Abstract: Methods of treating an eye for an ocular condition such as placing a composite depot comprising a xerogel with embedded degradable particles into an anterior chamber of an eye to deliver a therapeutic agent. The xerogel is a hydrogel after exposure to intraocular fluid and is degradable. The degradable particles comprise the therapeutic agent and hydrolytically degrade in the anterior chamber to provide a controlled release of the therapeutic agent into the eye. Materials and processes for making depots are provided as well as alternative methods of their use.

Abstract: Provided herein are sustained release biodegradable intracanalicular inserts comprising a hydrogel and an active agent, methods of treating or preventing an ocular disease in a subject in need thereof by administering such inserts as well as methods of manufacturing such inserts.

Abstract: In certain embodiments, the invention is directed to a compound of formula I: wherein: X1 is selected from N or N+Y1; X2 is selected from NH or NY2; X3 is selected from NH or NY3; Y is selected from —CH2OCO(OCH2CH2)n1OM1; or —CH2OCO(CH2)n1aCOOH; Y2 is selected from —CH2OCO(OCH2CH2)n2OM2; or —CH2OCO(CH2)n2aCOOH; Y3 is selected from —CH2OCO(OCH2CH2)n3OM3; or —CH2OCO(CH2)n3aCOOH; n1, n1a n2a, n3 and n3a are independently 0 or an integer from 1 to 8; M1, M2 and M3 are independently selected from H, optionally substituted C1-6alkyl and optionally substituted aryl wherein at least one of X1, X2 and X3 is not N or NH; and pharmaceutically acceptable salts thereof.

Abstract: In certain embodiments, the invention relates to a sustained release biodegradable intracanalicular insert containing nepafenac dispersed in a hydrogel for the treatment of pain and inflammation. According to certain embodiments of the present invention, pain and inflammation is treated by administering a biodegradable insert into the superior and/or inferior canaliculus of the eye, wherein the insert provides sustained release of a nonsteroidal anti-inflammatory such as nepafenac that is effective for treating pain and inflammation in a patient, e.g., during a period of one or more weeks, with only a single administration, and without the need for removal of the drug-depleted insert.

Abstract: Provided herein are sustained release biodegradable intracanalicular insert comprising a hydrogel and cyclosporine, methods of treating or preventing an ocular disease in a subject in need thereof by administering such inserts as well as methods of manufacturing such inserts.

Abstract: A system (100) includes a first assembly (110A) and a second assembly (110B). The first assembly (110A) includes a body (120) forming a first interior volume, a plunger (130) comprising a first distal end disposed within the first interior volume, a wire comprising a first distal end secured to the first distal end of the plunger (130), and a plunger clip (140) configured to interface with the plunger (130) and the body (120) to prevent actuation of the plunger (130). The second assembly (110B) includes a cowl (150) forming a second interior volume, a needle comprising a hub and a shaft, and a cowl cap disposed partially within the hub to secure the implant in the shaft. A first distal end of the shaft is connected to the hub. The hub is disposed within the second interior volume. The shaft is configured to receive an implant.

Abstract: Methods of treating an eye for an ocular condition such as placing a composite depot comprising a xerogel with embedded degradable particles into an anterior chamber of an eye to deliver a therapeutic agent. The xerogel is a hydrogel after exposure to intraocular fluid and is degradable. The degradable particles comprise the therapeutic agent and hydrolytically degrade in the anterior chamber to provide a controlled release of the therapeutic agent into the eye. Materials and processes for making depots are provided as well as alternative methods of their use.

Abstract: Provided herein are sustained release biodegradable intracanalicular inserts comprising a hydrogel and an active agent, methods of treating or preventing an ocular disease in a subject in need thereof by administering such inserts as well as methods of manufacturing such inserts.

Abstract: Disclosed in certain embodiments is an intracanalicular injectable applicator device includes a body forming a cavity and a cannula coupled to a first distal end of the body. The cannula forms a channel that is aligned with the cavity of the body. The cannula is configured to store an intracanalicular injectable in the channel. The intracanalicular injectable applicator device further includes a tip structure coupled to the body. The tip structure is disposed around at least a portion of the cannula. A distal end of the tip structure is configured to dilate a lacrimal punctum by inserting the distal end of the tip structure into the canaliculus via the lacrimal punctum. The intracanalicular injectable applicator device further includes an actuating structure configured to push the intracanalicular injectable through the channel and the distal end of the tip structure into a canaliculus via a lacrimal punctum.

