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 the largest Pharmacy Benefit Manager in the
United States has added EYSUVIS (loteprednol etabonate ophthalmic
suspension) 0.25% as a covered brand on its commercial formularies,
effective May 1, 2022. This adds 28.5 million commercial lives to
EYSUVIS coverage, bringing total commercial coverage to 155.3
million lives, or 92% of total commercial lives.
Also today, Kala announced that Humana, one of the largest
Medicare health plans in the United States, has added EYSUVIS as a
Preferred Brand on its Medicare formularies, effective June 1,
2022. This adds approximately 7 million Medicare lives to EYSUVIS
coverage, bringing total EYSUVIS Medicare coverage to 14.1 million
lives, or approximately 30% of all Medicare lives.
“We are excited to announce this additional payer coverage,
which brings our commercial access to 92% of covered lives and
doubles our Medicare Part D coverage. This is an important step
toward our goal of securing broad commercial and Medicare access
for EYSUVIS and we expect the additional coverage will translate
into higher prescription fulfillment rates and accelerated growth,”
said Todd Bazemore, President and Chief Operating Officer of Kala
Pharmaceuticals. “Earlier this year, we secured coverage with
several large commercial and Medicare Part D plans and, together
with these additions, we have now achieved total EYSUVIS coverage
for more than 169 million lives. We continue to engage with other
commercial and Medicare Part D health plans and anticipate further
formulary additions in 2022.”
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 regarding the addition of
Commercial and Medicare coverage translating into higher
prescription fulfillment rates and accelerating EYSUVIS growth,
Kala’s anticipation with respect to additional formulary additions
in 2022, 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, 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 KPI-012 into its business, Kala’s ability to
retain and hire key personnel, the risk that disruption resulting
from the integration of KPI-012 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
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