Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for EYSUVIS™ for Dry Eye Disease
-- FDA Sets PDUFA Goal Date of
“The FDA’s acceptance of our NDA resubmission signifies critical progress toward our goal of delivering EYSUVIS as the first prescription medicine for the short-term treatment of dry eye disease,” said
Kala resubmitted the EYSUVIS NDA in
Kala is developing EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease. 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. EYSUVIS utilizes Kala's AMPPLIFY™ mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissues of the eye. Kala has completed one Phase 2 and three Phase 3 clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3 (STRIDE - Short Term Relief In Dry Eye) for EYSUVIS. Kala believes that the broad mechanism of action of EYSUVIS, rapid onset of relief of both signs and symptoms and favorable tolerability and safety profile combine for a strong profile to treat Dry Eye Disease. In addition, the potential for EYSUVIS to be used both as a first line prescription medicine and complementary to existing therapies, could result in a preferred profile for the short-term treatment of dry eye disease, including the management of dry eye flares and other dry eye associated conditions.
Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the
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 the Company's lead product candidate, EYSUVIS, for the short-term relief of the signs and symptoms of dry eye disease. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of various risks and uncertainties including, but not limited to: the impact of extraordinary external events, such as the current pandemic health event resulting from the novel coronavirus (COVID-19), and their collateral consequences, including disruption of the activities of our sales force and the market for INVELTYS and any delay in timing of regulatory review of the NDA for EYSUVIS; whether the Company will be able to successfully implement its commercialization plans for INVELTYS and EYSUVIS, if approved; whether the market opportunity for INVELTYS and EYSUVIS is consistent with the Company’s expectations and market research; whether any additional clinical trials will be initiated or required for EYSUVIS prior to approval of the NDA, or at all, and whether the NDA for EYSUVIS will be approved on the timeline expected, or at all; the Company’s ability execute on the commercial launch of EYSUVIS, if and when approved, on the timeline expected, or at all; whether the Company will be able to generate its projected net product revenue on the timeline expected, or at all; whether the Company's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company's expected timeline; other matters that could affect the availability or commercial potential of INVELTYS and the Company's product candidates, including EYSUVIS; and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings the Company makes with the