Total Tears

Imprimis Pharmaceuticals

Chondroitin sulfate/dextran/glycerol vehicle available with Cyclosporine 0.1% for all-around dry eye support

lindstrom-expert-headshot

Richard L. Lindstrom, MD

Cornea, Cataract and Refractive Specialist, Minnesota Eye Consultants

Expert Reviewer

At-a-Glance
  • Klarity vehicle contains chondroitin sulfate/dextran/glycerol which serves as a lubricant with anti-inflammatory properties
  • 0.1% cyclosporine concentration
  • Preservative-free drops in a multidose bottle
  • Cash-pay model eliminates hassles of coupon eligibility, preauthorizations, and pharmacy callbacks

Description

Total Tears is a portfolio of compounded formulations developed to address various aspects of dry eye disease (DED). Recognizable components within the products are chondroitin sulfate, dextran, glycerol and cyclosporine. The vehicle for the topical formulations is Klarity–a patented ophthalmic solution and gel technology designed by Richard L. Lindstrom, MD, for the treatment of ocular surface pathology associated with ophthalmic surgery, contact lens wear, and patients with mild to severe dry eye.

Klarity Drops Chondroitin sulfate/dextran/glycerol based vehicle with anti-inflammatory properties that protects and lubricates the cornea
Klarity C-Drops 0.1% concentration of cyclosporine for anti-inflammatory therapy of dry eye in a chondroitin sulfate/dextran/glycerol based vehicle with anti-inflammatory properties that protects and lubricates the cornea

Compounds Converging on Dry Eye

As an active ingredient, chondroitin sulfate protects and rehabilitates the ocular surface as a cell membrane stabilizer, deturgescent agent, free radical scavenger, and lubricant. Chondroitin sulfate has been studied as a lubricant in dry eye patients and found to prolong tear film break-up time and improve patient-reported symptoms.1 It has a long history of use in ophthalmic products where corneal tissue protection is vital, such as Optisol-GS (Bausch + Lomb), a corneal storage medium, Viscoat (Alcon) and DisCoVisc (Alcon) ophthalmic viscosurgical devices. Other ingredients include Dextran and Glycerol, also deturgescent agents, that enhance lubrication.

Klarity can be prescribed in a stand-alone formulation or with a 0.1% concentration of cyclosporine, called Klarity C-Drops. Valved bottle technology allows the preservative-free emulsions to be dispensed from a multidose bottle.

Ophthalmologists are familiar with cyclosporine as a commonly used immunomodulatory treatment for DED. The molecule has a low water solubility2,3 thus increasing the importance of an effective, well-tolerated vehicle. This emulsion contains a 0.1% cyclosporine concentration which is two times that of the commercially available ophthalmic cyclosporine agent in the US market. Several studies have demonstrated safety and efficacy of 0.1% cyclosporine4,5,6 and a branded medication has been in use in Europe since 2015.

Streamlined Prescription

Patients obtain the cyclosporine/chondroitin sulfate prescription as an out-of-pocket expense which eliminates the hassles of coupon eligibility concerns, time-consuming preauthorizations, and pharmacy callbacks sometimes shouldered by eye care practices when prescribing branded medications. Klarity C-Drops can be shipped in bulk from Imprimis’ 503B facility and dispensed by practices, or a prescription can be faxed or mailed in for an individual patient to be shipped directly to the patient’s home. Leveraging the cost-saving potential of compounding, the cyclosporine/chondroitin sulfate formulation is available to patients at $150.00 for three 5.5mL bottles when purchased individually, according to a price list on the company website (Accessed March 2018). Practices can obtain a discount when ordering bulk quantities. Depending on dosing regimen, each bottle should last one month.

Prescription Process: Klarity Versus Branded Cyclosporine

Testimonials

I have found Klarity C-Drops to be a great addition to my options for treating dry eye. The Klarity base is very comfortable and has been well tolerated with initial and continued use in my patients. The active component cyclosporine is very effective at a concentration of 0.1% and allows for consistent delivery of a medication that has been shown to be very effective in treating aqueous deficient dry eye. Compliance is good with this formulation, and patients are able to access this medication directly from Imprimis in a convenient and cost effective way. Because of this, my staff is spared the headaches of prior authorizations and denials from insurance companies, as well as phone calls from pharmacies that have limited our access to other medications for dry eye patients.

