Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA & Plans to Respond with Data From STRIDE 3 T...
August 08 2019 - 4:01PM
Business Wire
-- Targeting Topline Data from STRIDE 3 by the
End of 2019 --
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), today announced that
it received a complete response letter (CRL) from the U.S. Food and
Drug Administration (FDA) regarding the Company’s new drug
application (NDA) for KPI-121 0.25% for the temporary relief of the
signs and symptoms of dry eye disease. The FDA indicated that
efficacy data from an additional clinical trial will be needed to
support a resubmission.
Kala continues to enroll patients in its ongoing STRIDE 3
(STRIDE – Short Term Relief In Dry Eye) Phase 3 clinical trial, and
expects this trial will serve as the basis of its response to the
CRL. Kala is targeting topline data from STRIDE 3 by the end of
2019 and resubmission of the NDA during the first half of 2020. The
Company believes this resubmission would be subject to a six-month
review under the Prescription Drug User Fee Act. Kala initiated
STRIDE 3 in July 2018 at the recommendation of the FDA. The STRIDE
3 trial design reflects specific modifications to the inclusion and
exclusion criteria of Kala’s previous trials of KPI-121 0.25%,
which were implemented to improve the probability of success.
“We remain confident in the potential of KPI-121 0.25% to be the
first approved product for the temporary relief of the signs and
symptoms of dry eye disease,” said Kim Brazzell, Chief Medical
Officer of Kala Pharmaceuticals. “We look forward to reporting data
from STRIDE 3 and resubmitting the NDA with the goal of obtaining
approval and being able to offer KPI-121 0.25% to the millions of
patients with dry eye disease.”
The STRIDE 3 trial is a multicenter, randomized, double-blind,
placebo-controlled, parallel-arm study, comparing KPI-121 0.25% 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 KPI-121 0.25% or vehicle for two weeks.
The NDA for KPI-121 0.25% included data from one Phase 2 and two
Phase 3 efficacy and safety trials, STRIDE 1 and STRIDE 2, studying
approximately 2,000 patients with 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. 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 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 two Phase 3
clinical trials, STRIDE 1 and STRIDE 2 (STRIDE - Short Term Relief
In Dry Eye), of KPI-121 0.25%. A third Phase 3 study, STRIDE 3, is
currently ongoing and Kala is targeting topline data by the end of
2019. 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 Pharmaceuticals, Inc.
Kala is a biopharmaceutical company focused on the development
and commercialization of therapeutics using its proprietary
AMPPLIFY™ mucus-penetrating particle (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® for the treatment of inflammation and pain following
ocular surgery and its lead product candidate, 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 lead product candidate, KPI-121
0.25% for the temporary relief of the signs and symptoms 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’s belief that resubmission of
the NDA would be subject to a six-month review under the
Prescription Drug User Fee Act, and the Company targeting to report
topline results for STRIDE 3 by the end of 2019 and resubmission of
the NDA during the first half of 2020. 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 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
KPI-121 0.25% 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 INVELTYS 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 KPI-121 0.25%; 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/20190808005767/en/
Investors Hannah Deresiewicz, 212-362-1200
hannah.deresiewicz@sternir.com
Media Amanda Houlihan, 781-235-3060
ahoulihan@macbiocom.com
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