01.07.19

Kala Pharmaceuticals Announces the Launch of Inveltys

Source: Kala Pharmaceuticals

Kala Pharmaceuticals announced the launch of Inveltys (loteprednol etabonate ophthalmic suspension) 1%, the first and only twice-daily ocular corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. Kala also announced the hiring of the specialty ophthalmology sales organization. Inveltys is now in national and regional United States 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 8 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 9 years of ophthalmic sales experience and nearly 8 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, according to Kala.

“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,” Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals, said in a company news release. “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 postoperative 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, according to Kala.

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 2-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 topline results for STRIDE 3 in the fourth quarter of 2019.

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