Abstract: Provided is a biodegradable ocular implant for sustained drug delivery, including a first layer comprising a first biodegradable polymer, wherein the first layer contains a drug dispersed or dissolved therein. A multi-layered biodegradable ocular implant is also disclosed.

Abstract: A process for producing a pharmaceutical suspension that comprises an active pharmaceutical ingredient (“API”) having low solubility, the process comprises: (a) preparing a first solution comprising a carboxy-containing vinyl polymer and a solvent; and (b) adding a compound of the API to said first solution under conditions of high-shear mixing for a time from about 5 minutes to about 5 hours, said compound being soluble in said solvent, thereby producing a suspension of particles of said API in a composition comprising said carboxy-containing vinyl polymer; wherein a concentration of said API in said suspension is higher than a solubility of said API in said solvent. The present invention also provides a suspension produced by such process.

Abstract: Systems and methods for monitoring eye health. The systems and methods monitor eye health by measuring scleral strain by way of an implantable monitor, a wearable monitor configured in eyeglasses, or an external monitor using a portable tablet computing device. Certain embodiments of the strain monitor may be utilized to measure the strain on any surface to which it is attached, including, but not limited to, the skin of a patient or the surface of a structure such as a building or a bridge.

Abstract: An apparatus to treat a cataract where the cataractous lens is pierced and the resulting opening is mechanically maintained using a lens system device such as a cylindrical lens, tubular lens, pinhole device, a stent or similar small diameter device, or where the device itself is the lens. The resulting passageway for visible light created in the cataractous lens allows light to better reach the retina, thus improving vision. This lens system device that can be placed into an in situ cataract provides for a much simpler surgical technique and reduces related pre and post operative procedures and potential complications. Intraocular lenses may also be used in concert with this invention. The apparatus and related methods can be applied to humans as well as animals.

Abstract: The invention provides novel pharmaceutical compositions based on semifluorinated alkanes which are useful as carriers for a broad range of active ingredients. Preferred active ingredients include poorly water-soluble and/or hydrolytically sensitive drug substances. The compositions are designed as suspensions and have superior physical properties which make them highly useful as pharmaceutical delivery systems. The compositions may be administered topically into the eye, or injected via the subcutaneous or intramuscular route. The invention further provides kits comprising such compositions.

Abstract: Provided herein are phenyl-guanidine derivatives for the inhibition of Rac1 which blocks its interaction with guanosine exchange factors (GEFs) belonging to the DBL family as agents for the treatment of aggressive and/or resistant tumors, as well as pharmaceutical compositions comprising them, their use in therapy and processes for their preparation.

Abstract: Flowable compositions and methods are provided for delivering a therapeutic agent at or near a target tissue site beneath the skin of a patient, the flowable composition comprising (i) a solvent and (ii) an effective amount of the therapeutic agent, the flowable composition being capable of hardening to form a drug depot at a physiological temperature or as solvent contacts bodily fluid at or near the target tissue site, wherein the drug depot is capable of releasing the therapeutic agent over a period of at least one day and the target tissue site comprises at least one muscle, ligament, tendon, cartilage, spinal disc, spinal foraminal space near the spinal nerve root, facet or synovial joint, or spinal canal.

Abstract: A methoxypolyethylene glycol-polylactic acid block copolymer is disclosed, the methoxypolyethylene glycol-polylactic acid block copolymer being a block copolymer formed by ring opening polymerization of D,L-lactide and methoxypolyethylene glycol. A mass ratio of the methoxypolyethylene glycol to the D,L-lactide is 1:0.55-0.65 or 1:0.73-0.89 or 1:0.91-0.99. A preparation method of the foregoing block copolymer is also provided. When the block copolymer is used as a carrier for preparing a drug micelle, the encapsulation efficiency of the drug micelle prepared after being re-dissolved by water can be greater than 90% at 12 hours.

