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.
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.
CONTACTS
Sales and Marketing Contact:
John Saharek
jsaharek@imprimispharma.com
858.704.4298
Media Contact
Deb
Holliday
deb@pascalecommunications.com
412.877.4519
Investor Contact:
Bonnie
Ortega
bortega@imprimispharma.com
858.704.4587
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SOURCE Imprimis Pharmaceuticals, Inc.