Gyroscope Therapeutics Limited

Orbit Biomedical Limited

Genentech, Inc.

Janssen Biotech, Inc.

F. Hoffmann-La Roche Ag

Benjamin L Ko

Brendan J Oberkircher

Michael F Keane

Isaac John Khan

Daniel W Price

Thomas Edward Meyer

Robert H Roth

Michel Bruehwiler

Nathan Daniel Grubbs

Saeed Sokhanvar

Daniel J Yasevac

Leah R Soffer

Christopher D Riemann

Daniel James Prenger

Geoffrey King

Paul D Gordon

Daniel J Abbott

Michael F Clem

Mark S Ortiz

Scott Albert Uhland

Clinton W Denlinger

James G Lee

Mark C Tsai

Jacob W Schubert

Denis P Turner

Franklin S Busch

Anna R Raymond

Samuel Ridgley

Eric Kennedy

Thomas E Meyer

Mark Hedgeland

Olivia Enneking

Thomas Gernetzke

Michael Auld

Jacob Schubert

Danielj Prenger

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, and an actuation assembly. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patient's eye. The actuation assembly is operable to actuate the needle relative to the cannula to thereby drive a distal portion of the needle along an exit axis that is obliquely oriented relative to the longitudinal axis of the cannula. The cannula may be inserted through a sclerotomy incision to position a distal end of the cannula at a posterior region of the eye, between the choroid and sclera. The needle may be advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer, adjacent to the area of geographic atrophy.

Method and apparatus for suprachoroidal administration of therapeutic agent

An apparatus includes a body, and anchoring feature, and a guide feature. The body is sized and configured to be positioned on an eye of a patient. The anchoring feature is configured to secure the body to the eye of the patient. The guide feature is configured to guide a cannula into a scleral incision formed in the eye of the patient along a path that is substantially tangential relative to the eye of the patient. The guide feature is sized and configured to allow the cannula to pivot laterally through a range of angular motion at the scleral incision.

Ocular cannula guide

An apparatus includes a body and a pair of rigid legs extending from the body. The body includes an engagement feature configured to engage a deployment instrument. The legs are parallel with each other. Each leg has a sharp tip. The legs both extend along a plane. The body defines a guide opening. The guide opening is oriented transversely relative to the plane associated with the legs. The guide opening is sized to receive a cannula having a generally flat profile. The guide opening is configured to guide the cannula through a sclerotomy at a substantially tangential orientation.

Guide apparatus for tangential entry into suprachoroidal space

Method and apparatus for subretinal administration of therapeutic agent

A method includes inserting a flexible cannula between a sclera and a choroid of an eye. The needle is advanced from a distal end of the flexible cannula, such that the needle pierces the choroid to access a subretinal space of the eye. The needle is used to deliver a first volume of leading bleb fluid to the subretinal space. The delivery of leading bleb fluid is ceased for a duration of time. After expiration of the duration of time, the needle is used to deliver a second volume of the leading bleb fluid to the subretinal space. The combination of the delivered first and second volumes of the leading bleb fluid causes a substantial portion of the retina to detach from the choroid. A therapeutic agent may then be delivered to the subretinal space in the region where the retina is detached from the choroid.

Method of delivering leading blebs and agent to subretinal space

An apparatus includes a body, a needle, a catheter, and an actuator assembly. The needle extends distally from the body. The needle has an inner wall defining a needle lumen. The needle lumen is in fluid communication with a fluid port of the body. The catheter is slidably disposed in the needle lumen. The catheter has a catheter lumen. The first actuator assembly is configured to translate the catheter within and relative to the needle. The apparatus may also include an actuator assembly that is configured to rotate the needle relative to the body. The apparatus may be used to first deliver a leading bleb of fluid to the subretinal space in a patient's eye via the needle. The apparatus may then be used to deliver a therapeutic agent to the subretinal space in the patient's eye via the catheter.

Sub-retinal tangential needle catheter guide and introducer

An apparatus includes a body, a cannula, and a needle. The cannula is flexible and extends distally from the body. The needle is slidably disposed in the cannula. The needle includes a sharp distal tip and a curved portion. The needle is configured to translate relative to the cannula between a proximal position and a distal position. The distal tip is configured to be positioned inside the cannula when the needle is in the proximal position. The distal tip is configured to be positioned outside the cannula when the needle is in the distal position. The needle is resiliently biased to extend along a curve through the curved portion.

Apparatus for subretinal administration of therapeutic agent via a curved needle

A method includes inserting a flexible cannula between a sclera and a choroid of an eye. The needle is advanced from a distal end of the flexible cannula, such that the needle pierces the choroid to access a subretinal space of the eye. The needle is used to aspirate fluid from the subretinal space. The fluid may be present from a retinal detachment, a macular hemorrhage, or other condition present before the procedure begins. The method may further include injecting the fluid in the subretinal space via the needle, in which case the fluid may be a balanced salt solution or other bleb fluid. The method may further include injecting a therapeutic agent into the subretinal space after aspirating the bleb fluid. The volume of injected bleb fluid may be greater than the volume of injected therapeutic agent.

Method of performing subretinal drainage and agent delivery

An apparatus includes a pad assembly, an injector assembly, an injector driver, and a fluid source. The pad assembly is sized and configured to be placed on a forehead of a patient. The injector assembly includes a body, a flexible cannula, and a needle. The body is configured to be removably secured to the pad assembly. The cannula is sized to be inserted through an incision in an eye of a patient. The needle is slidably disposed in the cannula. The injector driver is operable to drive the needle longitudinally relative to the flexible cannula. The fluid source assembly is in fluid communication with the needle.

Injection device for subretinal delivery of therapeutic agent

An apparatus includes an injector, a first fluid conduit, a second fluid line, and a control module. The injector includes a body, a flexible cannula, a flexible needle, and a sensor. The needle is configured to translate relative to the cannula. The sensor is operable to detect a position of the needle relative to the cannula. The first and second fluid lines are coupled with the needle. The control module is in communication with the sensor, with the first fluid conduit, and with the second fluid conduit. The control module is configured to provide delivery of a first fluid through the first conduit to the needle based on a signal from the sensor. The control module is further configured to provide delivery of a second fluid through the second conduit to the needle.

Apparatus and method to form entry bleb for subretinal delivery of therapeutic agent

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Cincinnati, OH, United States of America

Benjamin L Ko