-- Poster presentation and promotional
activities highlighted at the American Academy of Ophthalmology
2020 Virtual Annual Meeting -- -- On-track to begin shipping
EYSUVIS to wholesalers in mid-December -- -- Wholesale Acquisition
Cost announced --
Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a biopharmaceutical
company focused on the discovery, development and commercialization
of innovative therapies for diseases of the eye, today provided an
update on its plans to launch 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.
“We continue to make significant progress on our plans to launch
EYSUVIS and establish it as the preferred, first-line prescription
therapy for dry eye disease,” said Todd Bazemore, Chief Operating
Officer of Kala Pharmaceuticals. “We have nearly completed the
hiring and onboarding of the first wave of our planned sales force
expansion ahead of the virtual launch meeting in early December. We
have also established a wholesale acquisition cost for EYSUVIS,
which will allow us to begin submitting payer contract bids to
pharmacy benefit managers (PBMs), commercial and Medicare Part D
plans. We have expanded on our educational and marketing
activities, including data presentations and promotional events at
the recent American Academy of Ophthalmology 2020 Virtual Annual
Meeting. We expect to begin shipping EYSUVIS to wholesalers in
mid-December and look forward to delivering EYSUVIS to eye care
professionals and patients by the end of the year.”
Kala continues to make significant progress in launch
preparations for EYSUVIS since its approval by the U.S. Food and
Drug Administration (FDA) on October 26, 2020. Educational
activities were initiated at the American Academy of Ophthalmology
(AAO) 2020 Virtual Meeting, held from November 13-15, 2020.
Aggregate data from four clinical trials evaluating EYSUVIS for the
treatment of dry eye disease, including three Phase 3 trials and
one Phase 2 trial, were presented in a poster presentation by
Edward Holland, M.D., Director of Cornea Services at Cincinnati Eye
Institute and Professor of Ophthalmology at the University of
Cincinnati. Promotional activities at AAO also included a virtual
booth highlighting the product’s approval and upcoming
availability, daily sponsored educational programs in the Industry
Showcase, and a sponsored webinar hosted by the AAO Foundation.
Kala has nearly completed the hiring and onboarding of an
expanded team of sales professionals who have on average more than
seven years of ophthalmic sales experience and more than 14 years
of pharmaceutical sales experience. At launch, Kala will have
approximately 90 sales professionals and it plans to grow the sales
force to approximately 125 sales representatives in 2021, pending
the status of the COVID-19 pandemic. Over 90 percent of the sales
force has eyecare experience, and more than half have experience in
dry eye disease. A virtual launch meeting is planned for early
December 2020 with promotional activities set to begin by year end.
The Company expects to begin shipping EYSUVIS to wholesalers by
mid-December.
The Wholesale Acquisition Cost (WAC or “list price”) for a 10 mL
bottle of EYSUVIS has been set at $465. The list price is not
inclusive of discounts to payers, providers, distributors and other
purchasing organizations. The out-of-pocket cost to a patient will
depend upon insurance coverage, copay, and eligibility for
participation in the patient assistance program.
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 anticipated sales of INVELTYS®, will enable it to fund its
operations into at least the third 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
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 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 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 October 2020 approval of 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
the January 2019 launch of INVELTYS® (loteprednol etabonate
ophthalmic suspension) 1% for the treatment of post-operative
inflammation and pain following ocular surgery.
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 expectation to begin shipping
EYSUVIS to wholesalers by mid-December 2020 and delivering EYSUVIS
to eye care professionals and patients by the end of the year, the
Company’s plan to grow to 125 sales representatives in 2021,
pending the status of the COVID-19 pandemic, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201116005304/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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