Form 8-K

8-K — Ocugen, Inc.

Accession: 0001104659-26-115970

Filed: 2026-10-15

Period: 2026-10-15

CIK: 0001372299

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2627592d2_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2627592d2_ex99-1.htm)

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8-K — FORM 8-K

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Filename: tm2627592d2_8k.htm · Sequence: 1

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0001372299

2026-10-15

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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):

October 15, 2026

OCUGEN, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

001-36751

04-3522315

(State or Other Jurisdiction of

Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

11 Great Valley Parkway

Malvern, Pennsylvania 19355

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including

area code (484) 328-4701

N/A

(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, $0.01 par value per share

OCGN

The Nasdaq Stock Market LLC

(The Nasdaq Capital 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 7.01

Regulation FD Disclosure.

Attached as Exhibit 99.1 and incorporated herein

by reference is a presentation that Ocugen, Inc. (the “Company” or “Ocugen”) will post on its website on October

15, 2026 and may use from time to time in presentations or discussions with investors, analysts, and other parties.

The information disclosed under Item 7.01 of this

Current Report on Form 8-K (the “Report”), including Exhibit 99.1, is being furnished 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, and shall not be deemed to be incorporated by reference in any Company filing under the Securities Act

of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit

No.

Document

99.1

Ocugen, Inc. Presentation, October 2026.

104

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

SIGNATURE

Pursuant to the requirements of the Securities

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

authorized.

Date: October 15, 2026

OCUGEN, INC.

By:

/s/ Shankar Musunuri

Name: Shankar Musunuri

Title: Chairman, Chief Executive Officer, & Co-Founder

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2627592d2_ex99-1.htm · Sequence: 2

Exhibit 99.1

Courageous Innovation

Dedicated to Bringing Game-Changing Gene

Therapies to Market and Working Even Harder to

Provide Access to Patients Globally

This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995,

including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the

preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and potential

safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the

ability to initiate new clinical programs, statements regarding qualitative assessments of available data, potential benefits, expectations

for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and

uncertainties.

We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,”

“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or

outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and

uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the

risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that

unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that

earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that

clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities.

These and other risks and uncertainties are more fully described in our filings with the Securities and Exchange Commission (SEC),

including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC.

Any forward-looking statements that we make in this presentation speak only as of the date of this presentation.

Except as required by law, we assume no obligation to update forward-looking statements contained in this presentation whether as a

result of new information, future events, or otherwise, after the date of this presentation.

Forward Looking Statement

Ocugen – October 2026

Pioneering biotechnology company

leading the way to address major

blindness diseases with novel modifier

gene therapy

Leader in Ophthalmology

Gene Therapy

Targeting Three Biologics License Applications (BLAs) by 2028

Pipeline

Phase I Phase II Phase III Target BLA/ MAA*

Submission Program

ABCA4-associated

retinopathies caused by

1,200+ mutations

Phase 2/3 Pivotal ConfirmatoryClinical Trial in Progress

Mid 2027

100,000

(U.S. + EU)

Stargardt

Disease

OCU410ST

Designation: ODD, RPDD5

& OMPD

1 Regenerative Medicine Advanced Therapy (RMAT); 2 Orphan Drug Designation (ODD); 3 Orphan Medicinal Product Designation (OMPD); 4 Advance Therapy Medicinal Products (ATMP); 5 Rare Paediatric Disease Designation (RPDD);

* Market Authorization Application will follow BLA submission

Phase 2/3 Enrollment Completed

Ocugen – October 2026

Advanced dry

age-related macular

degeneration (dAMD)

Phase 3 initiated 3Q 2026

2028

2-3 million

(U.S. + EU)

Geographic

Atrophy

OCU410

Designation: RMAT,

ATMP

300,000

(U.S. + EU)

Gene-agnostic targeting

>100 genes, broad

indication

Phase 3 in Progress (Largest Orphan Gene Therapy Clinical Trial)

2Q 2027

Retinitis

Pigmentosa

OCU400

Designations: RMAT1

, ODD2

OMPD3 & ATMP4

Phase 3 Enrollment Completed

Phase 3 Pivotal ConfirmatoryClinical Trial in Progress

Breakthrough technology designed to address many rare

diseases as well as complex diseases that affect millions

Modifier Gene Therapy Platform

Traditional therapy has limited therapeutic potential

Traditional therapy can only target

one single gene at a time, limiting

therapeutic potential.