Abstract: Provided herein are sustained release biodegradable intracanalicular insert comprising a hydrogel and cyclosporine, methods of treating or preventing an ocular disease in a subject in need thereof by administering such inserts as well as methods of manufacturing such inserts.

Abstract: Provided herein are sustained-release biodegradable ocular hydrogel implants which are useful in the treatment of certain ocular conditions.

Abstract: Disclosed in certain embodiments is an intracanalicular injectable applicator device includes a body forming a cavity and a cannula coupled to a first distal end of the body. The cannula forms a channel that is aligned with the cavity of the body. The cannula is configured to store an intracanalicular injectable in the channel. The intracanalicular injectable applicator device further includes a tip structure coupled to the body. The tip structure is disposed around at least a portion of the cannula. A distal end of the tip structure is configured to dilate a lacrimal punctum by inserting the distal end of the tip structure into the canaliculus via the lacrimal punctum. The intracanalicular injectable applicator device further includes an actuating structure configured to push the intracanalicular injectable through the channel and the distal end of the tip structure into a canaliculus via a lacrimal punctum.

Abstract: Drug delivery using bio-affecting drugs, particularly with shape changing drug delivery devices. Embodiments are included for depots for delivery of a therapeutic agent that change from an elongated state ex vivo to a coil in vivo where the agent is released.

Abstract: Disclosed in certain embodiments is an intracanalicular injectable applicator device includes a body forming a cavity and a cannula coupled to a first distal end of the body. The cannula forms a channel that is aligned with the cavity of the body. The cannula is configured to store an intracanalicular injectable in the channel. The intracanalicular injectable applicator device further includes a tip structure coupled to the body. The tip structure is disposed around at least a portion of the cannula. A distal end of the tip structure is configured to dilate a lacrimal punctum by inserting the distal end of the tip structure into the canaliculus via the lacrimal punctum. The intracanalicular injectable applicator device further includes an actuating structure configured to push the intracanalicular injectable through the channel and the distal end of the tip structure into a canaliculus via a lacrimal punctum.

Abstract: Provided herein are sustained release biodegradable intracanalicular insert comprising a hydrogel and cyclosporine, methods of treating or preventing an ocular disease in a subject in need thereof by administering such inserts as well as methods of manufacturing such inserts.

Abstract: The present invention is directed to a method of preparing a sustained release biodegradable ocular insert or implant comprising melt extruding or injection molding a polymer composition and an active agent to form an insert or implant suitable for administration to the body. e.g., ocular administration. The method comprises feeding the polymer composition and the active into an extruder; mixing the components in the extruder; extruding a strand; and cutting the strand into unit dose inserts or implants.

Abstract: A system (100) includes a first assembly (110A) and a second assembly (110B). The first assembly (110A) includes a body (120) forming a first interior volume, a plunger (130) comprising a first distal end disposed within the first interior volume, a wire comprising a first distal end secured to the first distal end of the plunger (130), and a plunger clip (140) configured to interface with the plunger (130) and the body (120) to prevent actuation of the plunger (130). The second assembly (110B) includes a cowl (150) forming a second interior volume, a needle comprising a hub and a shaft, and a cowl cap disposed partially within the hub to secure the implant in the shaft. A first distal end of the shaft is connected to the hub. The hub is disposed within the second interior volume. The shaft is configured to receive an implant.

Abstract: Serial-solvent biomaterials are described. Embodiments include materials made in an organic solvent that are stripped of the solvent and used in a patient, where they imbibe water and form a hydrogel. These materials are useful for, among other things, delivering therapeutic agents, tissue augmentation, and radiological marking.

Abstract: The invention relates to a sustained release biodegradable ocular implant containing a tyrosine kinase inhibitor dispersed in a hydrogel for the treatment of a retinal disease for an extended period of time.

Abstract: Provided herein are sustained release biodegradable intracanalicular inserts comprising a hydrogel and an active agent, methods of treating or preventing an ocular disease in a subject in need thereof by administering such inserts as well as methods of manufacturing such inserts.