Kala Pharmaceuticals Announces Completion of Enrollment of STRIDE 3 Trial for EYSUVIS™ (KPI-121 0.25%) for Dry Eye Disease
January 15 2020 - 8:00AM
Business Wire
–STRIDE 3 Topline Data Targeted in First
Quarter of 2020–
Kala Pharmaceuticals, Inc. (Kala) (NASDAQ:KALA), a
biopharmaceutical company focused on the development and
commercialization of therapeutics using its proprietary AMPPLIFY™
mucus-penetrating particle (MPP) Drug Delivery Technology, today
announced that it has completed enrollment in its STRIDE 3 (STRIDE
– Short Term Relief In Dry Eye) Phase 3 clinical trial for KPI-121
0.25%, its product candidate for the short-term treatment of dry
eye disease. If approved, Kala plans to commercialize KPI-121 0.25%
under the brand name EYSUVIS™. Kala is targeting to report top-line
results from this trial during the first quarter of 2020 and
resubmission of the EYSUVIS New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) in the first half of 2020. Kala
believes this resubmission would be subject to a six-month
review.
“Today’s announcement represents a significant milestone for
Kala,” said Kim Brazzell, Chief Medical Officer of Kala. “If
approved, we believe EYSUVIS could become the preferred
prescription therapy for dry eye flares, which affect the vast
majority of dry eye patients. We thank the many patients who
participated in this trial, and we are also grateful to our study
sites and investigators.”
The STRIDE 3 trial is 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 approximately 900 patients with dry eye disease. Subjects who
meet initial screening and inclusion/exclusion criteria undergo a
two-week run-in period with vehicle. Subjects who continue to meet
inclusion/exclusion criteria after the run-in are randomized to
receive either EYSUVIS or vehicle for two weeks. The STRIDE 3 trial
design reflects specific modifications to the inclusion and
exclusion criteria of Kala’s previous trials of EYSUVIS, which were
implemented to improve the probability of success. Kala expects
that data from the STRIDE 3 trial will serve as the basis for the
resubmission of the EYSUVIS NDA to the FDA.
About Kala Pharmaceuticals, Inc.
Kala is a biopharmaceutical company focused on the development
and commercialization of therapeutics using its proprietary
AMPPLIFY™ MPP Drug Delivery Technology, with an initial focus on
the treatment of eye diseases. Kala has applied the AMPPLIFY Drug
Delivery Technology to a corticosteroid, loteprednol etabonate
(LE), designed for ocular applications, resulting in the August
2018 FDA approval of INVELTYS® (loteprednol etabonate ophthalmic
suspension) 1% and its investigational product, EYSUVIS
(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 the Company's lead product candidate, EYSUVIS,
for the short-term treatment of dry eye disease, including the
Company’s belief that changes made to the inclusion/exclusion
criteria of STRIDE 3 will improve the probability of success, the
Company targeting topline results for STRIDE 3 in the first quarter
of 2020 and resubmission of the EYSUVIS NDA to the FDA in the first
half of 2020, and that the NDA resubmission would be subject to a
six-month review under PDUFA. 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 INVELTYS; whether the market opportunity for INVELTYS and
EYSUVIS is consistent with the Company’s expectations and market
research; uncertainties inherent in the availability and timing of
data from ongoing clinical trials, and the results of such trials,
including STRIDE 3; 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 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, 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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version on businesswire.com: https://www.businesswire.com/news/home/20200115005145/en/
Investors: Hannah Deresiewicz
hannah.deresiewicz@sternir.com 212-362-1200
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