Kala Pharmaceuticals Announces the Launch of INVELTYS™ and the Hiring of a Specialty Ophthalmology Sales Organization
– INVELTYS now available in local pharmacies nationwide –
– Experienced specialty ophthalmology sales organization fully hired and sales representatives and payor account team actively calling on customers –
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Kala Pharmaceutical's INVELTYS, the first and only twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery (Photo: Business Wire)
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
“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
INVELTYS was approved in
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
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
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
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
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