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Kala Pharmaceuticals Announces Dosing of First Patient in Phase 3 STRIDE 3 Trial of KPI-121 0.25% in Patients with Dry Eye Disease

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Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company
focused on the development and commercialization of therapeutics using
its proprietary mucus-penetrating particle (MPP) technology, today
announced that the first patient has been dosed in STRIDE 3 (Short Term
Relief In Dry Eye), its Phase 3 trial of KPI-121 0.25% for the
short-term treatment of dry eye disease.

"We are pleased to initiate the STRIDE 3 trial of KPI-121 0.25%. If
approved, KPI-121 0.25% could be the first FDA-approved product for the
short-term treatment of dry eye disease," said Kim Brazzell, Chief
Medical Officer. "The STRIDE 3 trial design reflects specific
modifications to the inclusion/exclusion criteria of our previous trials
to address key factors which we believe will improve the probability of
success. We anticipate reporting topline results in the fourth quarter
of 2019. We also continue to prepare for the potential approval and
launch of INVELTYSTM (KPI-121 1%), which has been granted a
target action date under the Prescription Drug User Fee Act (PDUFA) of
August 24, 2018, and which, if approved, is expected to be the first
twice-daily ocular corticosteroid indicated for the treatment of
post-operative ocular inflammation and pain."

STRIDE 3 Phase 3 Trial Design

The STRIDE 3 trial is a multicenter, randomized, double-blind, placebo
controlled, parallel-arm study comparing KPI-121 0.25% to placebo, each
dosed four times a day (QID) for 14 days, in approximately 900 patients
with dry eye disease. Subjects who meet initial screening and
inclusion/exclusion criteria undergo a 2-week run-in period with
placebo. Subjects who continue to meet inclusion/exclusion criteria
after the run-in are randomized to either KPI-121 0.25% or placebo. The
primary endpoint, Day 15 ocular discomfort severity, is based upon a
patient diary in which ocular discomfort is recorded daily over the
entire course of the trial using a visual analog grading scale. Topline
data from this study is expected in the fourth quarter of 2019.

About the KPI-121 0.25% Development Plan

In January 2018, Kala announced topline results for two Phase 3 trials
(STRIDE 1 and STRIDE 2), evaluating the safety and efficacy of KPI-121
0.25% versus placebo in patients with dry eye disease. KPI-121 0.25%
achieved statistical significance for the primary sign endpoint of
conjunctival hyperemia at Day 15 in the intent to treat (ITT) population
in both Phase 3 trials. KPI-121 0.25% also achieved statistical
significance for the primary symptom endpoint of ocular discomfort
severity at Day 15 in the ITT population in STRIDE 1 with a trend
towards a treatment effect in STRIDE 2. Statistical significance was
achieved in STRIDE 1 for the second primary symptom endpoint of ocular
discomfort severity at Day 15 in patients with a more severe baseline
discomfort, with a strong trend towards a treatment effect observed for
the same endpoint in STRIDE 2. Positive treatment effects were also
observed in both trials for the symptom endpoint of ocular discomfort
severity in the ITT population at Day 8, which was a key pre-specified
secondary endpoint. KPI-121 0.25% was well-tolerated in both Phase 3
trials with elevation in intra-ocular pressure, a known side effect with
topical corticosteroids, similar to placebo.

Kala plans to file a New Drug Application (NDA) with the U.S. Food and
Drug Administration (FDA) during the second half of 2018. The NDA will
include data from three clinical trials studying approximately 2000
patients, including one Phase 2 trial and two Phase 3 efficacy and
safety trials. In addition, based upon the recommendation of the FDA,
Kala has initiated the STRIDE 3 Phase 3 clinical trial evaluating
KPI-121 0.25% for the temporary relief of the signs and symptoms of dry
eye disease.

About KPI-121 0.25%

Kala is developing KPI-121 0.25% for the temporary relief of the signs
and symptoms of dry eye disease utilizing a two-week course of therapy
administered four times a day. Dry eye disease is a chronic, episodic,
multifactorial disease affecting the tears and ocular surface and can
involve tear film instability, inflammation, discomfort, visual
disturbance and ocular surface damage. KPI-121 0.25% utilizes Kala's
mucus-penetrating particle (MPP) technology to enhance penetration of
loteprednol etabonate (LE) into target tissue of the eye. In preclinical
studies, MPP technology increased delivery of LE into ocular tissues
more than three-fold compared to current LE products by facilitating
penetration through the tear film mucus. Kala has completed one Phase 2
and two Phase 3 clinical trials of KPI-121 0.25%. Kala believes that
KPI-121 0.25%'s broad mechanism of action, rapid onset of relief of both
signs and symptoms, favorable tolerability and safety profile and the
potential to be complementary to existing therapies, could result in a
favorable profile for the management of dry eye flares and other dry eye
associated conditions.

About Kala

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 lead
product candidates: INVELTYS™ (KPI-121 1%) for the treatment of
inflammation and pain following ocular surgery, for which an NDA has
been accepted for review by the FDA and given a target action date under
the Prescription Drug User Fee Act (PDUFA) of August 24, 2018, 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 Company's product candidates including INVELTYS (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, KPI-121 0.25% potentially being the first FDA-approved
product for the short-term treatment of dry eye disease, the anticipated
reporting of STRIDE 3 topline results in the fourth quarter of 2019, the
Company's plans to file an NDA for KPI-121 0.25% with the FDA during the
second half of 2018, and a target action date under the Prescription
Drug User Fee Act (PDUFA) of August 24, 2018 for INVELTYS. All
statements, other than statements of historical facts, contained in this
press release, including statements regarding the Company's 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. The Company may not actually achieve the plans,
intentions or expectations disclosed in its forward-looking statements,
and you should not place undue reliance on such forward-looking
statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements as a result of various risks and uncertainties including, but
not limited to: whether the data from the Company's Phase 3 clinical
trials of KPI-121 0.25% will warrant submission and filing of an NDA on
the timeline expected, or at all; whether any additional clinical trials
will be initiated or required for KPI-121 0.25% prior to submission or
filing of an NDA, or at all, and whether any such NDA will be approved;
the Company's ability to initiate and complete clinical trials on the
timeline expected, or at all; whether the results of clinical trials
will be positive and/or replicate the results from earlier clinical
development and/or preclinical studies; that post-hoc analyses are
normally given less weight by regulatory authorities than pre-specified
analyses; whether the Company's NDA for INVELTYS will be approved by its
PDUFA date, or at all; uncertainties inherent in the availability and
timing of data from ongoing clinical trials; uncertainties related to
the Company's ability to obtain regulatory approvals to conduct trials
or to market products; the Company's ability to build a sales force and
prepare for commercial launch on the timeline expected, or at all;
whether the Company's cash resources will be sufficient to fund the
Company's foreseeable and unforeseeable operating expenses and capital
expenditure requirements for the Company's expected timeline; other
matters that could affect the availability or commercial potential of
the Company's product candidates; and other important factors, any of
which could cause the Company's actual results to differ from those
contained in the forward-looking statements, discussed in the "Risk
Factors" section of the Company's most recently filed Quarterly Report
on Form 10-Q and other filings the Company makes with the Securities and
Exchange Commission. These forward-looking statements represent the
Company's views as of the date of this release and should not be relied
upon as representing the Company's views as of any date subsequent to
the date hereof. The Company does not assume any obligation to update
any forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.

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