Kala Pharmaceuticals Announces EYSUVIS™ Now Covered by Express Scripts
February 16 2021 - 7:00AM
Business Wire
Express Scripts coverage effective February 5,
2021
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 Express Scripts, one of the leading pharmacy benefit managers
(PBM) in the United States, has added EYSUVIS (loteprednol
etabonate ophthalmic suspension) 0.25% to its National Preferred,
Basic and High Performance Formularies, effective February 5, 2021.
EYSUVIS is the first and only prescription therapy approved
specifically for the short-term (up to two weeks) treatment of the
signs and symptoms of dry eye disease.
“The addition of EYSUVIS to Express Scripts’ formulary is a
significant milestone towards our goal of optimizing coverage and
ensuring patients and eye care professionals have access to a
rapid-acting, short-term treatment for the signs and symptoms of
dry eye disease, including dry eye flares,” said Todd Bazemore,
Chief Operating Officer of Kala Pharmaceuticals. “We are pleased
that Express Scripts is now covering EYSUVIS, and we expect to
further expand formulary coverage in the coming weeks and months so
more patients and eye care professionals can benefit from
EYSUVIS.”
EYSUVIS was approved in October 2020 and became commercially
available in the United States in January 2021. It is available
through both national and regional U.S. pharmaceutical distribution
centers, as well as local retail pharmacies or home delivery.
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
proprietary 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 treatment of dry eye
disease, including the management of dry eye flares.
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
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 (MPP) Drug Delivery Technology to two
ocular therapies, EYSUVIS™ (loteprednol etabonate ophthalmic
suspension) 0.25% for the short-term (up to two weeks) treatment of
signs and symptoms of dry eye disease and INVELTYS® (loteprednol
etabonate ophthalmic suspension) 1% for the treatment of
post-operative inflammation and pain following ocular surgery. The
Company also has a pipeline of pre-clinical 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 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 EYSUVIS and the Company’s expectation to
further expand formulary coverage in the coming weeks and months.
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 the
Company’s 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, including obtaining Commercial and Medicare
Part D payor coverage; 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 and INVELTYS; 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/20210216005214/en/
Investor Contacts: Loraine Spreen
loraine.spreen@kalarx.com 857-277-4842
Hannah Deresiewicz hannah.deresiewicz@sternir.com
212-362-1200
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