Problem

of all human proteins are

expressed in the retina

genes are highly specialized

to it, interacting through

complex pathways

mutations affecting the

retina

have already been identified

65%

785

250+

Photoreceptor development

Inflammation and cell survival

Phototransduction

Cone cell development

Metabolism

Ocugen – October 2026

The Solution is a Gene-Agnostic Approach

Solution

Our breakthrough technology is

designed to address rare diseases

and complex diseases

Targeting

master

regulators

Master regulators control entire

gene networks. By targeting them,

Ocugen’s gene therapy platform

addresses the root cause of IRDs

and multifactorial diseases (e.g.

dAMD).

Gene-Agnostic

Multifactorial

Durable Effect

Broad Impact

Ocugen – October 2026

OCU400

Retinitis Pigmentosa (RP)

Broad indication, gene-agnostic, targets 100+ genes

OCU400

First-in-Class Gene Therapy for

Retinitis Pigmentosa

Retinitis Pigmentosa (RP) is a group of rare, inherited retinal diseases

caused by mutations in over 100 genes, leading to progressive vision

loss and, in many cases, blindness.

1.6 million

2,000

Market Potential

U.S. + EU

globally suffer from RP approved treatment available

$52M peak annual sales

Luxturna® only

addresses

one gene (RPE65)

Regulatory

Milestones

(Anticipated)

One product for all 100 genes

delivered via a single,

subretinal injection

Designations

OCU400

Phase 3 trial underway —

largest orphan gene

therapy trial for RP

Enrollment completed;

Manufacturing process

validation completed;

Launch supplies ready

Topline Clinical Readout followed by

U.S. (BLA) and EU (MAA)

FDA

(RMAT + ODD)

EMA

(ATMP+ OMPD)

Patients going

untreated

298,000

Regenerative Medicine Advanced Therapy (RMAT); Orphan Drug Designation (ODD); Orphan Medicinal Product Designation (OMPD); EAP= Expanded Access Program

2026

Ocugen – October 2026

2027

The largest orphan gene therapy trial ever run, targeting

approval across all RP mutations

140

patients enrolled in

Phase 3 liMeliGhT trial

(largest orphan gene therapy Ph3)

100+

RP-causing genes

addressed by a single

subretinal injection

1H 2027

topline data expected: 1Q

BLA filing target: 2Q

POPULATION

Clinical trial eligibility criteria includes early-to late-stage RP,

spanning pediatric to adult populations

PRIMARY ENDPOINT

12-month change in visual function via LDNA Lux Level

RANDOMIZATION

2:1 — treatment vs. untreated control

EU BLA PATHWAY

Single U.S. trial accepted by EMA for MAA

Trial Design:

Enrolling patients across multiple mutations, spanning pediatric to adult populations and early-to late-stage disease. No competitor has pursued

this breadth within a single trial.

GLOBAL VALIDATION SIGNAL

Kwangdong OCU400 deal — Potential sales milestones of up to $180M+ and royalties equaling 25% of net sales

Roots Pharmaceutical OCU400 deal – Potential sales milestones up to $255 million and royalties equaling 22% of net sales

OCU400

Ocugen – October 2026

Phase 1/2 Subject Disposition: Safety and Post-hoc Efficacy Analysis

Safety analysis

All Phase 1/2 subjects

−2

→

Post-hoc efficacy

9 RHO

3 AD-NR2E3

4 AR-NR2E3

−3

→

Post-hoc efficacy

9 RHO

4 AR-NR2E3

−6

→

Phase 3 ITT*

Post hoc efficacy

5 RHO

2 AR-NR2E3

18 → 16

2 with surgery-related AEs

Sub#6, Sub#14

Safety analysis only

16 → 13

3 AD-NR2E3 subjects

Not included in the efficacy analysis due to a

dominant negative effect

13 → 7

6 excluded post-hoc

1 sentinel, poor visual acuity: Sub#1

5 subjects ceiling effect at baseline: Sub#7,

Sub#10, Sub#12, Sub#15, Sub#18

*Post-hoc analysis: Patients who qualify for Phase 3 Intent-to-Treat (ITT) criteria: RHO + AR-NR2E3 subjects, excluding adverse event, sentinel and ceiling effect subjects.

