Form 8-K

8-K — OCULAR THERAPEUTIX, INC

Accession: 0001104659-26-089443

Filed: 2026-08-03

Period: 2026-08-03

CIK: 0001393434

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2621618d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2621618d1_ex99-1.htm)

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8-K (Primary)

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0001393434

2026-08-03

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

August 3, 2026

OCULAR

THERAPEUTIX, INC.

(Exact Name of Registrant as Specified in its

Charter)

Delaware

001-36554

20-5560161

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

Crosby Drive, 3rd Floor

Bedford,

MA 01730

(Address of Principal Executive Offices) (Zip

Code)

Registrant’s telephone number, including area

code: (781) 357-4000

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications

pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of

each exchange on which

registered

Common

Stock, $0.0001 par value per share

OCUL

The

Nasdaq Global Market

Indicate by check mark whether

the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)

or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company,

indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised

financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02

Results of Operations and Financial Condition.

On August 3, 2026, Ocular Therapeutix, Inc.

announced its financial results for the quarter ended June 30, 2026. The full text of the press release is furnished as Exhibit 99.1

to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K,

including Exhibit 99.1 attached hereto, is furnished to comply with Item 2.02 of Form 8-K, and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject

to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as

amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits:

99.1

Press Release of Ocular Therapeutix, Inc., dated August 3, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements

of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto

duly authorized.

OCULAR THERAPEUTIX, INC.

Date: August 3, 2026

By:

/s/ Jason S. Robins

Jason S. Robins

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2621618d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Ocular Therapeutix™

Reports Second Quarter 2026 Financial Results and Business Highlights

Ocular’s

AXPAXLITM wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026

FDA Type C Meeting

Minutes Formalize SOL-1 Trial with Confirmatory Evidence as Sufficient to Support Submission of AXPAXLI NDA in wet AMD

AXPAXLI NDA submission

to be based on SOL-1 Week 52 efficacy and safety data, interim SOL-R safety data, and confirmatory evidence

Pre-NDA meeting

scheduled with FDA in Q3 2026 with the NDA submission to follow the Section 505(b)(2) pathway which could accelerate the review

timeline by up to 60 days

New Post Hoc SOL-1 analysis demonstrates up

to an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI as compared to a projected on-label aflibercept (2 mg) dosing

schedule of every 8 weeks

Commercial readiness

accelerating ahead of a potential 2027 launch

Cash balance

of $598.6 million as of June 30, 2026, with expected runway into 2028

BEDFORD, MA, August 3, 2026 (GLOBE

NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to

redefining the retina experience, today reported financial results for the second quarter ended June 30, 2026, and provided recent

business highlights focused on its NDA submission plan and further clinical development for AXPAXLI (also known as OTX-TKI). The Company

will not be hosting a second quarter 2026 conference call following its recent investor day in June. The Company plans to resume quarterly

earnings calls for its third quarter 2026 financial results.

“We continue to execute with discipline,

precision, and urgency to redefine the retina experience and make AXPAXLI available to patients as early as possible. Our June Investor

Day marked a pivotal milestone with the announcement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet AMD in the fourth

quarter of 2026,” said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. “This approach

is designed to support the fastest risk-mitigated path to NDA submission and review. Consistent with the FDA Type C meeting minutes,

the AXPAXLI NDA submission will be based on SOL-1 efficacy and safety data, interim safety data from SOL-R and supporting confirmatory

evidence, including axitinib’s established profile as a VEGFR inhibitor from more than a decade of clinical use since FDA approval

for renal cell carcinoma. By pursuing the 505(b)(2) regulatory pathway, we believe the AXPAXLI NDA submission is strongly positioned

to benefit from a review timeline up to 60 days shorter than the typical new molecular entity.”

Peter K. Kaiser, MD, Chief Development Officer of Ocular Therapeutix

added, “SOL-1 is the first and only successful superiority trial of a novel agent against an approved anti-VEGF therapy since the

class emerged two decades ago. Today, up to 40% of wet AMD patients discontinue therapy within the first year alone, largely attributable

to the treatment burden and its impact on patients and caregivers. In a new post-hoc analysis of SOL-1 data applying the SOL-R rescue

criteria of >5 ETDRS letter loss and ≥75 µm CSFT increase from baseline, we estimate a treatment burden reduction of up to

72% as compared to a projected on-label dosing regimen of aflibercept (2 mg) over 60 weeks. The robust potential of AXPAXLI to reduce

treatment burden in the real-world may improve adherence and long-term outcomes for our patients.”

