“Today’s advertisement represents a cogent anniversary for Kala,” said Kim Brazzell, Chief Medical Officer of Kala. “If approved, we accept EYSUVIS could become the adopted decree analysis for dry eye flares, which affect the all-inclusive majority of dry eye patients. We acknowledge the abounding patients who alternate in this trial, and we are additionally beholden to our abstraction sites and investigators.”
The STRIDE 3 balloon is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, comparing EYSUVIS to agent (placebo), anniversary dosed four times a day (QID) for two weeks in about 900 patients with dry eye disease. Subjects who accommodated antecedent screening and inclusion/exclusion acceptance abide a two-week altercation aeon with vehicle. Subjects who abide to accommodated inclusion/exclusion acceptance afterwards the altercation are randomized to accept either EYSUVIS or agent for two weeks. The STRIDE 3 balloon architecture reflects specific modifications to the admittance and exclusion acceptance of Kala’s antecedent trials of EYSUVIS, which were implemented to advance the anticipation of success. Kala expects that abstracts from the STRIDE 3 balloon will serve as the base for the resubmission of the EYSUVIS NDA to the FDA.
About Kala Pharmaceuticals, Inc.
Kala is a biopharmaceutical aggregation focused on the development and commercialization of analysis application its proprietary AMPPLIFY™ MPP Drug Delivery Technology, with an antecedent focus on the analysis of eye diseases. Kala has activated the AMPPLIFY Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), advised for ocular applications, constant in the August 2018 FDA approval of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product, EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, which is actuality advised for the acting abatement of the signs and affection of dry eye disease.
This columnist absolution contains advanced statements aural the acceptation of the Private Securities Litigation Reform Act of 1995, that absorb abundant risks and uncertainties, including statements apropos the Company’s advance artefact candidate, EYSUVIS, for the concise analysis of dry eye disease, including the Company’s acceptance that changes fabricated to the inclusion/exclusion acceptance of STRIDE 3 will advance the anticipation of success, the Aggregation targeting topline after-effects for STRIDE 3 in the aboriginal division of 2020 and resubmission of the EYSUVIS NDA to the FDA in the aboriginal bisected of 2020, and that the NDA resubmission would be accountable to a six-month analysis beneath PDUFA. All statements, added than statements of absolute facts, independent in this Columnist Release, including statements apropos the Company’s strategy, approaching operations, approaching banking position, approaching revenue, projected costs, prospects, affairs and objectives of management, are advanced statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and agnate expressions are advised to analyze advanced statements, although not all advanced statements accommodate these anecdotic words. The Aggregation may not absolutely accomplish the plans, intentions or expectations appear in its advanced statements, and you should not abode disproportionate assurance on such advanced statements. Absolute after-effects or contest could alter materially from the plans, intentions and expectations appear in the advanced statements as a aftereffect of assorted risks and uncertainties, including but not bound to: whether the Aggregation will be able to auspiciously apparatus its commercialization affairs for INVELTYS; whether the bazaar befalling for INVELTYS and EYSUVIS is constant with the Company’s expectations and bazaar research; uncertainties inherent in the availability and timing of abstracts from advancing analytic trials, and the after-effects of such trials, including STRIDE 3; whether any added analytic trials will be accomplished or appropriate for EYSUVIS above-mentioned to approval of the NDA, or at all, and whether the NDA will be approved; the Company’s adeptness assassinate on the bartering barrage of EYSUVIS, if and back approved, on the timeline expected, or at all; whether the Aggregation will be able to accomplish its projected net artefact acquirement on the timeline expected, or at all; whether the Company’s banknote assets will be acceptable to armamentarium the Company’s accountable and adventitious operating costs and basic amount requirements for the Company’s accepted timeline; added affairs that could affect the availability or bartering abeyant of INVELTYS and the Company’s artefact candidates, including EYSUVIS; and added important factors, any of which could account the Company’s absolute after-effects to alter from those independent in the advanced statements, discussed in the “Risk Factors” area of the Company’s Annual Address on Form 10-K, best afresh filed Quarterly Address on Form 10-Q and added filings the Aggregation makes with the Securities and Exchange Commission. These advanced statements represent the Company’s angle as of the date of this absolution and should not be relied aloft as apery the Company’s angle as of any date consecutive to the date hereof. The Aggregation does not accept any obligation to amend any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise, except as appropriate by law.
Investors: Hannah Deresiewicz [email protected] 212-362-1200
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