Abstract: A therapeutic agent delivery system includes a therapeutic agent delivery platform and a therapeutic guest agent. The therapeutic agent delivery platform is capable of being implanted in a tissue being treated. The platform includes a substrate and at least one host molecule coupled to the substrate. The therapeutic guest agent is capable of reversibly coupling with the host molecule when administered to the tissue being treated. The reversible coupling is defined by the binding affinity between the host molecule and the therapeutic guest agent. The therapeutic guest agent is delivered at a rate determined by the affinity release rate between the host molecule and the therapeutic guest agent. The degradation rate of the therapeutic guest agent may be slower than the affinity release rate between the host molecule and the therapeutic guest agent.

Abstract: A method of treating stroke by administration of a novel sigma agonist is presented. Twenty-four hours after MCAO, systemic administration of several novel sigma agonists including: Bromo-DTG; Chloro-DTG; N,N?-di-1-Naphthylguanidine hydrochloride (NAGH); N,N?-di-p-Nitrophenylguanidine HCL (NAD) or vehicle were injected subcutaneously daily for 3 days. Rats treated with Bromo-DTG and Chloro-DTG had no significant improvements in any of the motor or cognitive tests while NAGH treated rats showed improved vertical movement and had significantly less motor asymmetry and bias than vehicle treated rats. Sigma receptor agonist NAGH also was found to exert its long-term neuroprotective effects by preserving both gray matter and white matter tracts. Both NAD and NAGH, when administered 24 hours after experimental stroke, reduced neural damage and enhanced behavioral recovery thirty days later which suggests that NAGH and NAD potentially extend the therapeutic window of stroke several fold over the current treatments.

Abstract: A composition includes: a continuous liquid phase including an acrylic monomer and an epoxy monomer; and a dispersed nanoparticulate including ZrO2 modified with an acrylic silane; and wherein the composition is transparent to visible light when coated on a lens. In addition, a method including the steps of: mixing an acrylic silane and a methanol-based ZrO2 sol to create a methanol-based silane-modified ZrO2 sol; then mixing at least an acrylic monomer, an epoxy monomer, and the methanol-based silane-modified ZrO2 sol to obtain the composition. The composition can be adapted for coating and curing onto another substrate, such as an ophthalmic lens.

Abstract: The present invention pertains to 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide or a pharmaceutically acceptable salt thereof, or 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-N-[5-(4-methyl-1H-imidazol-1-yl)-3-(trifluoromethyl)phenyl] benzamide or a pharmaceutically acceptable salt thereof, for the treatment of disorders mediated by alpha-carbonic anhydrase isoforms selected from intraocular hypertension (glaucoma), epilepsy, Lennox-Gastaut syndrome, altitude sickness, headaches, neurological disorders and obesity.

Abstract: Biocompatible intraocular implants may include a brimonidine free base and a biodegradable polymer associated with the brimonidine free base to facilitate the release of the brimonidine free base into an eye with the polymer matrix lasts a period of time of not more than twice the drug release duration, but more than the drug release duration.

Abstract: A drug insert is configured for use with an implant. The implant is configured for insertion into a lacrimal canaliculus. The drug insert includes a drug core comprising a therapeutic agent and a polymer; and a sheath body comprising material substantially impermeable to the therapeutic agent, wherein the drug core is positioned within the sheath body. The sheath body is configured to provide an exposed end of the drug core that releases therapeutic agent to an eye when the drug insert is disposed within the implant and the implant is positioned in the lacrimal canaliculus. A distal end of the drug core is sealed with a medical-grade adhesive.

Abstract: The present invention relates to ophthalmic solutions and devices comprising at least one water soluble polymer having a molecular weight of at least about 500,000 Daltons and comprising linear or branched polyether pendant groups having a molecular weight of at least about 300.

Abstract: A prosthetic capsular device configured to be inserted in an eye includes a housing structure and a ring structure. The housing structure includes a first side, a second side opposite the first side, a third side, a fourth side opposite the third side, a posterior side including a refractive surface, an anterior side opposite the posterior side, and a longitudinal axis. The first side, the second side, the third side, the fourth side, the posterior side, and the anterior side at least partially define a cavity configured to contain an intraocular device (e.g., an IOL). The anterior side includes an opening. The ring structure includes a ring structure portion extending radially outward from proximate one of an end of the first side and an end of the second side.

