Imprimis Pharmaceuticals to Offer Compounded Cyclosporine Alternative to Restasis

Imprimis Pharmaceuticals announced that it is making compounded Cyclosporine-based formulations available for physicians to consider prescribing as customizable and potentially lower-cost alternatives to Restasis®. Imprimis’ Cyclosporine-based compounded formulations, which will be packaged in a multi-use preservative-free bottle, are patent-pending and include “Klarity Drops™,” a patented formulation developed by renowned ophthalmologist Richard L. Lindstrom, MD.

Dry Eye Disease is estimated to affect up to 30 million Americans and is commonly characterized by irritated, gritty, scratchy or burning eyes, blurred vision, and feeling particles in the eye when there are none. Advanced Dry Eye Disease may damage the front surface of the eye and ultimately impair vision. The Imprimis Cyclosporine-based formulations, which are made from FDA-approved drug components and compounded in FDA-inspected facilities, require a patient specific prescription and may be customized according to patients’ individual needs.

Mark L. Baum, CEO of Imprimis stated, “We believe Dry Eye Disease patients can benefit from unique customized medications that are not commercially available. While physicians who use compounded Cyclosporine formulations have anecdotally known this for many years, there is now published data that demonstrates the clinical value of topical Cyclosporine formulations at concentrations greater than those currently available in commercially available medications. We are pleased to be able to offer affordable customized Cyclosporine formulations that are designed for patients’ individual needs.”

Baum added, “Imprimis has long championed issues of access, affordability and competition. While there are an estimated 30 million Americans suffering from Dry Eye Disease, only a small fraction of these patients receive therapy. Topical Cyclosporine, which is an off-patent and inexpensive drug, can cost more than $5,000 per year when it is purchased in the commercially available form of Restasis®. We believe that affordability can affect access to needed medications, and it is our hope that our formulations will allow more patients to gain access to a high quality customized Cyclosporine treatment option.”

In addition to this announcement, Imprimis will soon make publicly available a presentation on Surface Pharmaceuticals, Inc. Surface is a wholly owned subsidiary of Imprimis that is focused entirely on ocular surface disease, including Dry Eye Disease and Blepharitis. Surface has three core drug formulations based on two issued US patents and three pending patents, and intends to seek FDA-approval through the 505(b)(2) pathway for as many as five ocular surface disease and ophthalmic indications.