Kala Pharmaceuticals Announces FDA Approval of INVELTYS™ for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery
– First Twice-Daily Ocular Corticosteroid Indicated for the Treatment of Post-Operative Inflammation and Pain Following Ocular Surgery –
– Kala to Host Conference Call Today at
“The FDA approval of INVELTYS is a tremendous milestone for Kala,” said
All other ocular steroids are only approved for four-times-a-day dosing. This more frequent dosing requirement can lead to issues for both doctors and patients. Corticosteroids are the foundation of therapy for post-ocular surgery care, with the key goal of controlling inflammation and pain which is caused by surgical trauma to the eye. The use of ocular steroids post-surgery is to achieve a rapid reduction of inflammation and to promote healing of the eye. Therefore, ensuring close adherence to the steroid regimen is a critical factor for physicians in the post-surgery care of the patient and eventual overall success of the procedure.
“Today's approval of INVELTYS is welcome news for the eye care community
as it provides a clear advancement in the treatment for inflammation and
pain following ocular surgery. Having access to a BID corticosteroid in
a novel nanoparticle formulation with proven safety and efficacy will
make a positive impact on the management of my post-operative patients,”
“On behalf of the Kala team, I want to thank the many patients and
clinicians who participated in our clinical trials. With this approval,
our ongoing commercialization preparations now advance to the next phase
where we plan to hire a specialty sales force that will focus on eye
care professionals in
Kala also continues to advance KPI-121 0.25% for dry eye disease. Kala has initiated a third Phase 3 clinical trial, 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. Kala believes that the changes made to the design of STRIDE 3 will improve its probability of success. The Company expects to report top-line results for STRIDE 3 in the fourth quarter of 2019. Kala also plans to submit a New Drug Application (NDA) for KPI-121 0.25% during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2,000 patients, including one Phase 2 trial and two Phase 3 efficacy and safety trials (STRIDE 1 and STRIDE 2).
INVELTYSTM 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
Conference Call Information
Kala will hold a conference call today at
About Post-Operative Inflammation and Pain
Ocular inflammation and pain are common complications following ocular surgery. According to Marketscope, in 2017 there were approximately 8 million ocular surgeries in the U.S., which is projected to grow to up to approximately 10 million in 2022. 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 other twice-daily ocular corticosteroid products currently approved in the U.S. for the treatment of post-operative inflammation and pain.
INVELTYS (loteprednol etabonate ophthalmic suspension) 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 preclinical studies, MPP technology
increased delivery of LE into ocular tissues compared to current LE
products. INVELTYS 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.
INVELTYS was approved by the
About KPI-121 0.25%
Kala is developing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease utilizing a two-week course of therapy administered four times a day. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. KPI-121 0.25% utilizes Kala's MPP technology to enhance penetration of LE into target tissue of the eye. Kala has completed one Phase 2 and two Phase 3 clinical trials of KPI-121 0.25%. Kala has initiated a third Phase 3 trial, STRIDE 3, for which topline results are expected in the fourth quarter of 2019. Kala believes that, if approved, KPI-121 0.25%'s broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to complement existing therapies, could result in a favorable profile for the management of dry eye flares and other dry eye associated conditions.
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, LE, designed for ocular applications, resulting in the recent approval of INVELTYS for the treatment of inflammation and pain following ocular surgery. Kala plans to submit a New Drug Application for KPI-121 0.25%, for the temporary relief of the signs and symptoms of dry eye disease in the second half of 2018.
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,
INVELTYS being an important addition to eye care professionals’
treatment armamentarium, the Company’s expectation to hire a specialty
sales force that will cover the majority of Eye Care professionals and
plans to launch INVELTYS in the beginning of 2019, ocular surgeries in
the U.S. growing to up to 9.4 million in 2021, the anticipated reporting
of STRIDE 3 topline results in the fourth quarter of 2019, and the
Company’s plans to file an NDA for KPI-121 0.25% with the