Form 8-K

8-K — OCULAR THERAPEUTIX, INC

Accession: 0001104659-26-055241

Filed: 2026-05-05

Period: 2026-05-05

CIK: 0001393434

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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):

May 5, 2026

OCULAR

THERAPEUTIX, INC.

(Exact Name of Company as Specified in 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)

Company’s telephone number, including area

code: (781) 357-4000

15 Crosby Drive

Bedford,

MA 01730

(Former name or former address, if changed since last report.)

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 May 5, 2026, Ocular Therapeutix, Inc.

announced its financial results for the quarter ended March 31, 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 May 5, 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: May 5, 2026

By:

/s/ Jason S. Robins

Jason S. Robins

Interim Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2613442d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Ocular Therapeutix™ Reports First Quarter

2026 Financial Results and Business Highlights

Enrollment underway in SOL-X long-term extension

trial in wet AMD for subjects completing two-year follow-up in SOL-1 or SOL-R

Announced positive Phase 3 SOL-1 results in

February 2026, first ever successful wet AMD superiority trial comparing a novel investigative agent to an approved anti-VEGF

SOL-1 Week 52 data presentations held at Macula

Society and VBS meetings reinforce AXPAXLI’s unmatched durability and sustained disease control data in wet AMD

Commercial preparedness plans accelerated as

Ocular intends to submit AXPAXLI NDA based on SOL-1 Week 52 data, subject to ongoing formal discussions with the U.S. FDA

SOL-R Phase 3 non-inferiority trial in wet AMD

on track for topline readout in 1Q 2027

HELIOS-3 Phase 3 trial in diabetic retinopathy

ongoing

Ocular to host Investor Day on Wednesday, June 17,

2026, in New York City, including key program and regulatory updates

Cash balance of $666.7 million as of March 31,

2026, with expected runway into 2028

BEDFORD, MA, May 05, 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 first quarter ended March 31, 2026, and provided recent business highlights.

“2026 is off to a tremendous start for Ocular, driven by the

superiority demonstrated with AXPAXLI in the landmark SOL-1 Phase 3 trial in wet AMD,” said Pravin U. Dugel, MD, Executive Chairman,

President and CEO of Ocular Therapeutix. “AXPAXLI delivered highly statistically significant, consistent, and superior outcomes

with substantially fewer rescues compared to a single dose of aflibercept (2 mg) in SOL-1. The trial not only met a high bar for clinical

success, but it also defined a clear, differentiated, and compelling product profile, with data showing unmatched durability combined

with a level of sustained disease control that is exceptional. The strength of these data has generated overwhelming enthusiasm across

the retina community and reinforces our belief that AXPAXLI has the potential to fundamentally change how wet AMD is treated. We look

forward to submitting our NDA based on SOL-1 Week 52 data, subject to our ongoing formal discussions with the U.S. FDA, and are rapidly

advancing our commercial readiness efforts.”

Dr. Dugel continued, “Beyond SOL-1, the recent initiation

of enrollment in our SOL-X wet AMD extension trial marks another important milestone and underscores the exceptional execution we are

delivering across the AXPAXLI program. Along those lines, SOL-R is progressing expeditiously, with topline data on track for the first

quarter of 2027, while HELIOS-3 also remains ongoing. At our upcoming Investor Day on June 17, we look forward to providing further

updates on our ongoing trials, key regulatory updates, and our accelerated commercial plans for AXPAXLI. With a strong balance sheet and

increasing momentum across the organization, we are well positioned to advance AXPAXLI toward potential approval and to achieve our bold

mission of redefining the retina experience.”

Recent Achievements and Upcoming Milestones:

· SOL-X (wet AMD) open label extension trial enrollment initiated in April 2026.

Subjects who have completed two-year safety follow-up in either SOL-1 or SOL-R are eligible to enroll in the SOL-X trial for an additional

three years of safety follow-up. SOL-X outcomes may further expand AXPAXLI’s potential by highlighting the need to start AXPAXLI

treatment early or potentially risk worse long-term visual outcomes due to potential fibrosis and atrophy that may be seen with pulsatile

treatments. By potentially reducing the treatment burden and improving long-term outcomes, Ocular believes the data from SOL-X could support

increased treatment adherence over both the short- and long-terms, thereby expanding the market opportunity substantially.

· SOL-1 (Phase 3, wet AMD) positive results announced in February 2026

highlight AXPAXLI’s unmatched durability in wet AMD with sustained disease control. The SOL-1 superiority trial is being conducted

under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Having successfully met the primary

endpoint in SOL-1, AXPAXLI is the first ever novel investigative agent to successfully demonstrate superiority to a single dose of an

approved anti-VEGF. With a highly statistically significant primary endpoint (p=0.0006), SOL-1 has the potential to support the first

label with a superiority claim over an anti-VEGF. Brief highlights from the SOL-1 data include:

o Superior Visual Outcomes: With just a single AXPAXLI injection, 74.1% of AXPAXLI-treated subjects maintained vision (as defined

by the clinical trial protocol) at Week 36, and 65.9% maintained vision to Week 52 compared to 55.8% at Week 36 and 44.2% at Week 52 in

the aflibercept (2 mg) arm.

o Superior Anatomic Control: Post hoc analyses demonstrated that 55.9% of AXPAXLI-treated subjects maintained CSFT increase within

30 μm from baseline at Week 36, with 44.1% maintaining this level of control up to Week 52 compared to 37.8% at Week 36 and 34.9% at

Week 52 in the aflibercept (2 mg) arm.

o Well Tolerated Safety Profile: AXPAXLI was generally well-tolerated, with no observed treatment-related ocular or systemic

serious adverse events.

