Ophthalmic Delivery Device And Ophthalmic Active Agent Containing Compositions

Abstract

The present invention provides a delivery device for administration of active agent (12) containing compositions into the suprachoroidal space or supraciliary space. The invention provides methods of treatment of an ocular disease or condition accordingly. The invention also provides active agent containing compositions for delivery into the suprachoroidal space or supraciliary space.

Description

CROSS REFERENCE TO OTHER APPLICATIONS[0001]This application claims priority of U.S. Provisional Application No. 62 / 309,350, filed 16 Mar., 2016. The following patent applications are incorporated by reference: PCT / EP2015 / 071520, PCT / EP2015 / 071522.BACKGROUND OF INVENTION[0002]Due to the unique anatomy and physiology of the eye, multiple barriers exist that prevent significant transport of drugs to ocular tissues. The blood vessels of the eye have restricted permeability due to the blood-ocular barriers that regulate intraocular fluid. Due to these blood-ocular barriers, systemically administered drugs do not reach significant concentration in ocular tissues. Drugs in topical drops administered to the corneal surface are mostly washed out by tears into the naso-lacrimal duct. While in the tear film, drugs have limited time to penetrate the cornea to reach the intraocular space. Some drugs may be delivered to the front, anterior portion of the eye by drops, but reaching significant the...

AI Technical Summary

Benefits of technology

The device ensures targeted delivery and prolonged action of the active agent by maintaining therapeutic concentrations in the posterior retina while reducing the risk of increased intraocular pressure, enhancing treatment efficacy for ocular diseases.

Problems solved by technology

While in the tear film, drugs have limited time to penetrate the cornea to reach the intraocular space.

Some drugs may be delivered to the front, anterior portion of the eye by drops, but reaching significant therapeutic concentrations in the posterior portion of the eye and the retina is generally not achieved with topical methods of administration.

Sub-conjunctival injections are used to place a drug depot under the outer layer of the eye, however the very high lymphatic flow in the conjunctiva leads to rapid transport of the drug away from the eye.

Sub-conjunctival injections are typically not effective to achieving high drug levels in the posterior portion of the eye.

Sub-Tenon's injections have been demonstrated to be useful for the administration of steroids, however many drugs do not achieve significant drug levels in the retinal tissues from sub-Tenon's injection.

The half-life of the drug is limited due to the fluid in the vitreous which continuously moves forward toward the anterior chamber.

Intravitreally administered drugs such as steroids are associated with complications of cataract progression due to drug exposure to the lens and increased intraocular pressure from drug exposure to the trabecular meshwork during anterior flow from the vitreous chamber.

Small drug particle sizes are ideal for migration in the suprachoroidal space or supraciliary space, however small drug particles release drug at a much faster rate thereby reducing the longevity of the drug treatment.

One potential problem with all injections of drug into the eye beneath the sclera is increased intraocular pressure (IOP) caused by the additional volume introduced into the eye.

The increased IOP may cause pain and potential damage to the optic nerve.

However, for larger volumes such as 0.1 ml with steroids, IOP increase may be significant and may cause an acute period of pain and loss of vision.

Images