-- First and only prescription therapy approved
specifically for short-term treatment of the signs and symptoms of
dry eye disease now available in pharmacies nationwide --
-- Advancing multiple NCE development programs
targeted to address front and back of eye diseases --
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
the launch of 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. EYSUVIS is now available in
national and regional U.S. pharmaceutical distribution centers.
Patients with a prescription can access EYSUVIS through their local
retail pharmacies or through home delivery.
Kala has completed the hiring and onboarding of its expanded
ophthalmology sales force, which now consists of 91 sales
professionals calling on eyecare professionals, including
ophthalmologists and optometrists. The Company plans to expand its
sales force to approximately 125 sales representatives in 2021,
pending the status of the COVID-19 pandemic. In addition, Kala’s
payor account team is actively engaged in contract discussions with
Commercial and Medicare Part D health plans.
“We are excited to announce our second product launch in two
years, with EYSUVIS now available in the United States as the first
approved prescription therapy specifically indicated for the
short-term treatment of dry eye disease,” said Mark Iwicki,
Chairman, President and Chief Executive Officer of Kala
Pharmaceuticals. “We are looking forward to bringing this important
new therapy to the millions of dry eye disease patients who suffer
from episodic flares but did not have an FDA-approved rapid-acting,
prescription treatment option prior to EYSUVIS. As we execute
against our strategy to establish EYSUVIS as the preferred,
first-line prescription therapy for dry eye disease, we continue to
promote INVELTYS® as the first and only twice daily corticosteroid
for post-operative inflammation and pain following ocular surgery,
while also advancing Kala’s next wave of pre-clinical development
programs in our pipeline.”
Kala is progressing its pipeline of pre-clinical development
programs targeted to address front and back of the eye diseases.
These programs, all of which are new chemical entities (NCEs),
include: (1) a receptor Tyrosine Kinase Inhibitor program (rTKI),
for the treatment of retinal diseases, including wet age-related
macular degeneration (Wet AMD); (2) selective glucocorticoid
receptor modulators (SEGRMs), which are a novel class of therapies
designed to modify the downstream activity of the receptors to
exhibit the anti-inflammatory and immunomodulatory properties of
corticosteroids while potentially avoiding the typical safety
concerns of steroids; and (3) novel steroids designed to target the
ocular surface and thus have the potential to be a safer
alternative to traditional topical steroids. Kala owns all
intellectual property and worldwide rights to these pipeline
candidates.
Although the Company has not finalized its full financial
results for the fourth quarter and fiscal year ended December 31,
2020, it expects to report cash, cash equivalents and short-term
investments of approximately $153.5 million as of December 31,
2020. Preliminary cash, cash equivalents and short-term investments
include net proceeds generated from the sale of shares of Common
Stock under the Company’s “at-the-market” offering program during
the fourth quarter of 2020. Kala anticipates that its cash, cash
equivalents and short-term investments as of December 31, 2020,
along with anticipated sales of INVELTYS, will enable it to fund
its operations into at least the fourth quarter of 2022. Kala
expects revenue anticipated to be generated from sales of EYSUVIS
will provide additional cash runway.
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, EYSUVISTM (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 the Company’s plan to grow its sales force to
125 sales representatives in 2021, pending the status of the
COVID-19 pandemic; the status of insurance coverage and the
availability of reimbursements for EYSUVIS and INVELTYS for
commercial and Medicare Part D patients; the commercial potential
for EYSUVIS and INVELTYS; Kala’s plans to advance its preclinical
pipeline of programs and the potential benefits of such programs;
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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210107005162/en/
Investors: Loraine Spreen loraine.spreen@kalarx.com
857-277-4842 Hannah Deresiewicz hannah.deresiewicz@sternir.com
212-362-1200
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