Estimated Reduction in Treatment Burden Excluding Loading Doses

Mean Number of Expected

Injections Per Subject*

AXPAXLI

aflibercept (2 mg)

Injection Burden

Reduction

From Week -8 to Week 52

1.95

7.00

Estimated Reduction in Treatment Burden Including Loading Doses

Mean Number of Expected

Injections Per Subject*

AXPAXLI

aflibercept (2 mg)

Injection Burden

Reduction

From Week -8 to Week 52

3.95

9.00

56 %

*Methodology outlined below in “Recent

Achievements and Upcoming Milestones”

Recent Achievements and Upcoming

Milestones:

· New

Drug Application (NDA) submission for AXPAXLI in wet AMD planned for Q4 2026, with FDA alignment

confirmed in May 2026 Type C meeting minutes. The NDA submission will be based on

SOL-1 efficacy and safety data, an interim SOL-R safety analysis of patients who have reached

Week 52 to be conducted in the fourth quarter of 2026, and confirmatory evidence. Together

with the existing SOL-1 safety database, this interim SOL-R safety analysis will bring the

aggregate safety dataset to more than 300 patients with at least one year of AXPAXLI safety

data and in-line with FDA requirements. A pre-NDA meeting with the FDA is scheduled for the

third quarter of 2026. Ocular intends to submit the NDA under the 505(b)(2) pathway,

which could accelerate the review timeline by up to 60 days.

· Post-hoc Analysis of SOL-1 (Phase 3, wet AMD) demonstrates up to

an estimated 72% reduction in treatment burden over 60 weeks with AXPAXLI relative to a projected on-label dosing regimen of aflibercept

(2 mg) every 8 weeks. The proportion of SOL-1 patients who would have remained rescue-free under the SOL-R rescue criteria of >5

ETDRS letter loss and ≥75 µm CSFT increase from baseline was 66.5% at Week 52. Applying the observed mean rescue treatment rates

in SOL-1 to the estimated 33.5% of subjects requiring rescue under the SOL-R criteria corresponded to an average of 0.95 aflibercept (2

mg) rescues per subject for all subjects in the AXPAXLI arm through Week 52 after a single AXPAXLI injection at baseline. The total estimated

mean injection burden with AXPAXLI represents a 72% reduction counting from the first screening visit at Week -8 excluding loading doses

and a 56% reduction when loading doses are included, as compared to a projected on-label dosing regimen of aflibercept (2 mg) with no

rescues.

· SOL-R

(Phase 3, wet AMD) to be amended to maximize AXPAXLI label potential following robust SOL-1

results and confirmation from FDA that SOL-R efficacy data is not required for the AXPAXLI

NDA submission. With superiority demonstrated at Weeks 36 and 52 against a single injection

of aflibercept (2 mg) in SOL-1, Ocular now plans to evaluate a new key secondary endpoint

of superiority to aflibercept (8 mg) at Week 96 in SOL-R. Another secondary endpoint will

evaluate prevention of fibrosis and atrophy relative to aflibercept (2 mg) at Week 96. To

facilitate these evaluations, Ocular will extend the efficacy analysis and sponsor-masking

in SOL-R until the end of study at Week 96. These outcomes, if positive, have the potential

to establish AXPAXLI as a best-in-disease agent in wet AMD. Following these changes, topline

SOL-R results are now expected in the first quarter of 2028. The trial's primary endpoint,

non-inferiority of AXPAXLI to aflibercept (2 mg) at Week 56, remains unchanged.

· SOL-X

(wet AMD) enrollment continues to accelerate, with the vast majority of trial investigators

and eligible patients opting to participate in the open-label extension study. Subjects

who have completed their two-year follow-up in either the SOL-1 or SOL-R trials are eligible

to enroll in the three-year open-label extension study evaluating the long-term safety and

outcomes of AXPAXLI dosed every 24 weeks. Ocular believes sustained VEGF suppression with

AXPAXLI may reduce the incidence of fibrosis and atrophy in wet AMD, thereby improving long-term

outcomes. The first subject enrolled in SOL-X in April 2026.

