Imprimis Pharmaceuticals and Cleveland Eye Clinic Announce Positive Findings of Evaluation of LessDrops™ Combination Eye Drop Formulations Following LASIK Surgery

SAN DIEGO and CLEVELAND, Feb. 3, 2015 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company focused on the development and commercialization of proprietary compounded drug therapies, and Cleveland Eye Clinic, today announced positive results of an investigator-initiated evaluation validating the use of Imprimis' proprietary combination topical formulations for patients post-LASIK surgery.  Imprimis plans to begin fulfilling prescription orders for LessDrops™ formulations by the end of February 2015.   

The evaluation of Imprimis' proprietary Tri-Moxi (triamcinolone acetonide and moxifloxacin hydrochloride) and Pred-Moxi (prednisolone acetate and moxifloxacin hydrochloride) combination eye drop formulations was led by William F. Wiley, M.D., Medical Director at the Cleveland Eye Clinic and its affiliated laser center Clear Choice Custom LASIK Center, in order to assess standard follow-up care measurements following LASIK surgery as well as drug quality assurance.  Dr. Wiley concluded that Imprimis' Tri-Moxi and Pred-Moxi combination eye drop formulations produced equivalent outcomes compared to standard follow-up care measurements observed in traditional post-LASIK eye drop treatments.  Dr. Wiley plans to submit detailed data of the findings for presentation at an upcoming ophthalmology industry meeting.

There were two active treatment arms with a total of 60 patients randomly receiving either one bottle of Pred-Moxi or Tri-Moxi topical drops.  Patients were instructed to use their randomized treatment four times a day for 1 to 2 weeks, depending on individual healing times, following their LASIK surgery.  Intraocular pressure, visual acuity, programmed refraction in both eyes, and manifest refraction in both eyes were measured at one week and one month post-surgery compared against pre-operation measurements.  Visual acuity was also measured at one day post-surgery.  No additional anti-infective or anti-inflammatory eye drops were prescribed.  There were no safety issues or adverse events and Imprimis' Tri-Moxi and Pred-Moxi eye drops were well-tolerated.  At week one, early in the healing response and during the time the medications were being used, 47% of the patients were seeing 20/15 and 82% were seeing 20/20 or better.  These percentages are comparable to what is seen with traditional post-LASIK eye drops.       

Dr. Wiley stated, "Post-operative drops for LASIK are designed to prevent infection and control the inflammatory healing response to allow for a safe and quick visual recovery.  We evaluated two of Imprimis' new 'LessDrops' formulations consisting of compounded Tri-Moxi and Pred-Moxi combination eye drops.  By combining the steroid and antibiotic medications together, we were able to provide excellent surgical outcomes and reduce our patients' use of eye drops following LASIK surgery by 50 percent.  Our staff enjoyed the convenience of ordering the medications directly from a single pharmacy source, allowing for the medications to be available at our LASIK center the day of surgery.  Also, our patients appreciated the convenience of having their medications available for them at our clinic.  In a highly competitive LASIK market, any convenience recognized by the patient can provide a marketing advantage to a practice.  Based on our findings, we intend to fully integrate LessDrops formulations into our LASIK practice."

Imprimis CEO Mark L. Baum stated, "We are pleased with the positive results of the Cleveland Eye Clinic evaluation of our proprietary Tri-Moxi and Pred-Moxi topical formulations for patients following LASIK surgery.  We look forward to making our novel combination LessDrops™ eye drop formulations available to patients and physicians by the end of February.  As the year progresses, we will add to our portfolio of high quality and affordable LessDrops topical formulations, delivering additional novel prescription choices for our customers." 

Current treatment regimens following LASIK, cataract and other ocular surgeries include two or more daily self-administered topical eye drops for up to 4 weeks.  It is well documented that current eye drop regimens can be confusing to patients, creating non-compliance issues and incorrect dosing.¹  Imprimis estimates that its combination Tri-Moxi and Pred-Moxi topical eye drop formulations can require up to 50% fewer drops to be administered by patients and may cost up to 75% less than current post-surgery drops regimens.  Importantly, Imprimis' topical compounded drops may be eligible for reimbursement to patients covered by both public and private insurance plans. 

ABOUT IMPRIMIS' OPHTHALMIC FORMULATIONS

Imprimis acquired the intellectual property for its patent-pending Dropless Therapy™ and other ophthalmic formulations in August 2013.  The company's SSP Technology™ allows for increased solubility of active pharmaceutical ingredients, creating small, uniform particle sizes which enable functionality as an injectable or use as a topical eye drop.

Currently, Imprimis provides proprietary compounded antibiotic and steroid formulations, Tri-Moxi and Tri-Moxi-Vanc, available in single, injectable intraocular doses administered during ocular surgery.  Since their inception, Dropless formulations have been prescribed for individual patients and administered in over 50,000 eye surgeries where, as a result of the surgery, there is inflammation and a chance for post-operative infection.  Imprimis plans to introduce its new proprietary combinations of Tri-Moxi and Pred-Moxi as eye drops for patients following LASIK, cataract and other ocular surgeries at the end of February 2015.   

All Imprimis formulations may be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.

ABOUT CLEVELAND EYE CLINIC

The Cleveland Eye Clinic is a full service state of the art ophthalmic practice which has been serving the Cleveland area since 1943.  The doctors are leaders in eye care education and dedicated to staying on the cutting edge of eye care technology.  They are active leaders in a number of professional organizations and lecture internationally.  Cleveland Eye Clinic specializes in the latest eye care technology and treatment for many eye conditions including cataract surgery, glaucoma, macular degeneration and dry eye.  For more information, please visit www.clevelandeyeclinic.com. 

ABOUT IMPRIMIS PHARMACEUTICALS

San Diego-based Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to delivering high quality and innovative medicines to physicians and patients at accessible prices.  Imprimis' business is focused on its proprietary ophthalmology and urology drug formulations.  The company's pioneering ophthalmology formulation portfolio is disrupting the multi-billion dollar eye drop market, addressing patient compliance issues and providing other medical and economic benefits to patients.  Imprimis expects to launch its urology business in 2015, which includes a patented formulation to address patients suffering from interstitial cystitis.  For more information about Imprimis, please visit the company's corporate website at www.ImprimisPharma.com; ophthalmology business website at www.GoDropless.com; and urology business website at www.DefeatIC.com.

SAFE HARBOR

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 risks and uncertainties related to Imprimis' ability to make commercially available its compounded formulations and technologies in a timely manner or at all; physician interest in prescribing its formulations; risks related to its compounding pharmacy operations; its ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of its formulations; its ability to obtain intellectual property protection for its assets; its ability to accurately estimate its 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 its 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.

¹ Hennessy AL, Ophthalmology, 2010

CONTACTS

Imprimis Investor Contact
Bonnie Ortega
[email protected]
858.704.4587

Cleveland Eye Clinic Contact:
William F. Wiley, M.D.
[email protected]
440.922.6722

Media Contact
Deb Holliday
[email protected]
412.877.4519

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SOURCE Imprimis Pharmaceuticals; Cleveland Eye Clinic; Clear Choice Custom LASIK Center

Related Links

http://www.ImprimisPharma.com