Kala Pharmaceuticals Announces New Drug Application for INVELTYS™ (KPI-121 1%) Has Been Accepted for Review by the U.S. Food and Drug Administration
- INVELTYS expected to be the first twice-daily ocular steroid indicated for the treatment of inflammation and pain following ocular surgery, if approved -
- PDUFA target action date of
“All currently marketed steroids for the treatment of post-surgical
inflammation and pain are approved with four-times-a-day dosing,” said
Dr.
INVELTYS utilizes Kala’s proprietary Mucus Penetrating Particle (MPP) technology. MPPs are selectively-sized nanoparticles with proprietary coatings that Kala believes significantly enhance drug penetration and distribution in ocular tissues. In pre-clinical studies, MPPs increased delivery into ocular tissues more than three-fold by facilitating penetration through the tear film mucus.
The NDA submission for INVELTYS was supported by positive data from two Phase 3 clinical trials, in each of which INVELTYS administered twice-a-day to patients following cataract surgery achieved statistical significance for both primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications compared to placebo. INVELTYS was found to be well tolerated with no treatment-related serious adverse events observed during the course of either trial.
“The FDA’s acceptance of the NDA filing for INVELTYS is another
significant milestone for the company towards our mission of developing
innovative treatments for ocular conditions using our MPP technology,”
said
About Post-Operative Inflammation and Pain
Ocular inflammation and pain are common complications following ocular surgery. According to Marketscope, in 2016 there were 7.7 million ocular surgeries in the U.S., which is projected to grow to up to 9.4 million in 2021. More than half of the ocular surgeries performed in the U.S. are cataract surgeries. Tissue damage caused by ocular surgery leads to the production of prostaglandins, lipids that aid in recovery at the site of an injury, and an increase in blood flow to the affected area, both of which contribute to inflammation. The standard of care for post-operative inflammation and pain includes anti-inflammatory drugs such as corticosteroids, which improve patient comfort and accelerate recovery through disruption of the inflammatory cascade. The current four-times-a-day dosing regimen for corticosteroid treatment can be burdensome for patients as they are taking multiple eye drop products following surgery, and is believed to reduce patient compliance. There are no twice-daily ocular corticosteroid products currently approved in the U.S. for the treatment of post-operative inflammation and pain.
About INVELTYSTM (KPI-121 1%)
INVELTYS™ (KPI-121 1%) is a twice-a-day corticosteroid for the treatment
of inflammation and pain following ocular surgery. INVELTYS utilizes
Kala’s proprietary Mucus-Penetrating Particle (MPP) technology to
enhance penetration into target tissues of the eye. In pre-clinical
studies, MPP increased delivery into ocular tissues more than three-fold
by facilitating penetration through the tear film mucus. INVELTYS has
successfully completed two Phase 3 clinical trials and achieved
statistical significance for both primary efficacy endpoints in both
trials. In each of these trials, INVELTYS was well tolerated with no
treatment-related serious adverse events observed. Kala believes
INVELTYS has a favorable profile compared to the standard of care for
the treatment of inflammation and pain following ocular surgery, due to
its twice-a-day dosing regimen and rapid onset of relief. A New Drug
Application (NDA) for INVELTYS was accepted for review by the
About
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which we have submitted an NDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
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 development and regulatory status of the company's product
candidates, including INVELTYSTM (KPI-121 1%) for the
treatment of inflammation and pain following ocular surgery and KPI-121
0.25% for the temporary relief of the signs and symptoms of dry eye
disease. All statements, other than statements of historical facts,
contained in this press release, including statements regarding our
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. We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements, and you should
not place undue reliance on our 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
our NDA for INVELTYS will be approved by its PDUFA date or at all;
uncertainties inherent in the availability and timing of data from
ongoing clinical trials; expectations for regulatory approvals to
conduct trials or to market products; whether the Company’s cash
resources will be sufficient to fund the Company’s foreseeable and
unforeseeable operating expenses and capital expenditure requirements;
other matters that could affect the availability or commercial potential
of 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 our Quarterly Reports on Form 10-Q and other filings
we make with the
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Source:
Investor and Media:
MacDougall Biomedical Communications
Cammy
Duong, 781-591-3443
cduong@macbiocom.com