Clinical Study of Imprimis Pharmaceuticals' Tri-Moxi-Vanc Dropless Therapy Formulation Show Statistically Significant Reduction in Cystoid Macular Edema in Patients Following Cataract Surgery

SAN DIEGO, May 12, 2016 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company dedicated to making drugs affordable again through its Branded Compounding™ business model, today announced the positive results of an investigator-initiated clinical study presented at the American Society of Cataract and Refractive Surgery (ASCRS) Congress in New Orleans, Louisiana, relating to the company's triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (Tri-Moxi-Vanc) Dropless Therapy® formulation.

Ahad Mahootchi, MD, the study investigator, stated, "We've found a combination that is undoubtedly better than what we were doing before.  Steroid and NSAID drops post cataract surgery resulted in a cystoid macular edema (CME) rate around 1.5%.  However, we have set a new bar for CME reduction by combining Tri-Moxi-Vanc with an NSAID drop.  This is the most significant reduction in CME post-cataract surgery that we have seen in quite some time."

The purpose of the study was to prospectively compare rates of post-operative CME using traditional steroid and NSAID drops with Dropless Therapy, (intravitreal Tri-Moxi-Vanc) combined with an NSAID drop. A total of 1,200 consecutive cataract surgeries were monitored for CME prospectively for 90 days post-op, excluding cases with pre-operative CME.  The results of the study revealed the CME rate was 1.5% in the historical group (n= 600) using NSAID and steroid drops post operatively.  The CME rate was 0.5% in the group (n=600) receiving Dropless Therapy (intravitreal Tri-Moxi-Vanc) with post-operative NSAID drops only, thereby achieving statistical significance (P=0.003) in CME prevention versus traditional steroid and NSAID drops.

Mark L. Baum, Chief Executive Officer of Imprimis, stated, "The positive findings of this study presented at the recent ASCRS Congress indicate a significant reduction in cystoid macular edema (CME) in post-cataract surgery patients with our injectable Dropless Therapy (Tri-Moxi-Vanc) and an added NSAID topical eye drop compared to the group of patients treated with traditional individual NSAID and steroid topical drops following surgery.  As a leading innovator and people-focused pharmaceutical company, we are pleased to be a part of the advancement of the field of ophthalmology, making important medicines available to physicians and their patients at affordable prices.  It is because of the positive patient outcomes after more than 200,000 procedures that more and more physicians are switching to Dropless Therapy, and we look forward to increasing adoption and to Dropless cataract surgery becoming an important part of the standard of care for the millions of Americans who have cataract surgery each year."

Imprimis' Ophthalmic Formulations

Patient compliance is of utmost importance and Imprimis believes its Dropless Therapy injectable and LessDrops® topical compounded formulations may help to alleviate patient compliance issues commonly reported after ocular surgery.  The sterile ophthalmic formulations are enabled by the company's patent-pending SSP Technology®, which allows for active pharmaceutical ingredients that ordinarily do not mix to solubilize into a predictable, well-distributed, micronized particle suspension.  The drug formulations are optimized for isotonicity and pH most compatible for ophthalmic use, either as injectable or topical therapies.  Every batch is tested for sterility prior to distribution and a complimentary copy of the test report is included with each prescription.

Imprimis' Dropless Therapy compounded antibiotic and steroid formulations, Tri-Moxi and Tri-Moxi-Vanc, are available in single, injectable intraocular doses administered by physicians following ocular surgery. Dropless Therapy may substantially reduce or eliminate the need for patient-administered eye drops following surgery, thereby largely eliminating patient non-compliance and dosing errors associated with post-operative care regiments.  Dropless Therapy can simplify the post-operative care process, provide safeguards against bacterial infection and inflammation, and decrease overall costs.  More information is available at www.GoDropless.com.

The company's LessDrops combination topical eye drops can significantly reduce the need for multiple postoperative drops required after ocular surgeries and, in turn, help to reduce medication costs.  Developed with patients' top-of-mind, LessDrops combination formulations aim to improve patient compliance and alleviate patient confusion with fewer drops, thereby better enabling patients to follow their prescribed post-operative regimen.  The LessDrops portfolio includes proprietary Tri-Moxi, Pred-Moxi, Pred-Moxi-Ketor and Pred-Moxi-Nepaf combination topical formulations for patient administration following LASIK, cataract, and other ocular surgeries.  For more information, please visit www.LessDrops.com.

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 IMPRIMIS PHARMACEUTICALS

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to making drugs affordable again through its Branded Compounding™ business model.  The company is focused on patient outcomes and affordability and offers high quality lower-cost custom compounded drugs in all 50 states.  Headquartered in San Diego, California, Imprimis owns and operates four dispensing facilities located in California, Texas, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisPharma.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 our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing its formulations; risks related to its 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 its formulations; our 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.

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SOURCE Imprimis Pharmaceuticals; Ahad Mahootchi

Related Links

http://www.ImprimisPharma.com