– STRIDE 3 Met Both Prespecified Primary
Efficacy Endpoints, Ocular Discomfort Severity in the Overall ITT
Population and in ITT Patients with More Severe Baseline Discomfort
– – STRIDE 3 Met Key Sign Endpoint of Conjunctival Hyperemia – –
Data Enables EYSUVIS NDA Resubmission in 2Q 2020 – – Potential
Approval and Launch by Year-End 2020 – – Conference Call and
Webcast Today at 8:00 a.m. ET –
Kala Pharmaceuticals, Inc. (Kala) (NASDAQ:KALA), a
biopharmaceutical company focused on the discovery, development and
commercialization of innovative therapies for diseases of the eye,
today announced positive topline results from STRIDE 3, a Phase 3
clinical trial evaluating KPI-121 0.25%, which Kala plans to
commercialize under the brand name EYSUVIS (loteprednol etabonate
ophthalmic suspension) 0.25%, for the treatment of dry eye disease.
STRIDE 3 met both of its primary efficacy endpoints, demonstrating
a statistically significant improvement in the symptom endpoint of
ocular discomfort severity (ODS) at day 15 in the overall
intent-to-treat (ITT) population (p=0.0002) and in the predefined
subgroup of ITT patients with more severe ocular discomfort at
baseline (p=0.0007). Statistical significance was also achieved in
the key secondary endpoints of conjunctival hyperemia at day 15 in
the ITT population (p<0.0001) and ODS at day 8 in the ITT
population (p=0.0282). Significant results were also observed for
total corneal staining at day 15 in the ITT population (p=0.0042).
EYSUVIS was well tolerated, with adverse events and intraocular
pressure increases comparable to vehicle. Kala plans to utilize
these data as the basis for a Class 2 resubmission of the New Drug
Application (NDA) for EYSUVIS in the second quarter of 2020, with
an expected six-month review timeline by the U.S. Food and Drug
Administration (FDA).
“These data reinforce the potential of EYSUVIS to transform the
treatment landscape for dry eye disease,” said Dr. Edward Holland,
Director of Cornea Services at Cincinnati Eye Institute and
Professor of Ophthalmology at the University of Cincinnati.
“EYSUVIS would be the first prescription dry eye product developed
specifically to address the acute treatment needs of patients with
dry eye disease, including dry eye flares that are experienced by
the vast majority of patients. If approved, I believe EYSUVIS would
become a first-line therapy for patients at all stages of dry eye
disease.”
“I’m pleased to hear the exciting news that EYSUVIS has
successfully achieved the primary and key secondary endpoints in
the STRIDE 3 clinical trial,” said Dr. Kelly Nichols, Dean of the
University of Alabama at Birmingham School of Optometry. “If
approved, EYSUVIS will address an important unmet need for dry eye
patients. Most dry eye patients do not experience continual
symptoms. I believe these patients will benefit greatly from an
effective and well-tolerated short-term treatment that can be taken
when they experience flares.”
“We are thrilled with the results of STRIDE 3, which build on
our prior clinical experience with EYSUVIS in our Phase 2, STRIDE 1
and STRIDE 2 trials,” said Mark Iwicki, Chairman, President and
Chief Executive Officer of Kala Pharmaceuticals. “We would like to
express our sincere appreciation to the investigators and nearly
3,000 patients who participated in the trials. We are now focusing
on finalizing the NDA resubmission, which is targeted for the
second quarter of 2020, and on preparing for a potential U.S.
approval and launch by the end of the year. We look forward to
delivering this important new medicine to patients.”
If approved, Kala intends to commercialize EYSUVIS in the United
States with its specialty sales force, which it plans to increase
to a total of approximately 100 to 125 sales representatives, who
will promote both EYSUVIS and INVELTYS® (loteprednol etabonate
ophthalmic suspension) 1%.
STRIDE 3 Topline Results:
STRIDE 3 was a multicenter, randomized, double-masked,
placebo-controlled, parallel-arm study, comparing EYSUVIS to
vehicle (placebo), each dosed four times a day (QID) for two weeks
in 901 patients with dry eye disease. The ITT population consisted
of 447 patients in the EYSUVIS treatment group and 454 patients
receiving vehicle. Patients who met initial screening and
inclusion/exclusion criteria then underwent a two-week run-in
period with vehicle. Patients who continued to meet
inclusion/exclusion criteria after the run-in were then randomized
to receive either EYSUVIS or vehicle for two weeks. ODS was graded
daily by the patient over the entire course of the trial using a
visual analog grading scale (measured on a scale ranging from 0 to
100 mm) recorded in a patient diary.