Ceiling effect on Mobility Test: Baseline performance at 1 Lux - Subjects already achieved the lowest illumination level measurable by the mobility test

AD, autosomal dominant; AR, autosomal recessive; ITT, intent to treat; MLMT, multi-luminance mobility test; Sub#= Subject number

Study Design

OCU400

Ocugen – October 2026

Phase 1/2 Population Meeting “Intent to Treat Population” Criteria for Phase 3* at 12M

*RHO +AR-NR2E3 Subjects (- Adverse Events, Sentinel); and Ceiling Effect (RHO+AR-NR2E3) Subjects, Sub#= Subject numbers

# AR-NR2E3 Subjects: Baseline MLMT at 5 Lux level; 1 Lux level improvement resulted in ceiling effect on old scale on 0-6 Lux levels

Sub#2 (RHO) Sub#8 (RHO) Sub#9 (RHO) Sub#3 (AR-NR2E3) Sub#5 (AR-NR2E3) Sub#11 (RHO) Sub#13 (RHO)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

5.0

Improvement in Lux Level

MLMT Scale LDNA Scale

Subject ID (with Mutation)

9 m 12 m

12 m

# 12 m

12 m

12 m 12 m

• Phase 3 primary endpoint revised: LDNA replaces Multi-Luminance

Mobility Test (MLMT) mobility test

• Wider range, finer resolution: 0.4–500 lux across 10 levels vs 1–400 lux

across 6 levels for MLMT

• Evenly spaced log-unit steps between lux levels and lux intensity

• Addresses the ceiling effect seen in Phase 1/2

• Clinical success: ≥2 lux level improvement from baseline at Week 52

• Why LDNA?

• Measures functional vision

• Regulatory precedent: ≥2 lux level MLMT improvement (Luxturna®)

• Correlates with visual function (e.g., LLVA) and quality of life

71.4% (5/7) of treated eyes are projected to meet ≥2 Lux

level improvement on LDNA scale

OCU400 Safety

Ocugen – October 2026

OCU400

Durable LLVA Treatment Effect Through 3 Years

7.0 6.2 8.9

Year 1 Year 2 Year 3

Δ LLVA, treated − untreated (letters)

Multiple mutations

Treated − untreated (mean ±SEM)

Clinically meaningful (5 letters)

6.5 7.3 7.6

Year 1 Year 2 Year 3

Δ LLVA, treated − untreated (letters)

RHO subgroup

Treated − untreated (mean ±SEM)

Clinically meaningful (5 letters)

88%

of evaluable treated subjects showed

improvement or preservation of LLVA

vs untreated eyes at Year 3 (7/8)

SAEs related to OCU400 through 3

years

Benefit in RHO subjects supports a

gene-agnostic mechanism of action

Evaluable, consented subjects (multiple mutations): Year 1: N = 11, Year 2: N = 11, Year 3: N = 8. Preservation = ±4 letters; improvement = ≥5 letters from baseline.

Evaluable, consented subjects for RHO mutations at Year 1 (N=10), Year 2 (N=8), Year 3 (N=5). Year 3 values are LogMAR-derived ETDRS letter equivalents. Error bars = SEM.

Ocugen – October 2026

OCU400

Phase 3 Study: >99% power as per current enrollment and effect size assumption

Statistical Method

• Power calculated using SAS PROC POWER.

• One-sided Fisher's Exact Test.

• Significance level (α): 0.025.

• Binary responder endpoint.

Study Design

• Total sample size: N = 140 subjects.(TRT-92, CTRL-48)

• Randomization ratio: 2:1 (Treatment : Control).

• Power estimated for each treatment-control responder rate

combination.

>93% power is maintained @ 20% responder rate in treatment vs 1% in control

Scenario Treatment Group

(Responder %)

Control Group

(Responder %)

Treatment Effect

(Delta)

Statistical Power

Scenario 1 50.0% (0.50) 10.0% (0.10) +40.0% 99.8%

Scenario 2 20.0% (0.20) 1.0% (0.01) +19.0% 93.2%

Treatment vs. Control Responder Proportions

Comparative power analysis across primary endpoint response scenarios

Ocugen – October 2026

OCU400

Conclusions

OCU400 was generally safe and well tolerated across doses and mutations through 3 years, with no SAEs

related to OCU400; visual acuity SAEs were attributed to surgery (foveal detachment).

Month 12 (N = 18) 89% (16/18) of subjects showed preservation or improvement in the treated eye on BCVA, LLVA, or MLMT;

LLVA and MLMT were stable or improved in 81% (13/16) of treated eyes.