SOL-1 results through Week 52 were first presented at the

49th Macula Society Annual Meeting on February 27, 2026. Additional Week 52 data, including post-hoc analyses, were presented

at the 14th Annual Vit-Buckle Society (VBS) Meeting on April 11, 2026. Copies of these releases and presentations are available in

the Investors section of the Company’s website.

· AXPAXLI New Drug Application (NDA) submission for wet AMD remains on track

based on the SOL-1 Week 52 trial results, subject to ongoing formal discussions with the U.S. FDA. Ocular plans to leverage the 505(b)(2) application

pathway, which could potentially shorten the NDA review timeline for AXPAXLI by up to two months. The Company plans to provide regulatory

updates during its Investor Day on June 17, 2026.

· SOL-R (Phase 3, wet AMD) non-inferiority trial remains on track for topline

data in 1Q 2027. The SOL-R trial completed randomization of 631 subjects in December 2025, exceeding Ocular’s 555-subject

target. This non-inferiority trial complements SOL-1 with the potential to provide additional data to support the rapid adoption of AXPAXLI

into clinical practice, if approved. SOL-R incorporates a comprehensive 24-week screening and loading phase to exclude subjects with early

persistent fluid or significant retinal fluid fluctuations, thereby de-risking the randomized trial population.

· HELIOS-3 (Phase 3, NPDR) trial ongoing as Ocular plans to provide an update

on its diabetic retinopathy program at June Investor Day. HELIOS-3 is a superiority trial in subjects with moderately severe

or severe non-proliferative diabetic retinopathy (NPDR). The trial is designed to support a broad label in diabetic retinal disease by

allowing subjects with non-center-involved diabetic macular edema (non-CI-DME) to be enrolled in the trial. The Company plans to provide

a program update at its June 2026 Investor Day.

· Investor

Day to be held on Wednesday, June 17, 2026, in New York City. The event will feature

presentations from senior Company leadership and panel discussions with prominent retinal

disease Key Opinion Leaders (KOLs). Key areas of focus include regulatory updates regarding

the AXPAXLI NDA submission plan in wet AMD, and the registrational program for AXPAXLI in

diabetic retinopathy. The Company also plans to provide an update on the ongoing SOL-R and

SOL-X trials in wet AMD, and the commercialization strategy for AXPAXLI in wet AMD, if approved.

Additional event details will be provided in advance. To register for Ocular’s 2026

Investor Day, please visit the Investor section of Ocular’s website or register HERE.

First Quarter Ended March 31, 2026, Financial Results:

Total cash and cash equivalents were $666.7 million as of March 31,

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 expenses, debt service obligations, and capital expenditure requirements

into 2028. This cash projection factors in the completion of the SOL-1 trial, the expected topline data readout from the SOL-R trial,

continuation of the SOL-X wet AMD open label extension trial and the HELIOS-3, and if needed, HELIOS-2 registrational trials in NPDR,

plus investment in pre-commercial activities associated with AXPAXLI, but does not currently include the full expenses the Company anticipates

it needs to support the commercialization of AXPAXLI, if approved.

Total net revenue was $10.8 million for the first

quarter of 2026, a 0.8% increase as compared to total net revenue of $10.7 million in the comparable quarter in 2025. Total net revenue

includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product revenue,

and collaboration revenue.

Research and development expenses for the first quarter of 2026

were $66.2 million versus $42.9 million for the comparable quarter in 2025, reflecting an increase in overall clinical expenses associated

with the ongoing SOL-1, SOL-R, and HELIOS-3 Phase 3 clinical trials, and recent initiation of the SOL-X trial, with additional personnel

and professional services to support these clinical trials.

Selling and marketing expenses were $16.6 million for the first

quarter of 2026, as compared to $14.1 million for the comparable quarter of 2025, primarily reflecting an increase in personnel-related

costs, including stock-based compensation expense, related to the expansion of our commercial team and pre-commercial activities for AXPAXLI.

