-- First Approved Prescription Therapy
Specifically for Short-Term Treatment of Dry Eye Disease -- --
First Ocular Corticosteroid Indicated for Dry Eye Disease -- --
Kala to Host Conference Call Today at 8:30 a.m. ET --
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 approved
EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the
short-term (up to two weeks) treatment of the signs and symptoms of
dry eye disease.
“The FDA approval of EYSUVIS as the first prescription therapy
specifically developed to address the short-term treatment needs of
people living with dry eye disease is a major accomplishment for
Kala and an important moment for patients, who have been waiting
for an FDA-approved, safe, effective and fast-acting therapy,” said
Mark Iwicki, Chairman, President and Chief Executive Officer of
Kala Pharmaceuticals. “As we prepare to launch EYSUVIS, we will
leverage our strong foundation of highly experienced ophthalmology
marketing, sales and market access professionals with the goal of
establishing EYSUVIS as the preferred, first-line prescription
therapy for dry eye disease. We’d like to thank the many patients
and investigators that were involved in the clinical trials that
led to this important milestone.”
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. Approximately 80 percent of people living
with dry eye disease suffer from episodic flares. These flares can
be caused by a wide variety of triggers and often cannot be
adequately managed with current therapies.
EYSUVIS utilizes Kala’s AMPPLIFY® mucus-penetrating particle
(MPP) Drug Delivery Technology to enhance penetration of
loteprednol etabonate (LE) into target tissue on the ocular
surface. LE targets the immune responses that drive acute dry eye
disease flares. Prior to EYSUVIS, there were no FDA-approved ocular
corticosteroids for the treatment of dry eye disease. Kala
Pharmaceuticals plans to launch EYSUVIS in the U.S. by
year-end.
“The approval of EYSUVIS ushers in a new era in the treatment of
dry eye disease and offers promise to the millions of dry eye
patients who experience acute exacerbations, or flares, of their
disease each year,” said Edward Holland, M.D., Director of Cornea
Services at Cincinnati Eye Institute and Professor of Ophthalmology
at the University of Cincinnati. “For the first time we will be
able to offer dry eye patients a therapeutic option that provides
rapid relief for both the signs and symptoms of the disease and
that is safe and well tolerated.”
“Dry eye disease can significantly decrease quality-of-life
among affected patients and drive decreased workplace productivity,
contact lens intolerance and discontinuation, and poor cataract and
refractory surgery outcomes,” said Kelly Nichols, O.D., M.P.H.,
Ph.D., F.A.A.O., Dean of the University of Alabama at Birmingham
School of Optometry. “As the prevalence of dry eye disease
increases, there is a tremendous need for new therapies to manage
mild-to-moderate dry eye disease patients, many of whom currently
go untreated. I am excited by the approval of EYSUVIS and confident
that having access to an approved corticosteroid specifically for
dry eye disease will meaningfully impact the management of patients
across the U.S.”
The FDA granted approval to EYSUVIS based on results from four
clinical trials, including three Phase 3 trials and one Phase 2
trial, that demonstrated significant improvements in both the signs
and symptoms of dry eye disease. Specifically, statistical
significance was achieved after two weeks of dosing for the sign
endpoint of conjunctival hyperemia in all three Phase 3 trials.
Statistical significance was observed in two of the three Phase 3
trials for the symptom endpoints of 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. EYSUVIS was well-tolerated across the four
trials, with adverse events and intraocular pressure increases
comparable to that observed with vehicle.
As of September 30, 2020, Kala had cash, cash equivalents and
short-term investments of $159.1 million. Kala anticipates that its
existing cash, cash equivalents and short-term investments, along
with sales of INVELTYS®, will enable it to fund its operations into
at least the third quarter of 2022, with additional cash runway
expected based on revenues from sales of EYSUVIS.
EYSUVIS™ Important Safety Information
EYSUVIS, as with other ophthalmic corticosteroids, is
contraindicated in most viral diseases of the cornea and
conjunctiva including epithelial herpes simplex keratitis
(dendritic keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular
structures.
The initial prescription and each renewal of the medication
order should be made by a physician only after examination of the
patient with the aid of magnification, such as slit lamp
biomicroscopy, and, where appropriate, fluorescein staining.
Prolonged use of corticosteroids may result in glaucoma with
damage to the optic nerve, as well as defects in visual acuity and
fields of vision. Corticosteroids should be used with caution in
the presence of glaucoma. Renewal of the medication order should be
made by a physician only after examination of the patient and
evaluation of the IOP.
Use of corticosteroids may result in posterior subcapsular
cataract formation.
Use of corticosteroids may suppress the host response and thus
increase the hazard of secondary ocular infections. In acute
purulent conditions, corticosteroids may mask infection or enhance
existing infection.
Use of a corticosteroid medication in the treatment of patients
with a history of herpes simplex requires great caution. Use of
ocular corticosteroids may prolong the course and may exacerbate
the severity of many viral infections of the eye (including herpes
simplex).
Fungal infections of the cornea are particularly prone to
develop coincidentally with long-term local corticosteroid
application. Fungus invasion must be considered in any persistent
corneal ulceration where a corticosteroid has been used or is in
use.
The most common adverse drug reaction following the use of
EYSUVIS for two weeks was instillation site pain, which was
reported in 5% of patients.
Please see full Prescribing Information at www.eysuvis.com
Conference Call Information
Kala will hold a conference call today at 8:30 a.m. ET to
discuss the approval of EYSUVIS. 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: 2835104. Additionally, a live
webcast and subsequent archived recording of the presentation will
be available under “Events” in the “Investors” section of the Kala
website at http://kalarx.com.
About EYSUVIS
EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is
approved for the short-term (up to two weeks) treatment of the
signs and symptoms of dry eye disease. EYSUVIS utilizes Kala's
AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology
to enhance penetration of loteprednol etabonate (LE) into target
tissue of the ocular surface. EYSUVIS was approved by the FDA on
October 26, 2020. 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, offer a differentiated product
profile for the management of dry eye flares. A link to the full
product label can be found at: www.eysuvis.com.
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 AMPPLIFY® 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 the October 2020 approval
of EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for
the short-term (up to two weeks) treatment of 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 goal of establishing EYSUVIS as
the preferred, first-line prescription therapy for dry eye disease;
expectations regarding potential EYSUVIS launch timing,
expectations regarding the potential demand for EYSUVIS and the
company’s expectations regarding its use of cash, cash runway and
projected revenues. 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 EYSUVIS and INVELTYS; whether
the Company will be able to successfully implement its
commercialization plans for EYSUVIS and INVELTYS; whether the
market opportunity for EYSUVIS and INVELTYS is consistent with the
Company’s expectations and market research; the Company’s ability
execute on the commercial launch of EYSUVIS 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 EYSUVIS, INVELTYS and the Company's product
candidates; 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/20201027005351/en/
Investors Hannah Deresiewicz, 212-362-1200
Hannah.Deresiewicz@sternir.com
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