These new options may be helpful for patients whose insurance does not cover Restasis and they cannot afford its cost. I have 15 patients who see a difference when they use Restasis (0.05% cyclosporin) and Xiidra, but it has been very difficult to get insurance to cover both.
Now generic 0.5% cyclosporin is coming out.
But wait, a new company with a patent wants us to use 0.09% cyclosporin, CEQUA: likely at same price tag as Restasis. 22% report pain when it enters they eye: similar to Restasis.
Also, below, a Compounding Pharmacy is selling Cyclosporin for less below.
WHAT STRENGTH CYCLOSPORIN SHOULD I USE?
I and many eye surgeons have patients who use Restasis 4x even though it is an “off label use”–as approved by the FDA. These patients note they feel improvement in their dry eyes when they use it 4x per day but not 2x/day–which is FDA approved.
Each patient may be different. The only way to know which % is best is to try the lowest & taper up if needed and try to taper back down if possible.
I have no doubt CEQUA will work for many patients, but before I consider CEQUA as a first line agent, I would like to see a CEQUA versus Xiidra, and CEQUA versus RESTAIS and CEQUA versus generic cyclosporin trial (1 eye CEQUA, the other eye the other med) showing CEQUA is superior to what we already have. CEQUA will likely do no harm long term given our long term findings with Restasis so far, but given the cost of CEQUA, not sure it is worth it yet.
For now, use the lowest % cyclosporin that helps. If the 0.5% 2x/day does nothing, I would try 4x/day: if this helps, I would try to see if CEQUA is less expensive. If 4x/day does nothing, I would switch to Xiidra.
CEQUA: is a 0.09% cyclosporin with “new” technology of using micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.
Cyclosporin is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). It is believed to work by decreasing the function of lymphocytes.[4] It does this by forming a complex with cyclophilin to block the phosphatase activity of calcineurin, which in turn decreases the production of inflammatory cytokines by T‐lymphocytes.[7]
Now generic 0.5% cyclosporin is coming out.
But wait, a new company with a patent wants us to use 0.09% cyclosporin, CEQUA: likely at same price tag as Restasis. 22% report pain when it enters they eye: similar to Restasis.
Also, below, a Compounding Pharmacy is selling Cyclosporin for less below.
WHAT STRENGTH CYCLOSPORIN SHOULD I USE?
I and many eye surgeons have patients who use Restasis 4x even though it is an “off label use”–as approved by the FDA. These patients note they feel improvement in their dry eyes when they use it 4x per day but not 2x/day–which is FDA approved.
Each patient may be different. The only way to know which % is best is to try the lowest & taper up if needed and try to taper back down if possible.
I have no doubt CEQUA will work for many patients, but before I consider CEQUA as a first line agent, I would like to see a CEQUA versus Xiidra, and CEQUA versus RESTAIS and CEQUA versus generic cyclosporin trial (1 eye CEQUA, the other eye the other med) showing CEQUA is superior to what we already have. CEQUA will likely do no harm long term given our long term findings with Restasis so far, but given the cost of CEQUA, not sure it is worth it yet.
For now, use the lowest % cyclosporin that helps. If the 0.5% 2x/day does nothing, I would try 4x/day: if this helps, I would try to see if CEQUA is less expensive. If 4x/day does nothing, I would switch to Xiidra.
CEQUA: is a 0.09% cyclosporin with “new” technology of using micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.
Cyclosporin is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). It is believed to work by decreasing the function of lymphocytes.[4] It does this by forming a complex with cyclophilin to block the phosphatase activity of calcineurin, which in turn decreases the production of inflammatory cytokines by T‐lymphocytes.[7]
Ciclosporin was isolated in 1971 from the fungus Tolypocladium inflatum and came into medical use in 1983.[8]
SLC
SLC
Sun Pharma Announces U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease
CEQUA (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic use is the first and only dry eye treatment to combine cyclosporine A with nanomicellar technology
Contacts
Sun Pharma
Investors:
Nimish Desai
Tel +91 22 4324 4324, Xtn 2778
Tel Direct +91 22 4324 2778
Mobile +91-98203 30182
nimish.desai@sunpharma.com
Investors:
Nimish Desai
Tel +91 22 4324 4324, Xtn 2778
Tel Direct +91 22 4324 2778
Mobile +91-98203 30182
nimish.desai@sunpharma.com
Imprimis Pharmaceuticals to Offer Compounded Cyclosporine Alternative to Restasis®
Initial prescriptions will be 99 cents for a one month supply with refills starting at $79 per month, including shipping
Imprimis Pharmaceuticals, Inc.
Oct 19, 2017, 07:30 ET
SAN DIEGO, Oct. 19, 2017 /PRNewswire/ — Imprimis Pharmaceuticals, Inc. (NASDAQ : IMMY ), an ophthalmology-focused pharmaceutical company, today announced 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.
ABOUT IMPRIMIS PHARMACEUTICALS
Imprimis Pharmaceuticals, Inc. (NASDAQ : IMMY ) is an ophthalmology-focused pharmaceutical company that produces and dispenses high quality innovative medications in all 50 states. Imprimis is dedicated to patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis produces and dispenses from both California and New Jersey. Imprimis is the largest shareholder of Eton Pharmaceuticals, Inc. (www.etonpharma.com), a company it spun out in 2017. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws.
Restasis® and all other trademarks, service marks and trade names included or referenced in this press release, are the property of their respective owners.
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