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 the appointment of C. Daniel Myers to its
Board of Directors. Mr. Myers, who has more than 35 years of
ophthalmic pharmaceutical experience, will serve as a Class III
director, and join both the Compensation and Nominating and
Corporate Governance Committees.
“We are very pleased to welcome Dan to our Board of Directors,”
said Mark Iwicki, Chairman, President and Chief Executive Officer
of Kala Pharmaceuticals. “Dan has an extensive background in
ophthalmology and his commercial and significant corporate strategy
experience will be instrumental as we execute on our vision of
delivering new therapies for people living with ocular disease. We
look forward to his insights on our commercial products EYSUVIS®
and INVELTYS®, as well as with his guidance more broadly as we
pursue our goal of establishing Kala as a leader in the treatment
of eye diseases.”
“I am excited to support Kala in its efforts to change the
treatment paradigm for ocular diseases and am particularly
enthusiastic about the opportunity for EYSUVIS to meaningfully
improve the care of people living with dry eye disease,” said Mr.
Myers, “I look forward to collaborating with the management team
and the other members of Kala’s Board, and to offering my
perspective on strategic initiatives including the expansion of
Kala’s pipeline.”
Mr. Myers is currently the Chief Executive Officer of MediPrint
Ophthalmics, Inc. (formerly Leo Lens Pharma), a position he has
held since 2020. Prior to that he was the co-founder and Chief
Executive Officer of Alimera Sciences, where he continues to serve
as Non-Executive Chairman of the Board of Directors. Before
founding Alimera, Mr. Myers was a founding employee of Novartis
Ophthalmics (formerly CIBA Vision Ophthalmics) and served as
President from 1997 to 2003 and as Vice President of Sales and
Marketing from 1991 to 1997. He previously served on the Board of
Directors of Ocular Therapeutix, Inc. from 2009 to 2012. Mr. Myers
holds a B.S. in Industrial Management from Georgia Institute of
Technology.
In conjunction with Mr. Myers’ appointment, Kala announced that
Rajeev Shah, a member of the company’s Board of Directors since
2015, will be leaving the Board.
“We are sincerely thankful to Rajeev for his many contributions,
which have been instrumental in enabling Kala to mature from a
private, clinical-stage company into a publicly traded commercial
organization,” continued Mr. Iwicki. “Rajeev has been a great
partner and made significant contributions to Kala’s evolution. We
wish him the best in his future endeavors.”
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. 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 INVELTYS:INVELTYS (loteprednol etabonate
ophthalmic suspension) 1% is a twice-a-day corticosteroid for the
treatment of post-operative inflammation and pain following ocular
surgery. INVELTYS utilizes Kala’s proprietary AMPPLIFY
mucus-penetrating particle (MPP) Drug Delivery Technology to
enhance penetration of loteprednol etabonate (LE) into target
tissues of the eye. 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. INVELTYS was
approved by the FDA on August 22, 2018. Kala believes INVELTYS has
a favorable profile for the treatment of inflammation and pain
following ocular surgery, due to its twice-a-day dosing
regimen.
INVELTYS, 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. A prolonged use of corticosteroids may result in
glaucoma with damage to the optic nerve, defects in visual acuity
and fields of vision. If this product is used for 10 days or
longer, IOP should be monitored. Use of corticosteroids may result
in posterior subcapsular cataract formation. Use of steroids after
cataract surgery may delay healing and increase the incidence of
bleb formation. In those diseases causing thinning of the cornea or
sclera, perforations have been known to occur with the use of
topical steroids. The initial prescription and 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 suppress the host
response and thus increase the hazard of secondary ocular
infections. In acute purulent conditions, steroids 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 steroids 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 steroid application. Fungus invasion must be
considered in any persistent corneal ulceration where a steroid has
been used or is in use. In clinical trials, the most common adverse
drug reactions were eye pain (1%) and posterior capsular
opacification (1%). These reactions may have been the consequence
of the surgical procedure.
Please see full Prescribing Information at www.inveltys.com
About Kala Pharmaceuticals: 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% 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 vision of delivering new therapies for people living
with ocular disease, the Company’s pursuit of its goal of
establishing itself as a leader in the development of new therapies
to treat eye disease, and the Company’s efforts to change the
treatment paradigm for ocular diseases, particularly in dry eye
disease with EYSUVIS. 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 and increasing 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.
Investors:Jill Steierjill.steier@kalarx.com
781-810-4086
Hannah Deresiewiczhannah.deresiewicz@sternir.com212-362-1200
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