Kala Pharmaceuticals Resubmits New Drug Application for EYSUVIS™ for Dry Eye Disease
May 04 2020 - 8:00AM
Business Wire
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 it has resubmitted its New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) 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. Kala believes this application will be considered a Class
2 resubmission, with a targeted six-month review timeline under the
Prescription Drug User Fee Act (PDUFA). Kala is preparing for a
potential U.S. approval and launch by the end of 2020.
Kala resubmitted the NDA in response to the complete response
letter (CRL) it received from the FDA on August 8, 2019, which
indicated that positive data from an additional clinical trial was
needed to demonstrate efficacy and 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
(p<0.0001) and ocular discomfort severity 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).
Consistent with prior clinical experience, EYSUVIS was
well-tolerated in STRIDE 3, with adverse events and intraocular
pressure increases comparable to vehicle.
“We are pleased to resubmit our NDA, marking an important step
toward our goal of delivering EYSUVIS as the first prescription
therapy specifically for the short-term treatment needs of patients
with dry eye disease,” said Kim Brazzell, Ph.D., Chief Medical
Officer of Kala Pharmaceuticals. “Our NDA submission now includes
data from four clinical trials, which together, we believe,
demonstrate that EYSUVIS was well-tolerated and provided rapid
relief for both the signs and symptoms of dry eye disease. If
approved, we look forward to delivering this important new
treatment option to the approximately 17 million diagnosed dry eye
patients in the U.S.”
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 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 short-term treatment of dry eye
disease, including the management of dry eye flares and other dry
eye associated conditions.
About Kala Pharmaceuticals:
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 Kala recently resubmitted its New Drug Application
to the FDA.
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, including the NDA being considered a Class 2 resubmission
with a targeted six-month review timeline under PDUFA, expectations
regarding approval and launch by year-end 2020, and the market
potential for EYSUVIS. 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 accepted for filing and/or 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 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/20200504005058/en/
Investors: Hannah Deresiewicz
hannah.deresiewicz@sternir.com 212-362-1200
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