Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for EYSUVIS™ for Dry Eye Disease
May 26 2020 - 8:00AM
Business Wire
-- FDA Sets PDUFA Goal Date of October 30, 2020
--
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical
company focused on the discovery, development and commercialization
of innovative therapies for diseases of the eye, today announced
that the U.S. Food and Drug Administration (FDA) has accepted for
review the company’s New Drug Application (NDA) resubmission for
EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its
product candidate for the short-term treatment of the signs and
symptoms of dry eye disease. The FDA stated that the NDA
resubmission is a complete, Class 2 response to the Complete
Response Letter (CRL) issued in August 2019, and the FDA set a
Prescription Drug User Fee Act (PDUFA) goal date of October 30,
2020 for the completion of its review of the NDA.
“The FDA’s acceptance of our NDA resubmission signifies critical
progress toward our goal of delivering EYSUVIS as the first
prescription medicine for the short-term treatment of dry eye
disease,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala
Pharmaceuticals. “We are very appreciative that the Agency set a
standard Class 2 review timeline, despite the ongoing pandemic, and
we look forward to working together through their review of our NDA
submission.”
Kala resubmitted the EYSUVIS NDA in April 2020, in response to
the CRL it received from the FDA in August 2019, which indicated
that positive data from an additional clinical trial was needed to
support a resubmission of the NDA. The positive results from STRIDE
3 for both signs and symptoms of dry eye disease, along with the
positive data from the previous clinical trials of EYSUVIS, served
as the basis for Kala’s NDA resubmission package. As announced in
March 2020, STRIDE 3, a Phase 3 clinical trial of EYSUVIS, met both
of its primary symptom endpoints, demonstrating a statistically
significant improvement in ocular discomfort severity in both the
overall intent-to-treat (ITT) population and in a predefined
subgroup of ITT patients with more severe ocular discomfort at
baseline. Additionally, statistical significance was achieved in
the key secondary endpoints of conjunctival hyperemia at day 15 in
the ITT population and ocular discomfort severity at day 8 in the
ITT population. Significant results were also observed for total
corneal staining at day 15 in the ITT population. Consistent with
prior clinical experience, EYSUVIS was well-tolerated in STRIDE 3,
with adverse events and intraocular pressure increases comparable
to vehicle.
About EYSUVIS™
Kala is developing EYSUVIS (loteprednol etabonate ophthalmic
suspension) 0.25% for the short-term treatment of the signs and
symptoms of dry eye disease. 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 tissues 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 the broad mechanism of action of EYSUVIS, rapid onset of
relief of both signs and symptoms and favorable tolerability and
safety profile combine for a strong profile to treat Dry Eye
Disease. In addition, the potential for EYSUVIS to be used both as
a first line prescription medicine and complementary to existing
therapies, could result in a preferred profile for the short-term
treatment of dry eye disease, including 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%, for which a New Drug Application (NDA) is under review by
the United States Food and Drug Administration (FDA) with a target
action date under the Prescription Drug User Fee Act (PDUFA) set
for October 30, 2020.
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 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 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,” “continue” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would,” 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: the impact of extraordinary external
events, such as the current pandemic health event resulting from
the novel coronavirus (COVID-19), and their collateral
consequences, including disruption of the activities of our sales
force and the market for INVELTYS and any delay in timing of
regulatory review of the NDA for EYSUVIS; whether the Company will
be able to successfully implement its commercialization plans for
INVELTYS and 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 on the timeline expected, or at all; 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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Hannah Deresiewicz hannah.deresiewicz@sternir.com
212-362-1200
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