Year 3 (N = 8) Durable LLVA treatment effect (mean +8.9 letters vs untreated eyes); 88% of evaluable subjects improved or

preserved.

Mechanism Benefit in RHO subjects supports the gene-agnostic modifier mechanism; evaluation continues in the Phase 3

liMeLiGhT trial.

Safety

Ocugen – October 2026

Highlights:

• Bahamas Regulatory Agency, (LARTA1

), provided provisional approval

and priority designation of OCU400

• Full LARTA approval, focused on logistics – site readiness and

activation, and patient dosing expected within 90 days under a

regulated EAP2

• The EAP is open to patients around the world at commercial pricing

• First approval of OCU400 for a broad RP indication: early-to late-stage

disease and pediatric to adult patient population

• Enables global patient access for those with high unmet medical needs

ahead of full product approval in major markets, offering an important

treatment option for patients at risk of serious vision loss and blindness

• Ocugen to generate revenue from EAP – potentially $1-2M per patient3

EAP Program in the Bahamas marks first OCU400 approval

: LARTA – Bahamas Regulatory Agency (Longevity and Regenerative Therapies Board)

: Early Access Program

: Retina “Modeling Natural History and Cost-Effectiveness of Gene-Agnostic Treatment in Retinitis Pigmentosa” (link here)

OCU400

Ocugen – October 2026

OCU410ST

Stargardt Disease

ABCA4 -associated retinopathies >1,200 mutations

OCU410ST

First-in-Class Gene Therapy for

Stargardt Disease

A rare IRD associated with 1,200+

mutations of the ABCA4 gene

1 million 0

Market Potential

U.S. + EU

globally suffer from ABCA4- approved treatments available

associated retinopathies

Regulatory

Milestones

(Completed/anticipated)

for upregulation of networks

of key genes improving the cell

environment and survival with

a single, subretinal injection

Designations

OCU410ST

2025

Initiated pivotal Phase 2/3

2027

Topline Data;

BLA submission

FDA

(RPDD+ ODD)

EMA

(ATMP + OMPD)

100%

of Patients going untreated

100,000

Potential Patients

2026

Enrollment completed

†

18 Ocugen – October 2026

† After completing a pre-specified interim analysis of atrophic lesion size in the Phase 2/3 clinical trial of OCU410ST in Stargardt disease, the independent Data Monitoring Committee (DMC)

recommended continuing the study according to the protocol except with a modification to obtain 8 months of follow-up on lesion size in the entire study population.

Phase 1 GARDian1 Trial Demonstrated Clinically Meaningful Benefit

OCU410ST

Lesion Size Reduction

54%

treated vs. Control

ImprovementorPreservationinevaluable TreatedEyes

Preservation = -/+4 letters from Baseline, Improvement: ≥5 Letters from Baseline NoSeriousAdverseEventsReported

N=6

*Khanani et al., Nature Eye, January 10, 2026 (https://doi.org/10.1038/s41433-025-04202-5 )

EZ Preservation

116%

Treated vs. Control

M12

-2

-1

EZ area loss (mm

) Mean (±SEM) change from BL

Treated Eye Untreated Fellow Eye

Treated Eyes

UntreatedEyes

Ocugen – October 2026

Phase 1 GARDian1 Trial Demonstrated Clinically Meaningful Benefit

Ocugen – October 2026

OCU410ST

Treated Eyes

UntreatedEyes

Visual Function*

100%

StabilizedorImproved

compared to untreated eyes

Nearly

1-line gain

In visual acuity compared to

untreated eyes

Improvement1

from Baseline

Decreasefrom

Baseline

Stabilization

N=6

*Khanani et al., Nature Eye, January 10, 2026 (https://doi.org/10.1038/s41433-025-04202-5 )

Improvement: > 5 ETDRS letters; Stabilization : ±4 ETDRS letters

Data points for M6 (N=6); M12 (N=6); *Nearly 6 Letters (Early Treatment Diabetic Retinopathy scale)

Two patients with worsening cataract (1 Low, 1 Med), 1 High dose patient with loss-to-follow up were not included in the analysis

GARDian3- Phase 2/3 Pivotal Confirmatory Trial

OCU410ST

Trial Design Endpoints

Randomized 2:1(N=51)

DSMB

4-week Data Reviews

Functional

improvementinvision

vs. control eye

Assessed by LLVAand

BCVA

EZ analysis

(exploratory)