· Diabetic

retinopathy program streamlined to prioritize HELIOS-3 (Phase 3, NPDR) as Ocular's potential

single registrational trial. HELIOS-3 will now evaluate AXPAXLI dosed every 12 months

(Q48W) versus sham with the trial size being reduced from 930 to 620 patients. The decision

to amend the HELIOS-3 design was based on AXPAXLI’s observed durability of up to 12

months in SOL-1, HELIOS-1 data, and market research showing physician preference for once-yearly

dosing. HELIOS-3 is designed to support a broad label in diabetic retinal disease, including

patients with diabetic macular edema (DME).

· Commercial

readiness activities, including market and payer research, advancing rapidly ahead of a potential

2027 launch of AXPAXLI, if approved. Following SOL-1's results, market research found

that approximately 80% of retina specialists surveyed would likely use a product with AXPAXLI’s

profile based on SOL-1 data alone, with more than 90% expected to adopt such a product within

its first year, if approved. Physicians cited disease control, predictable dosing interval,

and seamless fit within existing workflows as key drivers of anticipated use. Ocular's payer

team has also engaged 100% of Tier 1 Medicare Advantage and commercial payers, who have indicated

that a label demonstrating superior durability could command premium pricing.

Second Quarter Ended June 30,

2026, Financial Results:

Total cash and cash equivalents

were $598.6 million as of June 30, 2026. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®,

the Company believes that its current cash balance is sufficient to support its planned operating expenses, debt service obligations,

and capital expenditure requirements into 2028.

This cash projection factors in the

completion of the SOL-1 trial and the continued execution of the SOL-R, the SOL-X and the HELIOS-3 trials. The projection also includes

investment in pre-commercial activities and preparations for the potential FDA approval and initial launch of AXPAXLI but does not currently

include the full expenses the Company anticipates it needs to support the near-term commercialization of AXPAXLI, if approved.

Total net revenue was $13.5

million for the second quarter of 2026, flat as compared to the comparable quarter of 2025. Total net revenue includes both gross

DEXTENZA product revenue, net of discounts, rebates, and returns, which increased $0.1 million or 0.6% over Q2 2025, and collaboration

revenue, which was $0.0 million in Q2 2026 versus $0.1 million in Q2 2025.

Research and development expenses

for the second quarter of 2026 were $54.1 million versus $51.1 million for the comparable quarter in 2025, reflecting an increase in

overall clinical expenses associated with the ongoing SOL-1, SOL-R, SOL-X and HELIOS-3 clinical trials, with additional personnel and

professional services to support these clinical trials and preparations to submit the planned NDA for AXPAXLI in wet AMD.

Selling and marketing expenses

were $17.3 million for the second quarter of 2026, as compared to $13.7 million for the comparable quarter of 2025, reflecting an increase

in personnel-related costs, including stock-based compensation expense, related to the expansion of our commercial team and pre-commercial

investments to support a potential AXPAXLI launch.

General and administrative expenses

were $22.2 million for the second quarter of 2026, as compared to $14.3 million for the comparable quarter of 2025, reflecting an increase

in personnel-related costs, including stock-based compensation expense, professional fees and facility-related costs.

Net loss for the second quarter of

2026 was $(78.8) million, or a net loss of $(0.35) per share on both a basic and diluted basis, compared to a net

loss of $(67.8) million, or a net loss of $(0.39) per share on a basic and diluted basis, for the comparable quarter of

2025.

Outstanding shares as of July 31,

2026, were approximately 225.0 million.

About AXPAXLI

AXPAXLI™ (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule,

multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and diabetic retinal

disease.

About the SOL-1 Trial

The registrational Phase 3 SOL-1 trial

(NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel

group trial that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed

randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from

the trial prior to receiving Day 1 treatment.

The superiority trial has an eight-week

loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and a central subfield thickness

(CSFT) of ≤500 μm receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best corrected visual acuity

(BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with

a CSFT of ≤350 μm were then randomized to receive a single dose of AXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At

Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI (0.45 mg) or aflibercept (2 mg).

