Imprimis Announces Multi-Center Clinical Trial for Dropless® TriMoxi™ (Triamcinolone Acetonide-Moxifloxacin for injection) Formulation in Canada
Published: Aug 01, 2018
Study to assess drug safety, patient preference and pharmacoeconomic measures in 200 routine cataract surgeries
SAN DIEGO, Aug. 1, 2018 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc.. (NASDAQ: IMMY) through its ImprimisRx ophthalmology business today announced its Canadian partner, Advanced Dosage Forms Inc., will begin enrolling patients at McGill University Health Centre (MUHC) for a clinical trial of Imprimis's leading Dropless® (Triamcinolone Acetonide-Moxifloxacin) formulation after a No Objection Letter was issued by Health Canada on January 4, 2018 and analytical tests required by Health Canada were completed July 11, 2018. Additional patients will begin enrollment for the trial at Hôpital Maisonneuve-Rosemont on August 22, 2018. The prospective, randomized, controlled cross-over study of 200 bilateral cataract surgery patients will measure the outcomes of TriMoxi™ in one surgical eye versus traditional eye drop therapy in the same patient for the other surgical eye. The study may further efforts for public insurance payment for the formulation in Canada and in other markets.
Mark L. Baum, CEO of Imprimis, stated, "We are pleased to begin this multi-center prospective clinical trial for our leading Dropless formulation at Canada's premier healthcare institutions, McGill University Health Centre and Hôpital Maisonneuve-Rosemont. The goal of the study is to clinically validate the experience of American ophthalmologists who have administered over seven hundred thousand doses of this formulation to cataract surgery patients over the past four years."
John Di Genova, CEO of Advanced Dosage Forms, added, "Dropless has the potential of reducing or eliminating the need for post-cataract surgery topical eye drops for patients with physical and mental disabilities and others who cannot bear the burden of applying eye drops hundreds of times after ocular surgery. In the past two years, since partnering with Imprimis, Canadian ophthalmologists have seen this formulation work for thousands of Canadians and we are pleased to be able to formally study TriMoxi at two of the leading Canadian healthcare institutions, and hopefully offer it more broadly in Canada and other markets."
Baum added, "Patients undergoing cataract surgery are often dealing with comorbidities that complicate post-surgical care for infection and inflammation. Whether the patient lacks support at home, has dementia, Alzheimer's, Parkinson's, or simply cannot adhere to complicated eye drop regimens, we have seen TriMoxi offer an important therapeutic option for ophthalmologists and their patients, and we are proud to have the opportunity to provide Canadians and the Health Canada system with TriMoxi, a great example of Imprimis's commitment to affordable pharmaceutical innovation."
Health Canada is a department of the government of Canada and is responsible for helping Canadians maintain and improve their health. Health Canada regulates drugs, medical devices, and other products, and ensures that high-quality health services are accessible, while working to reduce health risks.
About Dropless Therapy® (Triamcinolone Acetonide-Moxifloxacin)
Imprimis's Dropless Therapy® compounded antibiotic and steroid formulations are available in single, injectable intraocular dose vials. In January 2018, a study of Dropless was featured in the prestigious peer-reviewed Journal of Cataract and Refractive Surgery comparing outcomes for glaucoma patients undergoing cataract surgery while having a stent inserted who received Dropless and a standard post procedure drop regimen, with the results showing similar safety and efficacy outcomes (click here to see the article). Another study from March 2017 in Current Pharmaceutical Design found diminished medication compliance problems, cost savings, time savings for staff at doctors' offices, and no post procedure complications for patients receiving Dropless (click here to view the article or request a copy by emailing here). Additionally, based on data collected from the U.S. Centers for Medicare and Medicaid Services (CMS), a 2015 economic study found that prescribing Dropless instead of traditional drop therapy could save Medicare and Medicaid more than $7.1 billion over the ten year period from 2016-2025 in addition to saving patients $1.4 billion and state Medicaid programs $124 million, in addition to recurring cost savings for an indefinite period (click here to see the study). More information is available at http://www.imprimisrx.com/formulations/ophthalmology/dropless/.
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a commercial-stage pharmaceutical company based in San Diego, California. In addition to owning the nation's leading ophthalmology pharmaceutical compounding business, ImprimisRx, the Company holds large equity positions in Eton Pharmaceuticals, Surface Pharmaceuticals and Melt Pharmaceuticals, companies originally founded as subsidiaries of Imprimis. The Company also owns royalty rights in certain 505(b)(2) drug candidates being developed by Eton, Surface and Melt. For more information about Imprimis, please visit the Investor Relations section of the corporate website by clicking here.
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's 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.
Imprimis's Dropless® is a compounded formulation and is not FDA-approved. 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. Click on this link for additional information about Dropless (Triamcinolone Acetonide-Moxifloxacin) formulations.
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SOURCE Imprimis Pharmaceuticals, Inc.
Company Codes: NASDAQ-SMALL:IMMY