New Cyclosporin Options: Restasis goes Generic; CEQUA 0.09% cyclosporin; Compounded Pharmacy Cyclosporin may be an option also.

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. 

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]


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

MUMBAI, India & PRINCETON, N.J.–()–Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration. In the Phase 3 confirmatory trial on CEQUA, after 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment. CEQUA is dosed twice daily and will be available as a single-use vial.
The nanomicellar formulation technology uses 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.
“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of CEQUA represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. CEQUA, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”
Additionally, Jodi Luchs, MD, the principal investigator behind the CEQUA confirmatory Phase 3 trial, noted: “Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of CEQUA is welcomed news, and I look forward to offering my patients this compelling new option.”
CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.
About CEQUA™
CEQUA (cyclosporine A, ophthalmic solution) is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study, 744 patients with dry eye were treated either with CEQUA or its vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p<0.01). Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle, with some showing improvement as early as 1 month following treatment. Adverse events reported in the trial were mostly mild in nature. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated increased tear production (p<0.01) and was well tolerated by the study population. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis urinary tract infection, headache, and bronchitis.
CEQUA (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
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.
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 click for Full Prescribing Information & for more information visit
About Dry Eye Disease
Dry eye is a burdensome, chronic disease affecting millions of patients around the world, with a significant population, greater than 16 million patients, present in the United States.
Dry eye disease, as defined by the National Eye Institute (NEI, a division of the U.S. National Institutes of Health [NIH]), occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated. The disease causes a scratchy sensation or a feeling that something is in the eye. Other symptoms include stinging or burning, episodes of excess tearing following periods of stress, discharge, pain, and redness in the eye. The risk of developing dry eye increases with advancing age, and is more common in women than in men.
TM – All brand names and trademarks are the property of respective owners.
Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.
About Sun Ophthalmics
Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% in the U.S. Other candidates in Sun Ophthalmics’ development pipeline include Xelpros™ (latanoprost ophthalmic solution) 0.005% and DexaSite™ (dexamethasone) 0.1%. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at
About Sun Pharmaceutical Industries Ltd. (CIN – L24230GJ1993PLC019050):
Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma’s global presence is supported by 41 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 13 different classes of doctors with 32 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information, please visit & follow us on Twitter @SunPharma_Live.


Sun Pharma
Nimish Desai
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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 DIEGOOct. 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.
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. (, a company it spun out in 2017.  For more information about Imprimis, please visit the corporate website at
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 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.
John Saharek
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