Subjects will be followed for safety until the end of Week 104.

Throughout the trial, subjects are assessed

monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 104. The clinical trial protocol requires

that, during the trial, subjects in either arm meeting the pre-specified rescue criteria, which include a BCVA loss of ≥15 ETDRS letters

from baseline or new vision-threatening macular hemorrhage, will receive a supplemental dose of aflibercept (2 mg). The protocol provides

that after the first rescue injection, rescue therapy may be provided at investigator discretion per their clinical judgement.

The primary endpoint of SOL-1 is the

proportion of subjects who maintain visual acuity, defined as a loss of <15 ETDRS letters of BCVA from baseline, at Week 36. Predefined

statistical rules were applied to adjust for treatment discontinuation or deviation as per the pre-specified statistical analysis

plan. The trial remained masked following Week 36 and subjects were evaluated for treatment durability at Week 52. The trial is being

conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

In February 2026, Ocular reported

positive SOL-1 Week 52 topline data. The superiority primary endpoint was met with 74.1% of subjects in the AXPAXLI (0.45 mg) arm maintaining

vision at Week 36, a 17.5% risk difference (p=0.0006), compared to the aflibercept (2 mg) arm. A key secondary endpoint was met with

65.9% of subjects treated with AXPAXLI (0.45 mg) maintaining vision at Week 52, a 21.1% risk difference (p<0.0001), compared to the

aflibercept (2 mg) arm.

About the SOL-R Trial

The registrational Phase 3 SOL-R trial

(NCT06495918) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (2:2:1), three-arm

trial that includes sites located in the U.S., Argentina, India, and Australia in subjects who are treatment-naïve or were

diagnosed with wet AMD in the study eye within about four months prior to enrollment. Further, to qualify for screening, a subject’s

study eye must have had a BCVA ETDRS letter score of ≥34 (~20/200). In December 2025, the trial completed the randomization of

640 subjects.

This non-inferiority trial reflects

a patient enrichment strategy over the six months prior to randomization that includes three screening doses of any anti-VEGF therapy,

excluding brolucizumab-dbll, and monitoring to exclude those subjects with early persistent fluid or significant retinal fluid fluctuations.

Subjects who continue to meet eligibility, defined as a CSFT of ≤350 μm at Week -12 and Week –8, with ≤35 μm CSFT increase

at Week -8 from the lowest CSFT at any prior visit, entered a run-in period and received two loading doses of aflibercept (2 mg) prior

to Day 1. Subjects in the first arm receive a single dose of AXPAXLI (0.45 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72. Subjects

in the second arm receive aflibercept (2 mg) on Day 1 and per label every eight weeks thereafter. Subjects in the third arm receive a

single dose of aflibercept (8 mg) at Day 1 and are re-dosed at Weeks 24, 48, and 72, aligned with the AXPAXLI treatment arm for adequate

masking. Subjects will be followed for safety until the end of Week 96. Throughout the trial, subjects are assessed monthly. Trial subjects

and designated trial personnel will remain masked through the end of Week 96. Subjects in any arm that meet pre-specified rescue criteria

will receive a supplemental dose of aflibercept (2 mg). The pre-specified rescue criteria include a >5-letter loss in visual acuity

plus a ≥75 μm increase in CSFT.

The primary endpoint of SOL-R is to

demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI and on-label aflibercept (2 mg) arms at Week 56. As

per the protocol agreed to by the FDA, the non-inferiority margin for the lower bound is -4.5 letters of mean BCVA when compared to aflibercept

(2 mg) dosed every eight weeks. In a written Type C response received in August 2024, and a subsequent written response received

in December 2024, the FDA agreed that the SOL-R repeat dosing wet AMD trial, with a primary endpoint at Week 56, should be appropriate

as an adequate and well-controlled trial in support of a potential New Drug Application and product label for wet AMD. The trial will

remain masked to the Company following the primary endpoint Week 56 time point, as key secondary endpoints will be evaluated through

Week 96.

About the SOL-X Trial

The SOL-X trial (NCT07516132) is a multi-center,

36-month open-label extension trial designed to evaluate the long-term safety, efficacy, and disease modifying potential of AXPAXLI in

wet AMD for subjects who have successfully completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trials. The

first subject enrolled in the study in April 2026.

