Abstract: Disclosed are devices and methods for treatment of eye disease. The suprachoroidal space is used as a conduit within which to place a drug delivery device. One such drug delivery device may be a tube, wicking element, bioabsorbable polymer structure, or other configuration of drug delivery substrate. The delivery device may include a port on the proximal end to assist in repeat injection, and may include a reservoir to either collect flow from the aqueous to concentrate it along the length of the device, or act as a repository for injected agent.

Abstract: Methods and apparatus can fit coverings to treat eyes. The treated eye may comprise a natural eye, for example an eye treated for refractive error with a contact lens, or an eye having an epithelial defect of the eye, such as an eye ablated with PRK refractive surgery. In many embodiments, the covering can be identified so as to provide improved flow of tear liquid under the covering. The covering can be identified based on an inner corneal curvature and an outer corneal curvature and one or more of a limbus sag height or a conjunctival sag height. The covering may form a chamber when placed on the eye to pump tear liquid under at least a portion of the covering. The covering may comprise 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.

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: 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: Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include a deformable inner portion and a deformable peripheral portion. When disposed over the optical region of an eye, the inner portion is configured so that engagement of the posterior surface against the eye deforms the posterior surface so that the posterior surface has a shape diverging form the refractive shape of the epithelium when viewing with the eye through the ophthalmic lens. The rigidity of the inner portion is greater than the rigidity of the peripheral portion and the ophthalmic lenses are configured to allow movement relative to the eye upon blinking of the eye and to be substantially centered on the optical region of the cornea following the blinking of the eye. Methods of correcting refractive errors of an eye such as astigmatism or spherical aberration using the ophthalmic lenses are also disclosed.

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: Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include an inner optic portion configured to be disposed over the optical region of the cornea and having a central portion disposed between an anterior portion and a posterior portion. The inner optic portions configured to at least partially diverge from the shape of the cornea to provide at least one lenticular volume between a posterior surface of the inner optic portion and the cornea. The central portion may be characterized by a thickness from 50 ?m to 900 ?m and a modulus form 20 MPa to 1500 MPa.

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: Bimodulus multifocal ophthalmic lenses for correcting presbyopia include an inner optic portion characterized by a rigidity greater than a rigidity of an outer peripheral portion. When applied to an eye, the ophthalmic lenses are configured to provide one or more lenticular volumes between the posterior surface of the lens and the cornea. The ophthalmic lenses are further characterized by features on a surface of the lens for improving multifocal visual acuity. The disclosure further relates to methods of correcting presbyopia using the ophthalmic lenses.

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: Described are implantable devices (105) and therapeutic agent delivery formulations for the sustained release of therapeutic agents. In one aspect, described is a device to treat an ocular condition of an eye. The device has a proximal region. A tubular body (115) is coupled to the proximal region and has an outer diameter configured to be inserted at least in part into the eye. A reservoir (130) is in fluid communication with the tubular body and has a volume sized to receive an amount of a formulation of a therapeutic agent. One or more outlets (135) are in fluid communication with the reservoir and configured to release therapeutic amounts of the therapeutic agent into the eye for an extended time when the one or more outlets are positioned inside the eye.

Abstract: The present disclosure includes compositions of a semi-crystalline or crystalline pharmaceutically active agent dispersed in a polymer matrix, in which the active agent is less degraded and, therefore, has lower level of impurities. The present disclosure further includes a method of reducing or preventing physical and chemical degradation of a semi-crystalline or crystalline active agent pharmaceutically active agent dispersed in a polymer matrix. A method of preparation of the composition is also included in this disclosure.

Abstract: Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include an inner optic portion configured to be disposed over the optical region of the cornea and having a central portion disposed between an anterior portion and a posterior portion. The inner optic portion is configured to at least partially diverge from the shape of the cornea to provide at least one lenticular volume between a posterior surface of the inner optic portion and the cornea. The central portion may be characterized by a thickness from 50 ?m to 900 ?m and a modulus form 20 MPa to 1500 MPa.

Abstract: The present disclosure is directed to a pharmaceutical delivery device useful for the treatment of ocular diseases and disorders through sustained release of therapeutic doses of a pharmaceutical agent, while increasing or reducing formation and/or accumulation of mucus.

Abstract: Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include a deformable inner portion and a deformable peripheral portion. When disposed over the optical region of an eye, the inner portion is configured so that engagement of the posterior surface against the eye deforms the posterior surface so that the posterior surface has a shape diverging form the refractive shape of the epithelium when viewing with the eye through the ophthalmic lens. The rigidity of the inner portion is greater than the rigidity of the peripheral portion and the ophthalmic lenses are configured to allow movement relative to the eye upon blinking of the eye and to be substantially centered on the optical region of the cornea following the blinking of the eye. Methods of correcting refractive errors of an eye such as astigmatism or spherical aberration using the ophthalmic lenses are also disclosed.

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: 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. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.

Abstract: Described is a process for making a dry and stable hemostatic composition, said process comprising a) providing a first component comprising a dry preparation of a coagulation inducing agent, b) providing a second component comprising a dry preparation of a biocompatible polymer suitable for use in hemostasis, c) mixing said first component and said second component under conditions effective to form a wet paste while essentially preventing degradation of the second component by said first component in a final container or transferring said wet paste into a final container, d) freezing and lyophilizing said paste in said container thereby obtaining a dry and stable hemostatic composition comprising said first and said second component in lyophilized form, and e) finishing said dry and stable hemostatic composition in said final container to a storable pharmaceutical device containing said first component and said second component in a combined form as a dry and stable hemostatic composition.

Abstract: Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include an inner optic portion having a scaffold between an anterior portion and a posterior portion. The scaffold is characterized by a substantially uniform thickness formed from a material characterized by a modulus that his higher than the modulus of the peripheral portion. Openings within the scaffold are filled with a low modulus material. When applied to an eye, the lenses are configured to provide one or more lenticular volumes between the posterior surface of the lens and the cornea. The disclosure further relates to methods of correcting refractive errors of an eye such as astigmatism or spherical aberration using the ophthalmic lenses.

Abstract: Methods and apparatus can fit coverings to treat eyes. The covering can be identified so as to provide improved flow of tear liquid under the covering. The covering can be identified based on an inner corneal curvature and an outer corneal curvature and one or more of a limbus sag height or a conjunctival sag height. The covering may form a chamber when placed on the eye to pump tear liquid under at least a portion of the covering. The covering may comprise 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 covering may comprise a material having high oxygen permeability, for example silicone, with a wettable coating disposed on at least an upper surface of the coating.