Unique NCELL® Technology and formulation provide superior delivery over cyclosporine emulsion 0.05%1,2

Encapsulates. Penetrates. Delivers.1,3-5

  • The novel NCELL Technology of CEQUA® cyclosporine eye drops encapsulates cyclosporine in tiny spheres that have a hydrophobic core and hydrophilic outer layer
  • These nanomicelles penetrate the aqueous layer of the tear film, delivering cyclosporine directly to ocular tissues

Study Design

CEQUA is the first and only FDA-approved cyclosporine treatment delivered with NCELL Technology1,6

Ocular tissue distribution of cyclosporine was evaluated in a total of 26 female New Zealand White rabbits that received a single dose (administered to both eyes) of vehicle, cyclosporine 0.05% or 0.1% with NCELL Technology, or a commercially available cyclosporine 0.05% emulsion (Restasis®, Allergan). Pharmacokinetic parameters for cyclosporine exposure were assessed in tears, whole blood, and ocular tissues.1,2

Watch NCELL Technology in action

 

 

MECHANISM OF DELIVERY

The nanomicelle is equipped for the journey

Delivering cyclosporine to ocular tissues, NCELL Technology encapsulates the cyclosporine, allowing it to penetrate the aqueous layer of the tear film.1,2

NCELL encapsulates: Polymers self-assembling into a hydrophobic core

NCELL Encapsulates

NCELL Technology uses nanomicelles composed of a blend of polymers.

These polymers self-assemble into the hydrophobic core protecting the cyclosporine so it isn’t released in the aqueous layer of the tear film.1,4

NCELL penetrates: nanomicelle penetrating the aqueous layer of the tear film

NCELL Penetrates

The small size facilitates entry into corneal and conjunctival cells.

Nanomicelles are able to penetrate the aqueous layer of the tear film because of their hydrophilic outer layer.1,3,4

NCELL delivers: nanomicelle breaking up to release cyclosporine, helping to improve the ocular surface

NCELL Delivers

The nanomicelles then break up to release cyclosporine for penetration into ocular tissues.3,4

Once released, cyclosporine gets to work to reduce inflammation, helping improve the ocular surface and increase tear production.2,4

ANATOMY OF NCELL

Overcoming aqueous solubility

NCELL is engineered to address cyclosporine solubility challenges to better reach the ocular surface.1,3 By using a protective hydrophilic shell, NCELL Technology delivers encapsulated cyclosporine in a secured hydrophobic core to the ocular surface.1,3-5

Hydrophilic Shell

This protective hydrophilic shell allows for transport through the tear film onto the ocular surface.1,3,4

NCELL with both the hydrophilic shell and hydrophobic core visible
Hydrophobic Core

This secured hydrophobic core prevents the encapsulated cyclosporine from being released until after penetrating the aqueous layer of the tear film.1,3-5

WHY NCELL MATTERS

Enhanced penetration of NCELL Technology2

Designed to protect cyclosporine during its delivery to the ocular surface.1,3,4

 

Up to 3x CsA concentration across the ocular tissues, see reference 2

NCELL provided superior delivery over emulsion

In a single-dose, preclinical study of cyclosporine delivered with NCELL Technology (0.05%) vs a commercially available cyclosporine emulsion (0.05%)1,2

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Indications and Usage

CEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Important Safety Information

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

Adverse Reactions

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please see the Full Prescribing Information.

 

References: 1. US Patent 9,937,225 B2. 2. Data on file. Cranbury, NJ: Sun Pharmaceutical Industries, Inc. 3. Cholkar K, Gilger BC, Mitra AK. Topical, aqueous, clear cyclosporine formulation design for anterior and posterior ocular delivery. Transl Vis Sci Technol. 2015;4(3):1-16. 4. Mandal A, Bisht R, Rupenthal ID, Mitra A. Polymeric micelles for ocular drug delivery: from structural frameworks to recent preclinical studies. J Control Release. 2017;248:96-116. 5. Cholkar K, Patel A, Vadlapudi AD, Mitra AK. Novel nanomicellar formulation approaches for anterior and posterior segment ocular drug delivery. Recent Pat Nanomed. 2012;2(2):82-95. 6. CEQUA [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2022.

Indications and Usage

CEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Important Safety Information

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

Adverse Reactions

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please see the Full Prescribing Information.

© 2024 Sun Ophthalmics, a division of Sun Pharmaceutical Industries, Inc. All rights reserved.

CEQUA and NCELL are registered trademarks of Sun Pharmaceutical Industries Limited.

All other trademarks are the property of their respective owners.

PM-US-CQA-1124 07/2024