Item 8.01. Other Events.
On
March 9, 2020, Kala Pharmaceuticals, Inc. (the “Company”) announced topline results from STRIDE 3, its Phase 3
clinical trial of EYSUVIS™, the Company’s product
candidate for the short-term treatment of dry eye disease. STRIDE 3 was a multicenter, randomized, double-masked, placebo-controlled,
parallel-arm study, comparing EYSUVIS to vehicle (placebo), each dosed four times a day (“QID”) for two weeks in 901
patients with dry eye disease. The intent-to-treat (“ITT”) population consisted of 447 patients in the EYSUVIS treatment
group and 454 patients receiving vehicle. Patients who met initial screening and inclusion/exclusion criteria then underwent a
two-week run-in period with vehicle. Patients who continued to meet inclusion/exclusion criteria after the run-in were then randomized
to receive either EYSUVIS or vehicle for two weeks. Ocular discomfort severity (“ODS”) was graded daily by the patient
over the entire course of the trial using a visual analog grading scale (measured on a scale ranging from 0 to 100 mm) recorded
in a patient diary.
STRIDE 3 achieved both of its independent primary endpoints,
demonstrating a statistically significant reduction in the symptom endpoint of ODS from baseline to day 15 compared to vehicle
control in both the overall ITT population (p=0.0002) and in a pre-defined subgroup of ITT patients with more severe baseline ocular
discomfort (p=0.0007), defined as patients who scored greater than or equal to 68 mm in baseline ocular discomfort. These data
replicate the achievement of both primary symptom endpoints of STRIDE 1 (p<0.0001 in the overall ITT population and p=0.0008
in the pre-defined ITT subgroup with more severe ocular discomfort at baseline). Statistical significance was also achieved in
the key secondary endpoint of conjunctival hyperemia at day 15 in the ITT population (p<0.0001). This result replicates the
achievement of the results of STRIDE 1 and STRIDE 2, where statistical significance was demonstrated for conjunctival hyperemia
at day 15 in the ITT population as a prespecified primary endpoint in each of those trials. Statistical significance was also achieved
for the key secondary endpoint of ODS at day 8 in the ITT population (p=0.0282), which was consistent with STRIDE 1 (p=0.0011)
and STRIDE 2 (p=0.0408). Significant improvement was also observed for corneal staining in the ITT population (p=0.0042), consistent
with the result in STRIDE 2 (p=0.0314).
EYSUVIS was well-tolerated in this trial, consistent with prior
clinical trials. The most common adverse event observed in STRIDE 3 was instillation site pain, which was reported by 2.9% in the
EYSUVIS group compared to 1.5% in the vehicle group. Elevations in intraocular pressure (“IOP”), a known side effect
with topical corticosteroid administration, were similar between the two groups, with no patients in either the EYSUVIS or vehicle
group experiencing an increase in IOP of 5 mmHg or greater that resulted in an IOP of greater than 21 mmHg in the study eye.
If approved, the Company intends to commercialize EYSUVIS in
the United States with its specialty sales force, which it plans to increase to a total of approximately 100 to 125 sales representatives,
who will promote both EYSUVIS and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1%.
Forward-Looking Statements
This Current Report on Form 8-K 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 INVELTYS and the Company’s
lead product candidate, EYSUVIS, for the temporary relief of the signs and symptoms of dry eye disease, the market potential for
EYSUVIS and the Company’s plans to expand its commercial sales force. All statements, other than statements of historical
facts, contained in this Current Report on Form 8-K, 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,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “target,” “potential,”
“will,” “would,” “could,” “should,” “continue” 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: whether the Company will be able to successfully implement its commercialization plans for 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; 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 and other filings the Company makes
with the Securities and Exchange Commission. These forward-looking statements represent the Company’s views as of the date
of this Current Report on Form 8-K and should not be relied upon as representing the Company’s views as of any date subsequent
to the date hereof. The Company does not assume any obligation to update any forward-looking statements, whether as a result of
new information, future events or otherwise, except as required by law.