# US 2015/0148899 A1 · Sodium channel blocker delivery system with scleral lens

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- Number: US 2015/0148899 A1
- Document ID: US20150148899A1
- Status: Published application
- Kind: A1
- Application number: 14/611,421
- Filed: 2015-02-02
- Published: 2015-05-28
- Earliest claimed: 2009-09-10
- Assignees: Boston Foundation for Sight
- Applicants: Boston Foundation for Sight
- Inventors: Perry ROSENTHAL
- Web page: https://patentgrep.com/patent/US20150148899A1

## CPC

- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61F 2/145: {Corneal inlays, onlays, or lenses for refractive correction}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K 31/4164: 1,3-Diazoles
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A61K 47/30: Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- G02C 7/04: Contact lenses for the eyes (disinfection or sterilisation of contact lenses A61L12/00)
- 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)
- 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)
- G02C: SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES (trial frames for testing the eyes A61B3/04; goggles or eyeshields not having the same features as spectacles A61F9/00)

## Abstract

A scleral lens is provided with a sodium channel blocker or a sodium channel modulator disposed in the pre-corneal tear film between the scleral lens and the cornea. This system can be used to deliver sodium channel blockers or a sodium channel modulators not currently used because of poor bioavailability. Methods of using this sodium channel blocker delivery system or a sodium channel modulator delivery system are also disclosed.

## Claims

### Claim 1

A method of treating corneal neuropathic pain in the eye of a patient, the method comprising:
applying to the eye of a patient suffering from corneal neuropathic pain, a sodium channel modulator delivery system adapted for treatment of corneal neuropathic pain comprising:
(a) a scleral lens to be disposed on an eye of a patient, the scleral lens comprising:
an optic portion having a first curvature, and a scleral portion having a second curvature, wherein:
(i) the first curvature is adapted to cover a cornea of the eye creating a reservoir between the first curvature and the cornea without any contact between the first curvature and the cornea, and
(ii) the second curvature is adapted to align with the shape of a sclera of the eye, on which the second curvature rests; and
alternating the administration of a solution comprising lacosamide with the administration of a solution comprising at least one of bupivacaine, lidocaine, proparacaine, flecainide, tetracaine, ropivacaine, levobupivacaine, carbamazepine, and amitriptyline at an alternation interval.

### Claim 2 (depends on 1)

The method of claim 1, wherein the alteration is about one day to about fourteen days.

### Claim 3

A method of increasing the bioavailability of a sodium channel modulator at the eye of a person, the method comprising the steps of
applying a solution comprising a sodium channel modulator to the eye of a person;
applying a scleral lens on the eye of the patient, such that an optic portion of the lens having a first curvature covers a cornea of the eye and creates a reservoir for the solution between the first curvature and the cornea without any contact between the first curvature and the cornea and a scleral portion of the lens having a second curvature aligns with the shape of a sclera of the eye, on which the second curvature rests.

### Claim 4 (depends on 3)

The method of claim 3, wherein the solution comprises lacosamide.

### Claim 5 (depends on 4)

The method of claim 4, wherein the lacosamide is administered to the eye, then the scleral lens is applied to the eye.

### Claim 6 (depends on 4)

The method of claim 4, wherein the lacosamide is added to the scleral lens, then the scleral lens is applied to the eye.

### Claim 7 (depends on 4)

The method of claim 4, wherein the lacosamide is in the solution at a concentration of less than or equal to about 5% lacosamide.

### Claim 8 (depends on 4)

The method of claim 4, wherein the lacosamide is in the solution at a concentration of about 0.001% to about 5.0% lacosamide.

### Claim 9 (depends on 4)

The method of claim 4, wherein the lacosamide is in the solution at a concentration of about 0.5% to about 1.0% lacosamide.

### Claim 10 (depends on 4)

The method of claim 4, wherein the lacosamide is in the solution at a concentration of about 0.5% lacosamide.

### Claim 11 (depends on 4)

The method of claim 4, wherein the lacosamide is in the solution at a concentration of about 1.0% lacosamide.

### Claim 12 (depends on 4)

The method of claim 4, wherein the lacosamide is in the solution at a concentration of about 0.003% lacosamide.

### Claim 13 (depends on 4)

The method of claim 4, further comprising alternating the administration of the solution comprising lacosamide with the administration of a solution comprising at least one of bupivacaine, lidocaine, proparacaine, flecainide, tetracaine, ropivacaine, levobupivacaine, carbamazepine, and amitriptyline at an alternation interval.

### Claim 14 (depends on 13)

The method of claim 13, wherein the alternation interval is about one day to about fourteen days.

### Claim 15

A sodium channel modulator delivery system for increasing the bioavailability of a sodium channel modulator at the eye of a person comprising:
(a) a scleral lens to be disposed on an eye of a patient, the scleral lens comprising:
an optic portion having a first curvature, and a scleral portion having a second curvature, wherein:
(i) the first curvature is configured to cover a cornea of the eye to create a reservoir between the scleral lens and the cornea without any contact between the scleral lens and the cornea, and
(ii) the second curvature is shaped to rest on a sclera of the eye; and
(b) a solution comprising a sodium channel modulator.

### Claim 16 (depends on 15)

The sodium channel modulator delivery system of claim 15, wherein the solution comprises lacosamide.

### Claim 17 (depends on 16)

The sodium channel modulator delivery system of claim 16, wherein the lacosamide is in the solution at a concentration of less than or equal to about 5% lacosamide.

### Claim 18 (depends on 16)

The sodium channel modulator delivery system of claim 16, wherein the lacosamide is in the solution at a concentration of about 0.001% to about 5.0% lacosamide.

### Claim 19 (depends on 16)

The sodium channel modulator delivery system of claim 16, wherein the lacosamide is in the solution at a concentration of about 0.5% to about 1.0% lacosamide.

### Claim 20 (depends on 16)

The sodium channel modulator delivery system of claim 16, wherein the lacosamide is in the solution at a concentration of about 0.5% lacosamide.

### Claim 21 (depends on 16)

The sodium channel modulator delivery system of claim 16, wherein the lacosamide is in the solution at a concentration of about 1.0% lacosamide.

### Claim 22 (depends on 16)

The sodium channel modulator delivery system of claim 16, wherein the lacosamide is in the solution at a concentration of about 0.003% lacosamide.