Abstract: Formulations and methods that provided enhanced bromfenac penetration into ocular tissue when topically administered, compared to the currently available BROMDAY™ formulation and method when topically administered. The formulations and methods did so while retaining the patient convenience of a once-daily administration and advantageously lowered the bromfenac concentration dosed to the patient.

Abstract: The present invention relates to ophthalmic solutions and devices comprising at least one water soluble polymer having a molecular weight of at least about 500,000 Daltons and comprising linear or branched polyether pendant groups having a molecular weight of at least about 300.

Abstract: A conformable covering comprises an outer portion with rigidity to resist movement on the cornea and an inner portion to contact the cornea and provide an environment for epithelial regeneration. The inner portion of the covering can be configured in many ways so as to conform at least partially to an ablated stromal surface so as to correct vision. The conformable inner portion may have at least some rigidity so as to smooth the epithelium such that the epithelium regenerates rapidly and is guided with the covering so as to form a smooth layer for vision. The inner portion may comprise an amount of rigidity within a range from about 1×10?4 Pa*m3 to about 5×10?4 Pa*m3 so as to deflect and conform at least partially to the ablated cornea and smooth an inner portion of the ablation with an amount of pressure when deflected.

Abstract: A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. The length of the channels extending from the first side to the second side may comprise an effective length greater than a distance across the porous structure from the first side to the second side. The therapeutic device may comprise a penetrable barrier to inject therapeutic agent into the device when implanted in the patient.

Abstract: The present invention aims to provide a ring-shaped device superior in the wearing comfort and intraocular stability while being worn on the eye. Provided is a ring-shaped device to be worn on the scleral surface, which is characterized in that it has an opening to expose the cornea and an intermediate portion between an inner edge portion and an outer edge portion has a maximum thickness.

Abstract: Particles, such as particles including a polymer including vinyl formal monomer units, and related compositions and methods, are disclosed.

Abstract: Infections of body tissues, particularly of the eye or of wounds, are treated by brief low-intensity irradiation with ultraviolet radiation in the UVC band. A suitable treatment device contains a light-emitting diode producing UVC radiation at a wavelength of about 265 nm, at a power output of 5 mW, directed on to a zone of tissue about 4 mm in diameter. An optical aiming system indicates the zone of tissue to be irradiated. Irradiation for periods as brief as 1 second has been found effective, which equates to a dose of 4 mJ/cm2 delivered to the tissue. Longer periods and higher intensities may be used for more resistant infections. Such irradiation may be delivered endoscopically to treat internal infections or to prevent infection during surgery. The device may be hand held or mounted to an ophthalmic slit lamp or other support.

Abstract: Lacrimal implants for treating diseases or disorders are disclosed. More particularly, lacrimal implants, methods of making such implants, and methods of treating ocular, respiration, inner ear or other diseases or disorders using such implants are disclosed.

Abstract: Punctal plugs for delivering therapeutic agents have a body, a portion into which the therapeutic agent is held, a winding about the body, and an enlarged portion or anchor at an end.

Abstract: A therapeutic system comprises an ocular insert placed on a region outside an optical zone of an eye. The ocular insert comprises two structures: a first skeletal structure and a second cushioning structure. The first structure functions as a skeletal frame which maintains positioning of the implant along the anterior portion of the eye and provides support to the second, cushioning structure. This first structure maintains the attachment of the therapeutic system to the anterior portion of the eye for at least thirty days. In some embodiments the first structure remains a constant size and shape, e.g. a ring shape, a ring with haptics, or a curvilinear ring that is confined to and restrainingly engages the inferior and superior conjunctival fornices so as to retain the implant within the tear fluid and/or against the tissues of the eye.

