Kala Pharmaceuticals Provides Update on Launch Plans for Eysuvis for the Treatment of Dry Eye Disease
Kala Pharmaceuticals provided an update on its plans to launch Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to 2 weeks) treatment of the signs and symptoms of dry eye disease.
“We continue to make significant progress on our plans to launch Eysuvis and establish it as the preferred, first-line prescription therapy for dry eye disease,” Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals, said in a company news release. “We have nearly completed the hiring and onboarding of the first wave of our planned sales force expansion ahead of the virtual launch meeting in early December. We have also established a wholesale acquisition cost for Eysuvis, which will allow us to begin submitting payer contract bids to pharmacy benefit managers (PBMs), commercial and Medicare Part D plans. We have expanded on our educational and marketing activities, including data presentations and promotional events at the recent American Academy of Ophthalmology 2020 Virtual Annual Meeting. We expect to begin shipping Eysuvis to wholesalers in mid-December and look forward to delivering Eysuvis to eye care professionals and patients by the end of the year.”
Kala continues to make significant progress in launch preparations for Eysuvis since its approval by the FDA on October 26, 2020. Educational activities were initiated at the American Academy of Ophthalmology (AAO) 2020 Virtual Meeting, held from November 13-15, 2020. Aggregate data from four clinical trials evaluating Eysuvis for the treatment of dry eye disease, including three phase 3 trials and one phase 2 trial, were presented in a poster presentation by Edward Holland, MD, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. Promotional activities at AAO also included a virtual booth highlighting the product’s approval and upcoming availability, daily sponsored educational programs in the Industry Showcase, and a sponsored webinar hosted by the AAO Foundation.
Kala has nearly completed the hiring and onboarding of an expanded team of sales professionals who have on average more than 7 years of ophthalmic sales experience and more than 14 years of pharmaceutical sales experience. At launch, Kala will have approximately 90 sales professionals and it plans to grow the sales force to approximately 125 sales representatives in 2021, pending the status of the COVID-19 pandemic. Over 90 percent of the sales force has eye care experience, and more than half have experience in dry eye disease. A virtual launch meeting is planned for early December 2020 with promotional activities set to begin by year end. The company expects to begin shipping Eysuvis to wholesalers by mid-December.
The Wholesale Acquisition Cost (WAC or “list price”) for a 10 mL bottle of Eysuvis has been set at $465. The list price is not inclusive of discounts to payers, providers, distributors and other purchasing organizations. The out-of-pocket cost to a patient will depend upon insurance coverage, copay, and eligibility for participation in the patient assistance program.
As of September 30, 2020, Kala had cash, cash equivalents and short-term investments of $159.1 million. Kala anticipates that its existing cash, cash equivalents and short-term investments, along with anticipated sales of Inveltys, will enable it to fund its operations into at least the third quarter of 2022. Kala expects revenue anticipated to be generated from sales of Eysuvis will provide additional cash runway.