General and administrative expenses were $20.0 million for the

first quarter of 2026, as compared to $16.3 million for the comparable quarter of 2025, primarily due to an increase in personnel-related

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

Net loss for the first quarter of 2026 was $(88.6) million,

or a net loss of $(0.40) per share on both a basic and diluted basis, compared to a net loss of $(64.1) million, or a net

loss of $(0.38) per share on a basic and diluted basis, for the comparable quarter of 2025. The net loss in the first quarter

of 2026 includes a net gain from the change in fair value of our derivative liability of $1.5 million, which is comprised of a non-cash

gain from fair value measurement of the derivative liability associated with the Barings Credit Facility of $1.8 million, and expense

related to actual royalty fees under the Barings Credit Facility of $(0.4) million. The net loss for the first quarter of 2025 includes

a net loss from the change in the fair value of our derivative liability of $(1.0) million, which is comprised of a $(0.6) million non-cash

loss from fair value measurement of the derivative liability associated with the Barings Credit Facility, and expense related to actual

royalty fees of $(0.4) million under the Barings Credit Facility.

Outstanding shares as of May 1, 2026, were approximately

219.0 million.

Conference Call and Webcast Information:

Ocular Therapeutix will host a conference call and webcast on Tuesday,

May 5, 2026, at 8:00 AM ET to discuss recent business progress and financial results for the first quarter ended March 31,

2026. To access the call, please dial: 1-800-343-4136 (U.S.) or 1-203-518-9843 (International). The live webcast can be accessed HERE

(Conference ID: OCULAR) and the live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events

and Presentations section of the Investor Relations page. A replay of the webcast will be archived for at least 30 days.

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 includes 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

631 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 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.

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 (1:1:1), three-arm superiority trial. The

trial is designed to enroll approximately 930 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 Weeks 24, 48 and 72. Subjects in the second arm receive a single dose of AXPAXLI at Day 1 and Week 48 and sham injection

at Weeks 24 and 72. Subjects in the third arm receive sham injection at Day 1 and at Weeks 24, 48 and 72 aligned with the AXPAXLI treatment

arms 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 1.7 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 intentions to submit a new drug application for AXPAXLI based on Week 52 data from the Company’s SOL-1 Phase 3 clinical

trial of AXPAXLI for the treatment of wet AMD, subject to ongoing formal discussions with the FDA; 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 and SOL-R Phase 3 clinical trials and the SOL-X trial for the treatment of wet AMD, and the HELIOS-3 trial for non-proliferative

diabetic retinopathy; statements regarding the commercial potential of AXPAXLI; statements regarding the timing of the availability of

data from the SOL-R trial; statements regarding the future commercialization of DEXTENZA; 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; statements regarding the Company’s intentions to hold an investor

day and provide regulatory and other updates in June 2026; 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, SOL-X trial and potential HELIOS-2 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 and HELIOS-2 trial; uncertainty as to whether the FDA will accept a new drug application

for AXPAXLI on the basis of a single pivotal clinical trial; 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; 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 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 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 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)

March 31,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 666,699

$ 737,060

Accounts receivable, net

24,347

30,650

Inventory

3,737

3,564

Prepaid expenses and other current assets

11,212

10,855

Total current assets

705,995

782,129

Property and equipment, net

18,425

19,676

Restricted cash

1,614

Operating lease assets

6,495

4,638

Total assets

$ 732,529

$ 808,057

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$ 8,026

$ 4,154

Accrued expenses and other current liabilities

36,487

43,835

Operating lease liabilities

3,170

2,817

Total current liabilities

47,683

50,806

Other liabilities:

Operating lease liabilities, net of current portion

4,230

2,815

Derivative liability

12,071

13,903

Deferred revenue

14,000

Notes payable, net

72,062

71,336

Other non-current liabilities

909

887

Total liabilities

150,955

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 March 31, 2026 and December 31, 2025, respectively

—

Common stock, $0.0001 par value; 400,000,000 and 400,000,000

shares authorized and 218,896,915 and 215,927,600 shares issued and outstanding at March 31, 2026 and December 31, 2025,

respectively

Additional paid-in capital

1,827,187

1,811,311

Accumulated deficit

(1,245,635 )

(1,157,023 )

Total stockholders’ equity

581,574

654,310

Total liabilities and stockholders’

equity

$ 732,529

$ 808,057

Ocular Therapeutix, Inc.

Consolidated Statements of Operations and Comprehensive

Loss

(in thousands, except share and per share data)

(Unaudited)

Three Months Ended

March 31,

2026

2025

Revenue:

Product revenue, net

$ 10,785

$ 10,634

Collaboration revenue

—

Total revenue, net

10,785

10,698

Costs and operating expenses:

Cost of product revenue

1,329

1,262

Research and development

66,213

42,857

Selling and marketing

16,577

14,148

General and administrative

20,006

16,348

Total costs and operating expenses

104,125

74,615

Loss from operations

(93,340 )

(63,917 )

Other income (expense):

Interest income

6,050

3,826

Interest expense

(2,777 )

(2,984 )

Change in fair value of derivative liabilities

1,455

(978 )

Total other income (expense), net

4,728

(136 )

Net loss

$ (88,612 )

$ (64,053 )

Net loss per share, basic

$ (0.40 )

$ (0.38 )

Weighted average common shares outstanding, basic

224,099,410

169,396,989

Net loss per share, diluted

$ (0.40 )

$ (0.38 )

Weighted average common shares outstanding, diluted

224,099,410

169,396,989

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