SAN DIEGO, Aug. 1, 2018 /PRNewswire/ -- Imprimis
Pharmaceuticals, Inc. (NASDAQ: IMMY) through its ImprimisRx
ophthalmology business today announced its Canadian partner,
Advanced Dosage Forms Inc., will begin enrolling patients at
McGill University Health Centre (MUHC)
for a clinical trial of Imprimis's leading Dropless® (Triamcinolone
Acetonide-Moxifloxacin) formulation after a No Objection Letter was
issued by Health Canada on January 4,
2018 and analytical tests required by Health Canada were
completed July 11, 2018.
Additional patients will begin enrollment for the trial at Hôpital
Maisonneuve-Rosemont on August 22,
2018. The prospective, randomized, controlled cross-over
study of 200 bilateral cataract surgery patients will measure the
outcomes of TriMoxi™ in one surgical eye versus traditional eye
drop therapy in the same patient for the other surgical eye.
The study may further efforts for public insurance payment for the
formulation in Canada and in other
markets.
Mark L. Baum, CEO of Imprimis,
stated, "We are pleased to begin this multi-center prospective
clinical trial for our leading Dropless formulation at Canada's premier healthcare institutions,
McGill University Health Centre and
Hôpital Maisonneuve-Rosemont. The goal of the study is to
clinically validate the experience of American ophthalmologists who
have administered over seven hundred thousand doses of this
formulation to cataract surgery patients over the past four
years."
John Di Genova, CEO of Advanced
Dosage Forms, added, "Dropless has the potential of reducing or
eliminating the need for post-cataract surgery topical eye drops
for patients with physical and mental disabilities and others who
cannot bear the burden of applying eye drops hundreds of times
after ocular surgery. In the past two years, since partnering
with Imprimis, Canadian ophthalmologists have seen this formulation
work for thousands of Canadians and we are pleased to be able to
formally study TriMoxi at two of the leading Canadian healthcare
institutions, and hopefully offer it more broadly in Canada and other markets."
Baum added, "Patients undergoing cataract surgery are often
dealing with comorbidities that complicate post-surgical care for
infection and inflammation. Whether the patient lacks support
at home, has dementia, Alzheimer's, Parkinson's, or simply cannot
adhere to complicated eye drop regimens, we have seen TriMoxi offer
an important therapeutic option for ophthalmologists and their
patients, and we are proud to have the opportunity to provide
Canadians and the Health Canada system with TriMoxi, a great
example of Imprimis's commitment to affordable pharmaceutical
innovation."
Health Canada is a department
of the government of Canada and is
responsible for helping Canadians maintain and improve their
health. Health Canada regulates drugs, medical devices, and
other products, and ensures that high-quality health services are
accessible, while working to reduce health risks.
About Dropless Therapy® (Triamcinolone
Acetonide-Moxifloxacin)
Imprimis's Dropless Therapy® compounded antibiotic and steroid
formulations are available in single, injectable intraocular dose
vials. In January 2018, a study
of Dropless was featured in the prestigious peer-reviewed
Journal of Cataract and Refractive Surgery comparing
outcomes for glaucoma patients undergoing cataract surgery while
having a stent inserted who received Dropless and a standard post
procedure drop regimen, with the results showing similar safety and
efficacy outcomes (click here to see the article). Another study
from March 2017 in Current
Pharmaceutical Design found diminished medication compliance
problems, cost savings, time savings for staff at doctors' offices,
and no post procedure complications for patients receiving Dropless
(click here to view the article or request a copy by emailing
here). Additionally, based on data collected from the U.S.
Centers for Medicare and Medicaid Services (CMS), a 2015
economic study found that prescribing Dropless instead of
traditional drop therapy could save Medicare and Medicaid more than
$7.1 billion over the ten year period
from 2016-2025 in addition to saving patients $1.4 billion and state Medicaid programs
$124 million, in addition to
recurring cost savings for an indefinite period (click here to see
the study). More information is available at
http://www.imprimisrx.com/formulations/ophthalmology/dropless/.
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a
commercial-stage pharmaceutical company based in San Diego, California. In addition to
owning the nation's leading ophthalmology pharmaceutical
compounding business, ImprimisRx, the Company holds large equity
positions in Eton Pharmaceuticals, Surface Pharmaceuticals and Melt
Pharmaceuticals, companies originally founded as subsidiaries of
Imprimis. The Company also owns royalty rights in certain
505(b)(2) drug candidates being developed by Eton, Surface and
Melt. For more information about Imprimis, please visit the
Investor Relations section of the corporate website by clicking
here.
Forward-Looking Statements
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 our formulations; risks
related to our 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 our formulations; our ability to
obtain intellectual property protection for our assets; our ability
to accurately estimate our 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 our 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's 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.
Imprimis's Dropless® is a compounded formulation and
is not FDA-approved. Other than drugs compounded at a
registered outsourcing facility, all Imprimis compounded
formulations may only be prescribed pursuant to a physician
prescription for an individually identified patient consistent with
federal and state laws. Click on this link for
additional information about Dropless (Triamcinolone
Acetonide-Moxifloxacin) formulations.
Investor Contact
Jon
Patton
jpatton@imprimispharma.com
858-704-4587
Media Contact
Deb
Holliday
Holliday Communications, Inc.
deb@hollidaycommunications.net
412-877-4519
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SOURCE Imprimis Pharmaceuticals, Inc.