adrenergic receptor agonist may have a vitreal half-life greater than about three hours. The present materials are effective in treating an ocular condition(s) that affect the anterior segment of an eye, or the anterior and posterior segment of the eye. The materials are suitable for intravitreal or periocular administration and can provide prolonged drug delivery and therapeutic benefits to patients to which the materials have been administered. The alpha 2 adrenergic receptor agonists can be provided in liquid-containing formulations and/or bioerodible and/or non-bioerodible polymeric implants and microparticles. Methods of making and using the present materials are also described.