According to the trial design, all subjects

will be given AXPAXLI every 24 weeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or Week 96 visit in SOL-R),

and again at Weeks 24, 48, 72, 96, and 120. Subjects are assessed at Week 4, Week 12, and then every 12 weeks thereafter. Additional

visits can be conducted with supplemental anti-VEGF injection administered based on investigator discretion.

The primary objectives of SOL-X are

to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression

of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized

to receive aflibercept in either SOL-1 or SOL-R.

About the HELIOS-3 Trial

The registrational Phase 3 HELIOS-3

trial (NCT07235085) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1) two-arm

superiority trial. The trial is designed to enroll approximately 620 subjects with moderately severe to severe non-proliferative diabetic

retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). The first patient was randomized in the HELIOS-3 trial in

November 2025.

Subjects in the first arm receive a

single dose of AXPAXLI at Day 1 and are re-dosed at Week 48. Subjects in the second arm receive a sham injection at Day 1 and Week 48

aligned with the AXPAXLI treatment arm for adequate masking. Throughout the trial, subjects are assessed every 4 weeks from Day 1 through

Week 56 and every other month thereafter through Week 96.

The primary endpoint of HELIOS-3 is

the ordinal diabetic retinopathy severity score (DRSS) 2-step change status at Week 56 from baseline (≥2-step improvement, ≥2-step

worsening, less than 2-step change in either direction).

About Wet AMD

Wet age-related macular degeneration

(wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14.8 million individuals globally and 1.8 million

in the United States alone. Wet AMD causes vision loss due to abnormal new blood vessel growth and hyperpermeability and associated retinal

vascularity in the macula, which is primarily stimulated by local upregulation of vascular endothelial growth factor (VEGF). Without

prompt and continuous treatment to control this exudative activity, patients develop irreversible vision loss. With proper treatment,

patients may maintain visual function for a period of time and may temporarily regain lost vision. Challenges with current therapies

include pulsatile, repeated intraocular injections, treatment-related adverse events and up to 40% patient discontinuation within one

year of initiating treatment with continued disease progression. Taken together, these factors lead to undertreatment and a lack of long-term

vision improvement for patients.

About Diabetic Retinal Disease

Diabetic retinal disease is an increasingly

prevalent global health concern, driven by the rapidly rising number of individuals diagnosed with diabetes each year.

Diabetic retinopathy (DR) is the most

common category of retinal diseases, affecting over an estimated 103 million people worldwide. DR is a progressive condition in which

retinal blood vessels are damaged following a cascade of events triggered by chronically elevated levels of blood glucose. As many as

half of all diabetic patients are expected to develop some form of DR in their lifetime. DR can progress from the non-proliferative (NPDR)

stages to the proliferative (PDR) stage characterized by the growth of abnormal new blood vessels. Fewer than 1% of the 6.4 million NPDR

patients in the U.S. receive treatment today, despite the availability of anti-VEGF therapies approved for the indication, largely due

to the burden of frequent injections.

Diabetic macular edema (DME) is also

a leading cause of vision loss in the working-age population. DME, the result of an accumulation of fluid in the macula that can afflict

patients with diabetes, can occur at any stage of DR. In patients with DME, blood vessels in the eyes leak and start to swell, which

can cause vision loss or blindness. Anti-VEGF drugs are approved to treat DME, but these treatments typically require frequent intravitreal

injections, placing a significant burden on patients and physicians alike.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is an

integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s

investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable

hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet

AMD) and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR).

Ocular’s pipeline also leverages

the ELUTYX technology in its commercial product DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular

inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis

in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost

intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular

is currently evaluating next steps for the OTX-TIC program.

Follow the Company on its website, LinkedIn,

or X.

DEXTENZA® is a registered

trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™

are trademarks of Ocular Therapeutix, Inc.

