SAN DIEGO, May 5, 2016 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a pharmaceutical company focused on the development and commercialization of proprietary and customizable drug formulations, today announced plans to launch its IV Free™ MKO Melt™ conscious sedation formulations and new triple combination eye drop that includes nepafenac at the American Society of Cataract and Refractive Surgery (ASCRS) Congress in New Orleans, Louisiana, May 6 - 10, 2016.
IV Free Cataract Surgery
The company's patent-pending IV Free MKO Melt (midazolam, ketamine and ondansetron) compounded conscious sedation formulation is an alternative option to IV anesthetic that is administered sublingually to sedate patients undergoing ocular and other surgical procedures. The MKO Melt, in troche format, provides consistent and predictable dosing and allows for quick and easy administration, resulting in increased positive experiences for patients and staff. Traditionally, sedation medications for ocular surgery have been administered intravenously, which requires IV medications and supplies, and the need for additional staff to assist in preparation, administration and monitoring related to this process; all of these factors often cause delays and disruptions in the operating room. The formulations or variations thereof have been used in over 1,000 LASIK and cataract surgeries to date as part of the investigators evaluation process and a growing number of physicians have made the switch to IV Free conscious sedation which are now available for the low cost of $25.00 per two troche pack. For more information and to order the IV Free MKO Melt compounded formulation, please visit www.IVFree.com.
A co-developer of the MKO Melt, John Berdahl, MD, stated, "It is one of the best things we have done for the patient experience, not to mention the surgeon and nurses experience. I love the predictable level of sedation." In a recent article published in Ophthalmology Management, Dr. Berdahl added that less time struggling to start IVs means he can perform an extra surgery or two per day. He also believes drastically reducing the number of IVs used has saved his practice money as well.
Dr. William F. Wiley, Medical Director of Cleveland Eye Clinic and co-developer, commented, "With IV sedation, it seemed that the patients were entering the OR anxious and once that anxiety cycle began it was hard to reverse or break. With sublingual sedation, onset begins in the pre-op area and by the time the patient is being wheeled back to the OR, the patient is feeling good."
Ralph Chu, MD, a recent prescriber of the MKO Melt, noted in the same article that his patients are less anxious because they are not getting an IV. "About 85% of our patients can go IV-free even in this short time of our early adoption curve. IVs do take time and resources on the day of surgery in the ASC. Discharging patients has also been smoother as patients are awake more quickly after the surgery."
Mark L. Baum, CEO of Imprimis, stated, "It has been a pleasure working with Drs. Wiley and Berdahl and other pioneering ophthalmologists to bring this innovative formulation to market. The significant potential cost savings to physicians, patients, surgical centers and hospitals where ophthalmic surgery is performed is consistent with our vision of making novel drug formulations accessible to physicians and patients at affordable prices. We believe our patent-pending conscious sedation custom formulation has broad applications and we plan to pursue other significant large therapeutic markets that may benefit from our novel MKO Melt compounded medications including vasectomy procedures, colonoscopies, oral dental surgeries and other outpatient surgical procedures currently using traditional IV sedation methods. In fact, we will be introducing our IV Therapy to urologists and their staff at the American Urologist Association meeting taking place in San Diego May 6-10, 2016 where we will be exhibiting our urology offerings to attendees. There are millions of patients in the U.S. each year undergoing surgical and non-surgical procedures that could potentially benefit from our IV Therapy. It is our goal to pursue these additional opportunities in order to expand our market reach beyond ophthalmic surgeries."
Imprimis-Sponsored Panel Discussion and Reception
Imprimis will host an informational Conscious Sedation MKO Melt panel discussion and open house on Saturday, May 7, 2016 at 5:30 p.m. at the Wolfe's in the Warehouse, Marriott Convention Center, 859 Convention Center Boulevard, New Orleans. John Berdahl, MD (Sioux Falls, SD) and William F. Wiley, MD (Cleveland, OH) will moderate a diverse panel of distinguished ophthalmologists covering topics including the new IV Free Conscious Sedation MKO Melt, Dropless Therapy and LessDrops. Panelists include: Bret L. Fisher, MD (Panama City, FL), Jeffrey Liegner, MD (Sparta, NJ) and Sydney Tyson, MD. (Vineland, NJ). The one-hour panel discussion will be followed by interactive question and answer sessions. To register for the event please visit www.dropless.com/event.
New Triple Drop Combination Formulation
Imprimis' also plans to introduce its new Pred-Moxi-Nepafenac (prednisolone acetate, moxifloxacin hydrocholoride and nepafenac) combination topical eye drop formulation at this week's conference. The company now offers four unique proprietary antibiotic, steroid and nonsteroidal combination LessDrops topical formulations: Pred-Moxi, Pred-Ketor, Pred-Moxi-Ketor and the new PredMoxi-Nepafenac for use following cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) and other ocular surgeries. This convenient and cost-effective approach alleviates the need for multiple postoperative eye drops and, in turn, helps to cut medication costs, improve compliance and enhance the patient experience. Current treatment regimens following ocular surgeries include two or more daily self-administered topical eye drops for up to four weeks. It is well documented that current eye drop regimens can be confusing for patients, creating non-compliance issues and incorrect dosing. Imprimis estimates that its LessDrops combination topical drops can require up to 50% fewer drops to be administered by patients and may cost up to 75% less than current post-surgery eye drop regimens.
John Saharek, Chief Commercial Officer of Imprimis, stated, "We are very pleased to be able to expand ophthalmologists' armamentarium of combination eye drops with Pred-Moxi-Nepafenac. Our LessDrops portfolio of topical formulations now provides an even wider array of nonsteroidal anti-inflammatory drug options for ophthalmologists to choose from when determining their patients' treatment protocols. We expect this portfolio to continue to expand in the future as we investigate additional combinations that address the unmet needs of the ophthalmic clinical community."
Imprimis' Ophthalmic Formulations
Patient compliance is of utmost importance and Imprimis believes its LessDrops formulations can 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 national leader in the development, production and dispensing of novel compounded pharmaceuticals. The company's two business programs, Imprimis Cares™ and Custom Compounding Choice™, focus on patient outcomes and affordability by offering high quality 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 company's corporate website at www.ImprimisPharma.com.
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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