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: The present invention relates to a novel liquid composition comprised of piroxicam or its pharmaceutically acceptable salt (a non-steroid anti-inflammatory drug) and hyaluronic acid or its pharmaceutically acceptable salt (used for treatment of degenerative arthritis). Specifically, the invention provides a highly physicochemically stable liquid injection, comprising piroxicam and hyaluronic acid as active ingredients and ?-cyclodextrin or its derivative and polyethylene glycol as additives to enhance its physicochemical stability, and the preparation method thereof.

Abstract: This invention relates to an aqueous ophthalmic composition comprising (A) polyoxyethylene castor oil and (B) sesame oil. According to the aqueous ophthalmic composition of the present invention, defoaming time is reduced, preservative efficacy is enhanced and photostability is improved.

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: Compositions, and methods of using such compositions, useful for placement, for example injection, into the interior of human or animal eyes are provided. Such compositions include a therapeutic component, such as one or more corticosteroids, a biocompatible polymeric component, and a solvent component. The composition is in a fluid form before placement in the interior of an eye, and becomes less fluid after the composition is placed in the eye to form an extended or delayed release drug delivery element or system. The drug delivery element is formed by the dissipation of the solvent from the composition when the composition is placed in the interior of an eye. One example of a composition includes triamcinolone acetonide as a therapeutic agent. A method of treating an ophthalmic condition, or otherwise improving or enhancing vision of a patient, comprises placing the fluid composition in the interior of the eye. The method may be practiced by injecting the fluid composition into the interior of the eye.

Abstract: A gel formulation for use in filling a wound cavity and delivering active ingredient thereto, having a pH range of 6.5 to 7.5, low bioadhesive strength and cohesive integrity and being a PVA borate gel including an active ingredient and a modulator to bind borate and/or PVA in aqueous solution through a mono-diol or di-diol formation and reduces the pH of PVA-borate hydrogels. A suitable modulator is a sugar alcohol such as mannitol and the active ingredient, a medicament suitable for topical application such as a local anaesthetic and/or an antibiotic.

Abstract: Glaucoma can be treated by implanting an intraocular shunt into an eye. The eye has an anterior chamber and sclera. A shunt can be placed into the eye to establish fluid communication between the anterior chamber of the eye and a space between layers of the sclera.

Abstract: Punctal plugs for delivering therapeutic agents have a body, a portion into which the therapeutic agent is held, a winding about the body, and an enlarged portion or anchor at an end.

Abstract: This invention relates to devices, systems and methods for delivering preprogrammed quantities of an active ingredient to a biological system over time without the need for external power or electronics.

Abstract: Embodiments of this invention generally relate to systems and methods for optical treatment and more particularly to non-invasive refractive treatment method based on sub wavelength particle implantation. In an embodiment, a method for optical treatment identifies an optical aberration of an eye, determines a dopant delivery device configuration in response to the optical aberration of the eye, wherein the determined dopant delivery device is configured to impose a desired correction to the eye to mitigate the identified optical aberration of the eye by applying a doping pattern to the eye so as to locally change a refractive index of the eye.

Abstract: Lacrimal implants and related methods providing secure retention within the lacrimal punctum of an eye are described. The lacrimal implants can comprise a implant body configured for at least partial insertion through the lacrimal punctum and into a lacrimal canaliculus. The implant body can include a deformable retention structure that can be configured to substantially encapsulate an expandable retention element. In some examples, the expandable retention element can include a fluid absorbing material, which can be exposed to fluid such as via a fluid permeable retainer or a fluid permeable aperture. As the fluid absorbing material retains fluid (i.e., upon acceptance of fluid into the retention structure), its size increases and its shape can change to urge one or more portions of the retention structure outward, such as against a wall of the lacrimal canaliculus, thereby securely retaining the lacrimal implant within the punctum.