Forward-Looking Statements

This press release contains forward-looking

statements of the Company regarding its future expectations, plans, and prospects; statements regarding the development and regulatory

status of the Company’s product candidate AXPAXLI (also known as OTX-TKI), including the Company’s intention to submit a

new drug application for AXPAXLI for the treatment of wet AMD based on Week 52 efficacy and safety data from the Company’s SOL-1

Phase 3 clinical trial, Week 52 data from an interim safety analysis to be conducted in the Company’s SOL-R clinical trial, and

confirmatory evidence, and planned amendments to the clinical trial protocols of the Company’s SOL-R and HELIOS-3 clinical trials;

statements regarding the timing, design, enrollment, randomization, conduct and retention of subjects in the Company’s ongoing

and planned clinical trials for AXPAXLI, including the SOL-1, SOL-R and SOL-X clinical trials for the treatment of wet AMD and the HELIOS-3

trial for non-proliferative diabetic retinopathy; statements regarding the commercial potential of AXPAXLI, including market research

findings and potential pricing; statements regarding the timing of the availability of data from the SOL-R trial; statements regarding

the potential commercialization of AXPAXLI, including statements regarding the potential pricing and label of AXPAXLI and the timing

of a potential commercial launch of AXPAXLI, if approved; statements regarding the Company’s plans to leverage the Section 505(b)(2) pathway

and its potential to accelerate the review timeline of the Company’s planned NDA submission; statements regarding the Company’s

cash runway and the sufficiency of the Company’s cash resources; statements regarding the potential utility or adoption, if approved,

of any of the Company’s product candidates, including AXPAXLI; and other statements containing the words “anticipate”,

“believe”, “estimate”, “expect”, “intend”, “designed”, “goal”,

“may”, “might”, “plan”, “position”, “predict”, “project”, “target”,

“potential”, “will”, “would”, “could”, “should”, “continue”,

and similar expressions, all of which constitute forward-looking statements within the meaning of The Private Securities Litigation Reform

Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important

factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development

programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking

statements. Such risks and uncertainties include, among others, uncertainties regarding the initiation, design, timing, conduct and outcomes

of the Company’s ongoing clinical trials, including the Company’s SOL-1 trial, SOL-R trial, HELIOS-3 trial, and SOL-X trial;

the timing and costs involved in commercializing any product or product candidate that receives regulatory approval; the risk that the

U.S. Food and Drug Administration, or FDA, will not agree with the Company’s interpretation of the written agreements under the

Special Protocol Assessments for AXPAXLI, including for the SOL-1 trial, or of the minutes of the Company’s Type C meeting with

the FDA; uncertainty as to whether the FDA will accept a new drug application for AXPAXLI on the basis of a single pivotal clinical trial,

notwithstanding discussions the Company has had with the FDA regarding its planned NDA submission; uncertainty as to the minimum clinical

data required to demonstrate the safety of a proposed product candidate such as AXPAXLI, even if the FDA recognizes that only one pivotal

clinical trial may be required to demonstrate efficacy and accepts the Company’s NDA submission; the risk that even though the

FDA has agreed with the overall design of the SOL-1 trial, the FDA may not find that the data generated by the trial and submitted by

the Company are sufficient to demonstrate the safety and efficacy of AXPAXLI to the degree necessary to support marketing approval for

wet AMD; the risk that the FDA might not agree to the Company’s design, protocol, and statistical analysis plan of any of its clinical

trials for which the Company has not obtained a Special Protocol Assessment, including the SOL-R trial; the risk that the Company and

the FDA may not agree on, or maintain agreement with respect to, the registrational pathway for any of its product candidates, including

AXPAXLI; uncertainty as to whether the Company will be able to timely satisfy the FDA’s other requirements for regulatory approval

of AXPAXLI, including the FDA’s Chemistry, Manufacturing and Control’s requirements, even if the Company can satisfy the

