Imprimis Pharmaceuticals Reports On Positive Clinical Findings Presented At The American Academy of Ophthalmology Annual Meeting

SAN DIEGO, Oct. 24, 2014 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a specialty pharmaceutical company focused on the development and commercialization of proprietary sterile and topical compounded drug formulations, today reported on clinical findings demonstrating the safety and benefits of Dropless cataract surgery and provided an update resulting from the recent American Academy of Ophthalmology (AAO) annual meeting held in Chicago, Illinois. The company also announced Dropless media coverage from AAO meeting, where it introduced a new white paper, titled, “Making Dropless Cataract Surgery Possible”.

Imprimis currently provides two proprietary compounded antibiotic and steroid formulations available in single, injectable intraocular doses administered during ocular surgery. The first formulation contains triamcinolone acetonide and moxifloxacin hydrochloride (Tri-Moxi formulation), and a second variation includes the added antibiotic vancomycin (Tri-Moxi-Vanc formulation). These proprietary formulations have been prescribed for individual patients and administered successfully in over 40,000 cataract surgeries and other eye surgeries where, as a result of the surgery, there is inflammation and a chance for post-operative infection.

M. Stewart Galloway, MD, presented, “Transzonular Steroid/Antibiotic as Cataract Prophylaxis: Retrospective Analysis of 2300 Patients”. In the study, Dr. Galloway evaluated 2,300 eyes from 2006 to 2013 to evaluate transzonular injection of a combination triamcinolone and moxifloxacin formulation, with and without vancomycin, (Tri-Moxi / Tri-Moxi-Vanc) to reduce the use of eye drops following phacoemulsification cataract extraction with IOL implantation. Due to diabetes mellitus, epiretinal membrane and premium IOL, 19% of the patients also received supplement topical NSAIDs. All patients were seen post-op on the same day (4-7 hours following surgery), at three to four weeks post-op, and at six months post-op. No patients developed endophthalmitis and 98% remained free from cystoid macular edema (CME) and inflammation.

Dr. Galloway’s conclusion stated, “Intravitreal triamcinolone-moxifloxacin had very low rates of inflammation and CME, and there were no cases of endophthalmitis in phacoemulsification. The advantages in using a single dose administered transzonularly during surgery include improved patient compliance, reduced costs to the patient, and decreased post-operative care. It also has a huge potential in third-world medicine, where post-op visits are rarely a possibility.”

A poster titled, “Macular Edema Following Intravitreal Triamcinolone as an Alternative to Post-cataract Anti-inflammatory Drops”, was presented by James S. Lewis, MD. In the study, Dr. Lewis evaluated 200 cataract procedures in 129 patients without pre-existing macular pathology, imaged with retinal OCT immediately following surgery and at one day, one week, one month, and two months following uncomplicated surgery. In ten cases (5%), he added a short course of topical steroid to enhance patient comfort. Dr. Lewis found a CME rate of 2% when transzonular triamcinolone was used in place of topical anti-inflammatory medications. The presentation noted that current literature reports CME rates are between 0% and 8% after uncomplicated cataract surgery using post-operative topical steroids and NSAIDs. None of the patients had clinical or OCT evidence of macular edema. Dr. Lewis concluded, “Transzonular triamcinolone acetonide is a safe alternative to post-operative topical steroids and NSAIDs for the prevention of CME in uncomplicated cataract surgery.”

Robert H. Osher, MD, introduced Dropless cataract surgery at a “The Cutting Edge” session. During the panel discussion, Richard L. Lindstrom, MD, an internationally recognized leader in cataract surgery, spoke about Dropless surgery and the significant cost savings to his patients.

At the “Better Surgery through Chemicals” session, Jeffrey Liegner, MD, presented “Intravitreal Steroids and Antibiotics for Dropless Cataract Surgery” and shared his clinical experiences, now having performed more than 4,500 Dropless surgeries.

In AAO media news, William Trattler, MD, was interviewed on EyeTubeTV, and discussed how Dropless cataract surgery helps with compliance and cost issues for patients. Richard B. Mangan, OD, was featured on EyeTubeOD and provided his views on why there was so much “buzz” around Dropless cataract surgery at this year’s AAO meeting. In addition, Imprimis also introduced its new white paper, titled, “Making Dropless Cataract Surgery Possible” to booth and event attendees. It is now available for download and provides a comprehensive summary of Dropless cataract surgery.

“We are extremely pleased with the positive clinical findings presented at the AAO meeting and the outpouring of interest from physicians and the media over Dropless cataract surgery,” said John Saharek, VP, Commercialization. “Momentum is building as more and more physicians embrace and adopt Dropless cataract surgery. We will be continuing our Go Dropless campaign at three upcoming ophthalmology meetings over the next few months, which will provide additional opportunities to meet with physicians and for them to share their Dropless cataract surgery experiences.”

Mark L. Baum, CEO of Imprimis, commented, “The excitement and interest in our Go Dropless campaign at this year’s AAO meeting was phenomenal and very motivating for our team. Physicians are increasingly becoming adopters of Dropless surgery and nearly all of them have reported they have no plans to return to traditional patient-administered post-surgery eye drops. It is exciting to witness how our Dropless surgery is changing the way physicians are performing cataract surgery and how it is creating a new market opportunity for other companies. Many leading surgical instrument providers are now introducing Dropless therapy cannulas to be used during cataract surgery with our Dropless formulations. We are making great strides in our marketing and sales efforts, and look forward to continuing to increase physician adoption and to making Dropless cataract surgery a standard of care.”

Drs. Galloway, Lewis and Liegner are paid consultants of Imprimis.

ABOUT DROPLESS OPHTHALMIC SURGERY FORMULATIONS

Imprimis acquired the intellectual property for its patent-pending dropless ocular surgery and other ophthalmic surgery formulations in August 2013. Injectable drugs are revolutionizing the management of cataract patients. They simplify the process and provide safeguards against bacterial infection and inflammation, reducing the dependence on drop therapy and as a result, decreasing overall costs. Patients no longer need to administer multiple drops daily, thereby largely eliminating patient non-compliance and errors associated with this approach. Dropless cataract surgery has tremendous potential benefit to patients, caregivers, surgeons, staff, and the healthcare system alike.

ABOUT IMPRIMIS PHARMACEUTICALS

San Diego-based Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a specialty pharmaceutical company dedicated to delivering high quality and innovative medicines to physicians and patients at accessible prices. Imprimis is pioneering a new commercial pathway using compounding pharmacies for the formulation and distribution of its proprietary drug therapies, which include formulations in ophthalmology and urology. For more information, please visit www.imprimispharma.com or www.GoDropless.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.

Investor Contact
Bonnie Ortega
bortega@imprimispharma.com
858.704-4587

Media Contact
Deb Holliday
deb@pascalecommunications.com
412.877.4519

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SOURCE Imprimis Pharmaceuticals, Inc.