Imprimis Pharmaceuticals Looks to Expand its Ophthalmology Portfolio with LessDrops™
Proprietary topical compounded formulations offer the promise of significantly reducing the number of patient eye drop administrations as well as the high cost of eye drops typically required for traditional treatment
Results of an investigator-initiated evaluation of the company's Pred-Moxi and Tri-Moxi topical eye drops for patients following LASIK surgery expected to be announced by end of January 2015
SAN DIEGO, Jan. 8, 2015 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company focused on the development and commercialization of proprietary compounded drug therapies, today announced its plans to introduce proprietary triamcinolone acetonide and moxifloxacin hydrochloride (Tri-Moxi) and prednisolone acetate and moxifloxacin hydrochloride (Pred-Moxi) combination eye drop formulations for patients following laser refractive surgery, including LASIK and photorefractive keratectomy (PRK) surgery, cataract and other ocular surgeries.
The 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 For some high volume ocular surgeries, like PRK and LASIK, the company 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. A prospective evaluation of de-identified quality assurance data of the Tri-Moxi and Pred-Moxi topical formulations for patients following LASIK surgery enrolled in the fall of 2014 at the Cleveland Eye Clinic. Imprimis expects the results of this research to be announced by the end of January 2015.
Imprimis' ophthalmic compound formulations have been optimized for the isotonicity and pH most compatible with the eye. Imprimis' patent-pending drug formulations allow for increased solubility of active pharmaceutical ingredients, creating small, uniform particle sizes which enable functionality such as an injectable or use as a topical eye drop.
"We are pleased to make our Tri-Moxi and Pred-Moxi formulations available soon – as an eye drop. This is a new application of our proprietary compound drug formulations, which allows for the combination of active pharmaceutical ingredients that do not normally combine well for administration. To date, we have made this technology available in single-use injectable ophthalmic formulations, which numerous ophthalmologists have reported on at major clinical meetings. While 95% of leading ophthalmologists surveyed would prefer Dropless Therapy2, many in the U.S. and abroad continue to prescribe eye drops for their patients following cataract surgery and other ocular procedures. The current single-API steroid and antibiotic eye drop choices for physicians and patients create compliance and cost issues for each of the parties involved. As a result, and in an effort to build a bridge to a 'Dropless' future for procedures like cataract surgery and to address the need for LessDrops™ in procedures like LASIK, we are seizing upon the opportunity to dramatically reduce the number of eye drop applications and lower costs by using our compounded formulations," stated Imprimis CEO Mark L. Baum.
Baum concluded, "Imprimis believes in and is committed to quality, accessible innovation and solving unmet needs in the markets it serves. In 2015 and beyond, we look forward to continuing to introduce new applications of our proprietary formulations and technologies, particularly in ophthalmology, for injectable and topical applications."
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 LASIK
Over half of Americans require some form of vision correction and it is estimated that 43 million of these are candidates for refractive surgery. Nearly 96% of refractive procedures performed today are LASIK (laser in situ keratomileusis), an outpatient surgical procedure used to treat nearsightedness, farsightedness, and astigmatism. According to the American Academy of Ophthalmology LASIK was first approved for use by the FDA in 1999 and it has quickly become one of today's most popular elective procedures with an estimated 700,000 procedures being performed annually in the U.S.
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
2 Video interview survey of 21 leading ophthalmologists conducted at a leading industry meeting in June 2014 in Boston
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SOURCE Imprimis Pharmaceuticals
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