FDA’s clinical requirements to demonstrate safety and efficacy; uncertainty as to whether the Company’s NDA will qualify

for, or whether the FDA will agree to review the NDA, if accepted for filing, under the 505(b)(2) pathway, notwithstanding discussions

the Company has had with the FDA regarding its planned regulatory pathway, and whether the 505(b)(2) pathway will provide any time-savings

as compared to the traditional 505(b)(1) pathway; uncertainty as to what restrictions, if any, may be imposed on the label for AXPAXLI,

if approved, pending the receipt of additional clinical data or otherwise; uncertainty as to whether the data from earlier clinical trials

will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a

different formulation than the earlier trials, whether preliminary or interim data from a clinical trial or post-hoc analyses of clinical

data will be predictive of final data from such trial, or whether data from a clinical trial assessing a product candidate for one indication

will be predictive of results in other indications; uncertainty as to the Company’s ability to retain regulatory approval of any

product or product candidate that receives regulatory approval; uncertainty as to whether data from the Company’s SOL-X trial will

demonstrate additional clinically meaningful, long-term benefits; uncertainties regarding the potential commercial advantages and/or

position of the Company’s product candidates; uncertainty regarding the implementation and impact of most-favored-nation and other

reference pricing regimes on the commercial potential of AXPAXLI, especially in markets outside the United States; availability of data

from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development

progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including

its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s

creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; and other factors discussed

in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and

Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as

of the date of this press release. The Company anticipates that subsequent events and developments may cause the Company’s views

to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically

disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These

forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date

of this press release.

Investors & Media

Ocular Therapeutix, Inc.

Bill Slattery

Vice President, Investor Relations

bslattery@ocutx.com

Ocular Therapeutix, Inc.

Consolidated

Balance Sheets

(in thousands,

except share and per share data)

(Unaudited)

June 30,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 598,641

$ 737,060

Accounts receivable, net

30,261

30,650

Inventory

3,826

3,564

Prepaid expenses and other current assets

11,699

10,855

Total current assets

644,427

782,129

Property and equipment, net

19,456

19,676

Restricted cash

1,614

Operating lease assets

5,820

4,638

Total assets

$ 671,317

$ 808,057

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 6,996

$ 4,154

Accrued expenses and other current liabilities

39,056

43,835

Operating lease liabilities

3,122

2,817

Total current liabilities

49,174

50,806

Other liabilities:

Operating lease liabilities, net of current portion

3,466

2,815

Derivative liability

10,910

13,903

Deferred revenue

14,000

Notes payable, net

72,795

71,336

Other non-current liabilities

931

887

Total liabilities

151,276

153,747

Commitments and contingencies

Stockholders’ equity:

Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2026 and December 31, 2025, respectively

—

Common stock, $0.0001 par value; 400,000,000 and 400,000,000 shares authorized and 219,589,303 and 215,927,600 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

1,844,417

1,811,311

Accumulated deficit

(1,324,398 )

(1,157,023 )

Total stockholders’ equity

520,041

654,310

Total liabilities and stockholders’ equity

$ 671,317

$ 808,057

Ocular Therapeutix, Inc.

Consolidated

Statements of Operations and Comprehensive Loss

(in thousands,

except share and per share data)

(Unaudited)

Three Months Ended

Six Months Ended

June 30,

2026

2025

2026

2025

Revenue:

Product revenue, net

$ 13,475

$ 13,395

$ 24,260

$ 24,028

Collaboration revenue

—

128

Total revenue, net

13,475

13,459

24,260

24,156

Costs and operating expenses:

Cost of product revenue

2,011

1,944

3,340

3,206

Research and development

54,138

51,081

120,351

93,938

Selling and marketing

17,276

13,729

33,853

27,877

General and administrative

22,159

14,346

42,166

30,694

Total costs and operating expenses

95,584

81,100

199,710

155,715

Loss from operations

(82,109 )

(67,641 )

(175,450 )

(131,559 )

Other income (expense):

Interest income

5,449

3,455

11,500

7,282

Interest expense

(2,792 )

(3,016 )

(5,569 )

(6,000 )

Change in fair value of derivative liabilities

689

(641 )

2,144

(1,619 )

Gain on sale of property and equipment

—

Total other income (expense), net

3,346

(173 )

8,075

(308 )

Net loss

$ (78,763 )

$ (67,814 )

$ (167,375 )

$ (131,867 )

Net loss per share, basic

$ (0.35 )

$ (0.39 )

$ (0.75 )

$ (0.77 )

Weighted average common shares outstanding, basic

224,952,428

172,594,662

224,528,253

171,004,629

Net loss per share, diluted

$ (0.35 )

$ (0.39 )

$ (0.75 )

$ (0.77 )

Weighted average common shares outstanding, diluted

224,952,428

172,594,662

224,528,253

171,004,629

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