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.
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; Ahad
Mahootchi