STRIDE 3 achieved both of its independent primary endpoints,
demonstrating a statistically significant reduction in the symptom
endpoint of ODS from baseline to day 15 compared to vehicle control
in both the overall ITT population (p=0.0002) and in a pre-defined
subgroup of ITT patients with more severe baseline ocular
discomfort (p=0.0007), defined as patients who scored greater than
or equal to 68 mm in baseline ocular discomfort. These data
replicate the achievement of both primary symptom endpoints of
STRIDE 1 (p<0.0001 in the overall ITT population and p=0.0008 in
the pre-defined ITT subgroup with more severe ocular discomfort at
baseline). Statistical significance was also achieved in the key
secondary endpoint of conjunctival hyperemia at day 15 in the ITT
population (p<0.0001). This result replicates the achievement of
the results of STRIDE 1 and STRIDE 2, where statistical
significance was demonstrated for conjunctival hyperemia at day 15
in the ITT population as a prespecified primary endpoint in each of
those trials. Statistical significance was also achieved for the
key secondary endpoint of ODS at day 8 in the ITT population
(p=0.0282), which was consistent with STRIDE 1 (p=0.0011) and
STRIDE 2 (p=0.0408). Significant improvement was also observed for
corneal staining in the ITT population (p=0.0042), consistent with
the result in STRIDE 2 (p=0.0314).
EYSUVIS was well-tolerated in this trial, consistent with prior
clinical trials. The most common adverse event observed in STRIDE 3
was instillation site pain, which was reported by 2.9% in the
EYSUVIS group compared to 1.5% in the vehicle group. Elevations in
intraocular pressure (IOP), a known side effect with topical
corticosteroid administration, were similar between the two groups,
with no patients in either the EYSUVIS or vehicle group
experiencing an increase in IOP of 5 mmHg or greater that resulted
in an IOP of greater than 21 mmHg in the study eye.
Conference Call Information:
Kala will host a live conference call and webcast today, March
9, 2020 at 8:00 a.m. ET to review the STRIDE 3 data and discuss
next steps for the EYSUVIS program. To access the conference call,
please dial 866-300-4091 (domestic callers) or 703-736-7433
(international callers) five minutes prior to the start of the call
and provide the conference ID: 4458057. To access the slides that
will be presented during the conference call, and to access a
subsequent archived recording of the call, please visit the
“Investors & Media” section on the Kala website at
http://kalarx.com.
About EYSUVIS:
Kala is developing EYSUVIS (loteprednol etabonate ophthalmic
suspension) 0.25% for the temporary relief of the signs and
symptoms of dry eye disease utilizing a two-week course of therapy.
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. EYSUVIS utilizes Kala's AMPPLIFY™
mucus-penetrating particle (MPP) Drug Delivery Technology to
enhance penetration of loteprednol etabonate (LE) into target
tissue of the eye. Kala has completed one Phase 2 and three Phase 3
clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3 (STRIDE - Short
Term Relief In Dry Eye) for EYSUVIS. Kala believes that EYSUVIS'
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 preferred profile for the management of dry eye flares and
other dry eye associated conditions.
About Kala Pharmaceuticals, Inc.:
Kala is a biopharmaceutical company focused on the discovery,
development and commercialization of innovative therapies for
diseases of the eye. Kala has applied its AMPPLIFYTM mucus
penetrating particle Drug Delivery Technology to a corticosteroid,
loteprednol etabonate (LE), designed for ocular applications,
resulting in the January 2019 launch of INVELTYS® (loteprednol
etabonate ophthalmic suspension) 1% and its investigational product
candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension)
0.25%, which is being studied 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 INVELTYS and the Company's lead product
candidate, EYSUVIS, for the temporary relief of the signs and
symptoms of dry eye disease, including the Company targeting
resubmission of its NDA to the FDA in the second quarter of 2020,
expectations regarding timing of FDA review of the NDA and
potential launch by year-end 2020, the market potential for EYSUVIS
and the Company’s plans to expand its commercial sales force. 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 Company will be able to
successfully implement its commercialization plans for EYSUVIS, if
approved; whether the market opportunity for INVELTYS and EYSUVIS
is consistent with the Company’s expectations and market research;
whether any additional clinical trials will be initiated or
required for EYSUVIS prior to approval of the NDA, or at all, and
whether the NDA for EYSUVIS will be approved; the Company’s ability
execute on the commercial launch of EYSUVIS, if and when approved,
on the timeline expected, or at all; whether the Company will be
able to generate its projected net product revenue 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 INVELTYS and the Company's
product candidates, including EYSUVIS; 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 Annual Report on
Form 10-K 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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version on businesswire.com: https://www.businesswire.com/news/home/20200309005294/en/
Investors: Hannah Deresiewicz
hannah.deresiewicz@sternir.com 212-362-1200
Media: Silvana Guerci-Lena
Silvana@pascalecommunications.com 508-808-8993
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