Bret Fisher, MD

Eye Center of North Florida, Panama City, FL

Klarity C-Drops have been a great addition to my practice. It is a combination of the cyclosporin along with the vehicle, which is made of chondroitin sulfate and glycerol. The vehicle acts as a fantastic lubricant and is very cornea friendly. The cyclosporin concentration of 0.1% provides great biocompatibility and as ophthalmologists we are familiar with its benefits with the wide use of Restasis.

Michael Greenwood, MD

Vance Thompson Vision, Sioux Falls, SD

I have been using compounded cyclosporine drops for the past 6 months. Of the patients I have placed on the medication, several improved significantly. For example, one patient had an OSDI score improvement from 68 to 31 at 1 month, as well as symptomatic relief. Patients appreciate the affordable cost. The prescription process is relatively simple, and patients can refill easily over the phone. Overall, I would continue to recommend compounded cyclosporine drops for future patients with moderate to severe dry eye.

Julia Nemiroff, MD

East Florida Eye Institute, Stuart, FL

Klarity C-Drops, the most recent iteration of Cyclosporine with a concentration of 0.1%, delivers the expected anti-inflammatory effect to the ocular surface in a comfortable vehicle. My early experience with Klarity C-Drops for ocular surface disease shows repeatable improvement in corneal staining and osmolarity. The ability to treat ocular surface disease with a higher concentration of CsA safely improves compliance and patient outcomes.

Ahmad M. Fahmy, OD

Minnesota Eye Consultants, Minneapolis, MN

Preservative-Free Bottle Technology

Delivery of a preservative-free solution is made possible by a unique bottle with a one way valve system that ensures no contaminated liquid can be reintroduced into the container after a drop has been dispensed. Intake of air to counterbalance egress of liquid takes place via a separate venting system with a silicone membrane. This bottle also has an easy-open, tamper-evident lid.

One Way Valve System

Prevent the risk of contamination



Controlled Flow

Active pressure, not gravity, initiates drop



Blue Tip

Focal point to help patients align the drop trajectory




One Way Valve System

Prevent the risk of contamination

Controlled Flow

Active pressure, not gravity, initiates drop

Blue Tip

Focal point to help patients align the drop trajectory


Company Information

Contact the company for additional information, availability, or pricing:

Imprimis Pharmaceuticals

imprimisrx.com

12264 El Camino Real, Suite 350

San Diego, CA 92130

References

1. Moon W A, Lee H, Shin K C, et al. Short term effects of topical cyclosporine and viscoelastic on the ocular surfaces in patients with dry eye. Korean Journal of Ophthalmology 2007; 21(4);pgs189-194.

2. J Med Chem. 1993 Nov 26;36(24):3757-64. Solvent-dependent conformation and hydrogen-bonding capacity of cyclosporin A: evidence from partition coefficients and molecular dynamics simulations. el Tayar N1, Mark AE, Vallat P, Brunne RM, Testa B, van Gunsteren WF.

3. Cyclosporine A delivery to the eye: A comprehensive review of academic and industrial efforts F. Lallemand et al. / European Journal of Pharmaceutics and Biopharmaceutics 117 (2017) 14–28

4. Ophthalmology. 2000 May;107(5):967-74. Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The Cyclosporin A Phase 2 Study Group. Stevenson D1, Tauber J, Reis BL.

5. Clin Ophthalmol. 2018 Feb 5;12:289-299. doi: 10.2147/OPTH.S150957. eCollection 2018.Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program. Pisella PJ1, Labetoulle M2, Doan S3, Cochener-Lamard B4, Amrane M5, Ismail D5, Creuzot-Garcher C6,7, Baudouin C8,9,10.

6. Br J Ophthalmol. 2010 Oct;94(10):1312-5. doi: 10.1136/bjo.2008.150011. Epub 2010 Aug 1. A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome.

Financial disclosures: Richard L. Lindstrom, MD, is a consultant to Imprimis Pharmaceuticals, Inc.