Abstract: The present invention relates to the use of a compound of Formula (IIV) or pharmaceutically acceptable salt or solvate, isomer or prodrug thereof in the manufacturing of a medicament for the treatment and/or prophylaxis of any of the diseases selected from the group consisting of macular degeneration, corneal neovascularization or angiogenesis, iris neovascularization or angiogenesis, retinal neovascularization or angiogenesis, diabetic proliferative retinopathy and non-diabetic proliferative retinopathy.

Abstract: A delivery device that allows for the sustained release of an agent, particularly useful for the sustained release of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. The delivery device is minimally invasive, refillable and may be easily fixed to the treatment area. The delivery device includes a hollow body with an inlet port at its proximal end for insertion of the agent, a reservoir for holding the agent and a delivery mechanism for the sustained delivery of the agent from the reservoir to the patient.

Abstract: The invention provides punctal plugs for the delivery of active agent to one or both of the tear fluid of the eye and to the nasolacrimal duct. The plugs of the invention have a body, a reservoir contained within the body, and optionally a collarette. The reservoir has at least one opening and contains a polymeric material and at least one active agent.

Abstract: The present invention is directed to the provision of pharmaceutical compositions. The compositions include a therapeutic agent and a relatively low amount of surfactant for providing higher bioavailability of the therapeutic agent. The compositions are particularly desirable as ophthalmic compositions in which the therapeutic agent is a prostaglandin such as travoprost and the surfactant is a vegetable oil such as castor oil.

Abstract: The invention provides small molecule drugs that are chemically modified by covalent attachment of a water soluble oligomer. A conjugate of the invention, when administered by any of a number of administration routes, exhibits characteristics that are different from the characteristics of the small molecule drug not attached to the water soluble oligomer.

Abstract: Some aspects of this disclosure relate to a method of treating an opthalmic disease affecting an eye of a patient comprising forming a covalently-crosslinked hydrogel in situ at a peri-ocular, intra-ocular, or intra-vitreal site for controlled release of a therapeutic agent.

Abstract: A method for forming an ocular drug delivery device includes the steps of: (1) forming a drug core containing an active agent, wherein the drug core has a barrier disposed all surfaces thereof except for a drug release surface which is left free of the barrier; (2) forming a drug release membrane over the drug release surface; and (3) forming the remaining portion of the device body by an overcast (overmold) process.

Abstract: A method and apparatus for administering an active agent such as a medicine to a subject, uses an ocular implant such as a punctal plug, to which the active agent has been applied. The implant is installed at the eye of the subject for administering the active agent via tissues of the eye.

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: The present invention provides a sustained release implant for intraocular use to treat elevated intraocular pressure, which implant is configured for intracameral or anterior vitreal administration to a patient with elevated intraocular pressure (IOP), said implant comprising a core of an antihypertensive agent surrounded by a polymer, which limits the rate of passage of the antihypertensive agent from the implant into the eye of said patient and said implant provides a linear rate of release of therapeutically effective amounts of said anti-hypertensive agent into the eye for a period of time of between 14 days and 365 days.

Abstract: 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. 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: The invention provides a method to treat or prevent posterior capsular opacification. The method comprises administering a therapeutically or prophylactically effective amount of a pharmaceutical composition comprising at least one kinase inhibitor. The kinase inhibitor inhibits p38 kinases, ERK kinases, and/or Src family kinases. The invention also provides an ocular device coated with at least one kinase inhibitor.

Abstract: A biomaterial mass is inserted through a punctum into a canaliculus in the lacrimal outflow system with a syringe. The mass has an outer cross section that is less than the inner cross section of the canaliculus. The mass absorbs liquid to swell to form a lacrimal filler or sealing mechanism. The lacrimal filler has an external cross section that conforms to the internal cross section of the canaliculus and a soft outer surface relative to the surrounding tissues to prevent erosion of the canaliculus lining. The lacrimal filler forms an occlusion that prevents the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness. The mass and syringe are provided in kit with a rubber stopper and, optionally, a punctal dilator, an injecting catheter, and an enzyme for dissolving or degrading the lacrimal filler at a later time.