Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for INVELTYS™ (KPI-121 1%)
-Kala seeks approval for its topical twice-a-day product candidate for the treatment of inflammation and pain following ocular surgery-
INVELTYS utilizes Kala’s proprietary Mucus Penetrating Particle (MPP) technology. MPPs are selectively-sized nanoparticles with proprietary coatings that significantly enhance drug penetration and distribution in ocular tissues. In pre-clinical studies, MPPs increased delivery into ocular tissues more than three-fold by facilitating penetration through the tear film mucus.
“INVELTYS administered twice-a-day to patients following cataract
surgery demonstrated statistically significant resolution of both
inflammation and pain in each of two Phase 3 clinical trials,” said
The NDA filing is supported by positive data from two Phase 3 trials.
The first Phase 3 clinical trial was designed to evaluate INVELTYS
administered twice-a-day and KPI-121 0.25% administered four times a day
for 14 days following cataract surgery. Statistical significance was
achieved for the primary efficacy endpoints of complete resolution of
inflammation at day 8 maintained through day 15 with no need for rescue
medication compared to placebo and complete resolution of pain at day 8
maintained through day 15 with no need for rescue medications compared
to placebo with both INVELTYS and KPI-121 0.25%. In
“The filing of the NDA for INVELTYS marks a major milestone for Kala in
advancing our mission of developing treatments for eye conditions using
our MPP technology,” said
About Post-Operative Inflammation and Pain
Ocular
inflammation and pain are common complications following ocular surgery.
According to Marketscope, in 2016 there were 7.7 million ocular
surgeries in
About INVELTYSTM (KPI-121 1%)
INVELTYS™
(KPI-121 1%) is a twice-a-day corticosteroid for the treatment of
inflammation and pain following ocular surgery. INVELTYS utilizes Kala’s
proprietary Mucus-Penetrating Particle (MPP) technology to enhance
penetration into target tissues of the eye. In pre-clinical studies, MPP
increased delivery of a corticosteroid into ocular tissues more than
three-fold by facilitating penetration through the tear film mucus.
INVELTYS has successfully completed two Phase 3 clinical trials and
achieved statistical significance for both primary efficacy endpoints
in both trials. Kala believes INVELTYS has a favorable treatment profile
compared to the standard of care for the treatment of inflammation and
pain following ocular surgery, due to its twice-a-day dosing regimen and
rapid onset of relief. In each of these trials, INVELTYS was well
tolerated with no treatment-related serious adverse events observed.
About Kala Pharmaceuticals, Inc.
Kala is a
biopharmaceutical company focused on the development and
commercialization of therapeutics using its proprietary
Mucus-Penetrating Particle (MPP) technology, with an initial focus on
the treatment of eye diseases. Kala has applied the MPP technology to a
corticosteroid designed for ocular applications, resulting in two
product candidates in Phase 3 clinical development, INVELTYSTM
(KPI-121 1%) for the treatment of inflammation and pain following ocular
surgery and KPI-121 0.25% for the temporary relief of the signs and
symptoms of dry eye disease.
Forward Looking Statements
This press release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, that involve substantial risks and
uncertainties including statements regarding the development and
regulatory status of the company's product candidates, including INVELTYSTM
(KPI-121 1%) for the treatment of inflammation and pain following ocular
surgery and KPI-121 0.25% for the temporary relief of the signs and
symptoms of dry eye disease. All statements, other than statements of
historical facts, contained in this press release, including statements
regarding our strategy, future operations, future financial position,
future revenue, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking statements,
and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements we make. For a discussion of the risks and uncertainties, and
other important factors, any of which could cause our actual results to
differ from those contained in the forward-looking statements, see the
"Risk Factors" section, as well as discussions of potential risks,
uncertainties and other important factors, in our Quarterly Reports on
Form 10-Q and other filings we make with the
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Source:
Investor and Media Contact:
MacDougall Biomedical
Communications
Cammy Duong, 781-591-3443
cduong@macbiocom.com