WALTHAM, Mass.--(BUSINESS WIRE)--Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY™ mucus-penetrating particle (MPP) Drug Delivery Technology, today announced the launch of INVELTYS™ (loteprednol etabonate ophthalmic suspension) 1%, the first and only twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery, and the hiring of the specialty ophthalmology sales organization. INVELTYS is now in national and regional United States (U.S.) pharmaceutical distribution centers, and patients have access to INVELTYS through their local retail pharmacies.
A highly experienced ophthalmology specialty sales force of 57 territory sales managers has been hired, trained and deployed. The territory sales managers have on average more than eight years of ophthalmic sales experience and more than 13 years of pharmaceutical sales experience. An experienced sales leadership team has also been hired, with on average over nine years of ophthalmic sales experience and nearly eight years of pharmaceutical sales leadership experience. In addition, the payor account team, which averages over 16 years of account director experience, is actively engaged in contract discussions with Commercial and Medicare Part D health plans.
“We are excited to announce the availability of INVELTYS in the U.S., the first twice-daily topical corticosteroid with proven safety and efficacy, for the treatment of inflammation and pain following ocular surgery,” said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. “We are also pleased to announce that the ophthalmic specialty sales team has begun calling on and providing samples to eye care professionals. The sales force’s extensive ophthalmic experience, combined with their product launch experience and existing relationships with the eye care community, will be important factors for the commercial success of INVELTYS. Formulary contract bids are in discussion for commercial insurance coverage in 2019 and Medicare Part D program coverage beginning in 2020. Furthermore, through the availability of a co-pay assistance program, all patients will have immediate access to INVELTYS at launch.”
INVELTYS was approved in August 2018 as the first and only twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS utilizes Kala’s proprietary AMPPLIFY Drug Delivery Technology to enhance penetration into target tissues of the eye. In preclinical studies, the AMPPLIFY technology increased delivery of loteprednol etabonate (LE) into ocular tissues more than three-fold compared to current LE products by facilitating penetration through the tear film mucins.
The AMPPLIFY technology also underpins KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy. Kala filed a New Drug Application (NDA) for KPI-121 0.25% with the FDA and has been granted a PDUFA target action date of August 15, 2019. Based upon the FDA’s recommendation, Kala also initiated an additional Phase 3 clinical trial in July 2018, STRIDE 3 (STRIDE - Short Term Relief In Dry Eye), evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The Company expects to report top-line results for STRIDE 3 in the fourth quarter of 2019.
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 into target tissues of
the eye. In preclinical studies, the AMPPLIFY Drug Delivery Technology
increased delivery of loteprednol etabonate (LE) into ocular tissues
more than three-fold compared to current LE products 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. A link to the full product label can
be found at: www.inveltys.com
INVELTYS™ Important Safety Information
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 the full prescribing information available at: www.inveltys.com
About Kala Pharmaceuticals, Inc.
Kala is a biopharmaceutical
company focused on the development and commercialization of therapeutics
using its proprietary AMPPLIFY™ mucus-penetrating particle (MPP) Drug
Delivery Technology, with an initial focus on the treatment of eye
diseases. Kala has applied the AMPPLIFY Drug Delivery Technology to a
corticosteroid, loteprednol etabonate (LE), designed for ocular
applications, resulting in recently approved INVELTYS™ for the treatment
of inflammation and pain following ocular surgery and its lead product
candidate, KPI-121 0.25%, for the temporary relief of the signs and
symptoms of dry eye disease, for which a New Drug Application (NDA) has
been filed with the United States Food and Drug Administration (FDA) and
a target action date under the Prescription Drug User Fee Act (PDUFA)
has been set for August 15, 2019.
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 INVELTYS for the treatment
of inflammation and pain following ocular surgery and the Company's lead
product candidate, KPI-121 0.25% for the temporary relief of the signs
and symptoms of dry eye disease, the potential for commercial insurance
coverage in 2019 and Medicare Part D program coverage beginning in 2020,
and the Company’s expectation to report top-line results for STRIDE 3 in
the fourth quarter of 2019. 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,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,” “could,”
“should,” “continue” 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: whether the Company will be
able to successfully implement its commercialization plans for INVELTYS;
whether the market opportunity for INVELTYS is consistent with the
Company’s expectations and market research; uncertainties inherent in
the availability and timing of data from ongoing clinical trials, and
the results of such trials, including STRIDE 3; whether any additional
clinical trials will be required prior to approval of the NDA filed for
KPI-121 0.25%, or at all, and whether any such NDA will be approved;
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
INVELTYS and the Company's product candidates, including KPI-121 0.25%;
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 and 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.
