Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a commercial-stage
biopharmaceutical company focused on the discovery, development and
commercialization of innovative therapies for diseases of the eye,
today announced that UnitedHealthcare, one of the largest
commercial health care plans in the United States, covering
approximately 13 million lives, has added EYSUVIS (loteprednol
etabonate ophthalmic suspension) 0.25% as a covered brand on its
commercial formularies effective March 2022. EYSUVIS now has
coverage for approximately 118 million lives, or 70% of all
commercial lives.
Also today, Kala announced that Cigna Medicare has added EYSUVIS
as a preferred brand effective February 2022, adding an additional
1.9 million Medicare lives. EYSUVIS now has Medicare preferred
coverage for select plans with Express Scripts, Prime Therapeutics
and Cigna. Total EYSUVIS Medicare coverage is now approximately 7.1
million lives, or 15% of all Medicare lives.
“Today’s announcement marks significant progress toward our goal
of expanding access to EYSUVIS for the millions of people who
suffer from dry eye disease, including dry eye flares,” said Todd
Bazemore, President and Chief Operating Officer of Kala
Pharmaceuticals. “We look forward to continuing to engage with
other commercial and Medicare Part D health plans as we execute on
our goal of providing broad market access to EYSUVIS for eye care
professionals and their patients.”
EYSUVIS became commercially available in January 2021 as the
first and only FDA-approved medicine for the short-term (up to two
weeks) treatment of the signs and symptoms of dry eye disease.
About EYSUVISEYSUVIS (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. In
preclinical studies, the AMPPLIFY Drug Delivery Technology
increased delivery of LE into target ocular tissues more than
three-fold compared to an active LE comparator by facilitating
penetration through the tear film mucins. 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 short-term treatment of dry
eye disease, including the management of dry eye flares.
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.
About Kala Pharmaceuticals, Inc.Kala is a
commercial-stage 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 (MPP) Drug Delivery Technology to two
ocular therapies, EYSUVIS® (loteprednol etabonate ophthalmic
suspension) 0.25% and INVELTYS® (loteprednol etabonate ophthalmic
suspension) 1%. Kala also has a pipeline of development programs
including a clinical-stage secretome product candidate, KPI-012,
initially targeting persistent corneal epithelial defects (PCED)
and multiple proprietary new chemical entity (NCE) preclinical
development programs targeted to address unmet medical needs,
including both front and back of the eye diseases. For more
information on Kala, please visit www.kalarx.com.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties. Any statements in this press
release about Kala’s future expectations, plans and prospects,
including but not limited to statements about Kala’s goal of
expanding access to EYSUVIS for the millions of people who suffer
from dry eye disease, including dry eye flares, providing broad
market access to EYSUVIS for eye care professionals and their
patients and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “likely,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions
constitute forward-looking statements. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: 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
Kala’s sales force and the market for EYSUVIS and INVELTYS; whether
Kala will be able to successfully implement its commercialization
plans for EYSUVIS and INVELTYS; whether the market opportunity for
EYSUVIS and INVELTYS is consistent with Kala’s expectations and
market research; Kala’s ability execute on the commercial launch of
EYSUVIS on the timeline expected, or at all, including obtaining
and increasing Commercial and Medicare Part D payor coverage;
whether Kala will be able to generate its projected net product
revenue on the timeline expected, or at all; Kala’s ability to
realize the anticipated benefits of the acquisition of Combangio,
Inc. (“Combangio”) including the possibility that the expected
benefits, synergies and growth prospects from the acquisition of
Combangio will not be realized or will not be realized within the
expected time period or at all, significant transaction costs,
unknown liabilities, the risk of litigation and/or regulatory
actions related to the acquisition of Combangio, the uncertainties
inherent in the initiation and conduct of clinical trials,
availability and timing of data from clinical trials, whether
results of early clinical trials or trials in different disease
indications will be indicative of the results of ongoing or future
trials, whether results of the Phase 1b clinical efficacy trial of
KPI-012 will be indicative of results for any future clinical
trials and studies of KPI-012, uncertainties associated with
regulatory review of clinical trials and applications for marketing
approvals, whether regulatory or commercial milestones are
achieved, Kala’s ability to successfully integrate Combangio’s
business into its business, Kala’s ability to retain and hire key
personnel, the risk that disruption resulting from the acquisition
of Combangio may adversely affect its business and business
relationships, including with employees and suppliers, the
sufficiency of cash resources and need for additional financing and
other important factors, any of which could cause the Kala’s actual
results to differ from those contained in the forward-looking
statements, discussed in the “Risk Factors” section of Kala’s
Annual Report on Form 10-K, most recently filed Quarterly Report on
Form 10-Q and other filings Kala makes with the Securities and
Exchange Commission. These forward-looking statements represent
Kala’s views as of the date of this release and should not be
relied upon as representing Kala’s views as of any date subsequent
to the date hereof. Kala 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.
Investor Contacts: Jill
Steierjill.steier@kalarx.com781-996-5252
Hannah Deresiewiczhannah.deresiewicz@sternir.com212-362-1200
KALA BIO (NASDAQ:KALA)
Historical Stock Chart
From May 2024 to Jun 2024
KALA BIO (NASDAQ:KALA)
Historical Stock Chart
From Jun 2023 to Jun 2024