# US 9,005,099 B2 · Method and apparatus for the delivery of photochemical (cross-linking) treatment to scleral tissue

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- Number: US 9,005,099 B2
- Document ID: US9005099B2
- Status: Granted
- Kind: B2
- Application number: 13/396,454
- Filed: 2012-02-14
- Published: 2012-08-16
- Granted: 2015-04-14
- Earliest claimed: 2011-02-15
- Assignees: Seros Medical, LLC
- Applicants: Mark S. Blumenkranz; Edward E. Manche; Satish V. Herekar; Donald J. Eaton
- Inventors: Mark S. Blumenkranz; Edward E. Manche; Satish V. Herekar; Donald J. Eaton
- Web page: https://patentgrep.com/patent/US9005099B2

## CPC

- A61F 9/0017: {implantable in, or in contact with, the eye, e.g. ocular inserts}
- A61F 9/0079: {using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves}
- A61K 9/0051: {Ocular inserts or implants}
- A61K 31/525: Isoalloxazines, e.g. riboflavins, vitamin B2
- A61K 41/0038: {Radiosensitizing, i.e. administration of pharmaceutical agents that enhance the effect of radiotherapy (radiotherapy per se A61N5/10)}
- A61K 41/0057: {Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent}
- A61P 27/02: Ophthalmic agents
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Delivery systems and methods for delivering riboflavin (R/F) and UVA irradiation to the sclera are disclosed. The R/F is delivered and then activated with UVA irradiation through the use of LEDs or optical fibers, thereby causing cross-linking of the collagen tissue. Delivery systems include implantable structures which provide surfaces that conform to the sclera. The delivery systems include various types of structures for delivery of R/F onto the sclera surface. Additionally, the delivery systems include UVA sources which provide irradiation of R/F in sclera collagen tissue.

## Claims

### Claim 1

A method of treating progressive myopia comprising:
providing an apparatus that upon insertion will deliver a drug formulation comprising riboflavin to scleral ocular tissue of a sclera of an eye of a patient in need of treatment for progressive myopia;
inserting the apparatus through an opening in a conjunctiva to deliver to deliver the drug formulation to targeted regions of the scleral ocular tissue; and
allowing the drug formulation to diffuse from the apparatus into the targeted regions of the scleral tissue to soak the scleral tissue,
wherein the apparatus is disposed in and delivers the drug formulation to an equatorial region of the sclera beneath the rectus muscles and the four quadrants of the sclera between the rectus muscles,
wherein the drug formulation comprises riboflavin capable of being activated by UVA radiation for purposes of inducing cross-linking of scleral collagen tissue, and
wherein the crosslinking imparts and increase in biomechanical rigidity or stiffness to the treated ocular tissue to reduce, limit, and/or arrest elongation of the eye that is characteristic of the progressive myopia.

### Claim 2 (depends on 1)

The method of claim 1, wherein the apparatus is disposed in and delivers the drug formulation to an anterior segment of the sclera.

### Claim 3 (depends on 1)

The method of claim 1, wherein the apparatus is disposed in and delivers the drug formulation to a posterior segment of the sclera.

### Claim 4 (depends on 1)

The method of claim 1, wherein the apparatus contains channels for delivering the drug formulation onto a surface of the sclera, and thereby enabling the riboflavin to soak into collagen tissue of the sclera.

### Claim 5 (depends on 1)

The method of claim 1, wherein the apparatus includes a system to rinse excess drug formulation from the scleral surface after soaking.

### Claim 6 (depends on 1)

The method of claim 1, further comprising delivering UVA radiation to the targeted regions of the scleral tissue which cross-links scleral collagen tissue exposed to the delivered formulation which imparts the increase in biomechanical rigidity or stiffness to the treated ocular tissue which reduces, limits, and/or arrests elongation of the eye that is characteristic of the progressive myopia.