Imprimis Pharmaceuticals announced it is making compounded cyclosporine-based formulations for dry eye disease. The formulations, which will be packaged in a preservative-free bottle, are patent-pending and include "Klarity Drops," a patented formulation developed by ophthalmologist Richard L. Lindstrom, MD.
Imprimis’ therapy will cost 99 cents for a month’s supply, with refills will start at $79 a month. The company plans to start selling prescriptions on November 1. After the announcement on Thursday, shares of Imprimis Pharmaceuticals sky-rocketed as much as 91 percent, before retreating back to finish up about 28 percent.
"We believe dry eye disease patients can benefit from unique customized medications that are not commercially available," Mark L. Baum, CEO of Imprimis, said in a company news release. "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."
Imprimis is marketing the new formulation as a lower-cost alternative to Allergan's Restasis (cyclosporine ophthalmic emulsion 0.05%).
Meanwhile, Allergan said in a statement that it fully recognizes the value and legitimacy of traditional and legal compounding efforts, but added that Imprimis’ compounding business model puts patients at risk.
“Imprimis’ compounding business model, which involves mass manufacturing and distribution of unapproved new drugs under the guise of compounding, puts patients at risk by exposing them to drugs and combinations of drugs that have not been shown to be safe or effective,” Allergan said.
The Imprimis cyclosporine-based formulations are not FDA approved. However, Imprimis says the formulations are made from FDA-approved drug components and compounded in FDA-inspected facilities.