Benzinga | Jan 7, 2021 07:05AM EST

Kala Pharmaceuticals Announces EYSUVISTM for the Treatment of Dry Eye Disease Is Now Available In All Pharmacies

Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced the launch of EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS is now available in national and regional U.S. pharmaceutical distribution centers. Patients with a prescription can access EYSUVIS through their local retail pharmacies or through home delivery.

Kala has completed the hiring and onboarding of its expanded ophthalmology sales force, which now consists of 91 sales professionals calling on eyecare professionals, including ophthalmologists and optometrists. The Company plans to expand its sales force to approximately 125 sales representatives in 2021, pending the status of the COVID-19 pandemic. In addition, Kala's payor account team is actively engaged in contract discussions with Commercial and Medicare Part D health plans.

"We are excited to announce our second product launch in two years, with EYSUVIS now available in the United States as the first approved prescription therapy specifically indicated for the short-term treatment of dry eye disease," said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. "We are looking forward to bringing this important new therapy to the millions of dry eye disease patients who suffer from episodic flares but did not have an FDA-approved rapid-acting, prescription treatment option prior to EYSUVIS. As we execute against our strategy to establish EYSUVIS as the preferred, first-line prescription therapy for dry eye disease, we continue to promote INVELTYS(r) as the first and only twice daily corticosteroid for post-operative inflammation and pain following ocular surgery, while also advancing Kala's next wave of pre-clinical development programs in our pipeline."

Kala is progressing its pipeline of pre-clinical development programs targeted to address front and back of the eye diseases. These programs, all of which are new chemical entities (NCEs), include: (1) a receptor Tyrosine Kinase Inhibitor program (rTKI), for the treatment of retinal diseases, including wet age-related macular degeneration (Wet AMD); (2) selective glucocorticoid receptor modulators (SEGRMs), which are a novel class of therapies designed to modify the downstream activity of the receptors to exhibit the anti-inflammatory and immunomodulatory properties of corticosteroids while potentially avoiding the typical safety concerns of steroids; and (3) novel steroids designed to target the ocular surface and thus have the potential to be a safer alternative to traditional topical steroids. Kala owns all intellectual property and worldwide rights to these pipeline candidates.

Although the Company has not finalized its full financial results for the fourth quarter and fiscal year ended December 31, 2020, it expects to report cash, cash equivalents and short-term investments of approximately $153.5 million as of December 31, 2020. Preliminary cash, cash equivalents and short-term investments include net proceeds generated from the sale of shares of Common Stock under the Company's "at-the-market" offering program during the fourth quarter of 2020. Kala anticipates that its cash, cash equivalents and short-term investments as of December 31, 2020, along with anticipated sales of INVELTYS, will enable it to fund its operations into at least the fourth quarter of 2022. Kala expects revenue anticipated to be generated from sales of EYSUVIS will provide additional cash runway.

About EYSUVIS

EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS utilizes Kala's proprietary AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the ocular surface. EYSUVIS was approved by the FDA on October 26, 2020. Kala believes that EYSUVIS' broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, offer a differentiated product profile for the treatment of dry eye disease, including the management of dry eye flares.