TargetPopulation

Early- to late-stage disease population

Including pediatrics (3+ years)

12-month change in

atrophic lesion size

from baseline vs.

control

Measured in mm2

by fundus

autofluorescence (FAF)

Treatment Group

3×1010 vg per eye in 200 µL

ControlGroup

No Treatment First Second

17 17

All

Subjects

MTD

Established in

Phase 1

Primary Secondary

Ocugen – October 2026

OCU410

Geographic Atrophy

Advanced dry age-related macular degeneration (dAMD)

OCU410

First-in-Class Gene Therapy for

GA Patients

Geographic Atrophy

Geographic Atrophy (GA) is an advanced form of dry AMD. GA causes

irreversible degeneration of retina cells in the macula, leading to loss of

central vision.

~8 million 2

Market Size

U.S. + EU

approved treatments available that

address only 1 of the 4 pathways involved

in disease progression

globally suffer from

advanced dAMD

Regulatory

Milestones

(Anticipated)

Designed to address all

four pathways associated

with GA without 6-12

injections per year and

related side effects

Designations

OCU410

3Q 2026

Initiated Phase 3

2028

Phase 3 topline data;

BLA submission

EMA (ATMP)

SYFOVRE® and IZERVAY®

>$1B combinedannual sales

2-3M

Patients

Recent Milestone

Positive 12-month Phase

2 data; first patient dosed

in Phase 3

Approved Products in US

2026

Phase 2 topline data released

2027

Complete enrollment

Ocugen – October 2026

FDA (RMAT)

1Akula et al. Gene Ther 2024; MOA= Mechanism of Action: anti-drusen activity (improves retinal function), anti-inflammatory (suppresses inflammation in HMC3 cells), anti-oxidative (improves ARPE19 cell survival), anti-complement (increases Cd59 protein)

OCU410 Aims to Disrupt GA Treatment Driven by a Novel MOA

Driving global change at the patient level

(2-3M patients in U.S. and EU )

GA Patient Experience RORA 4-way MOA1

Addresses all disease pathways – marketed therapies only

address the complement system

OCU410

Ocugen – October 2026

Endpoints

Randomization

1:1:1

EZ preservation (correlates to visual function)

ControlGroup

No Treatment

Primary:

Exploratory:

Medium Dose

1x 1010 vg per eye, 200 µL

High Dose

3x 1010 vg per eye, 200 µL

Phase 2 ArMaDa Trial: To Assess Safety and Efficacy of OCU410 in GA

TargetPopulation: Geographic atrophy secondary to dAMD

AMD

• Subjects 50 years and older

• BCVA of ≥21 ETDRS Letters

• Total GA area ≥2.0 and ≤ 20.5 mm2 (1 to 8 disk areas)

• GA within foveal and nonfoveal region

• CNV in fellow eye is not exclusionary

• Subjects who had a history of pegcetacoplan or

avacincaptad pegol use were enrolled with 3M

washout period

Key Protocol Inclusion Criteria:

Change in GA lesion size measured in mm2 by FAF at Month 12

Phase 2 (ArMaDa Trial): NCT06018558

OCU410

Ocugen – October 2026

Retinal Vasculitis and/or Retinal Vascular Occlusion

Choroidal Neovascularization

(CNV)

Intraocular Inflammation

Ischemic Optic Neuropathy

Treatment Emergent Serious Adverse Events

Treatment EmergentAdverse Events

Considered Severe

OCU410

Med Dose

(N=16)

Endophthalmitis and Retinal Detachments

Adverse Events (AE), Serious AEs, Adverse Events of

Special Interest (AESI)

OCU410

High Dose

(N=16)

Control

(N=13)

# Intraocular Inflammation deemed related to study procedure – resolved

*CNV reported as AEs were not related to OCU410 based on DSMB review

No OCU410-related SAEs and AESIs reported to date

OCU410 Demonstrates Favorable Safety and Tolerability Profile

OCU410

Ocugen – October 2026

Control Medium Dose

Lesion Size Reduction

31%

treated vs control

Phase 2 Data Driving Optimal Dose for Phase 3

References for Natural History: Mones and Biarnes, 2018, TVST, N=117;

For Primary Endpoint analysis evaluable subjects include controls (N=12) and medium dose (N=16); for EZ loss analysis, Controls (N=12) and medium dose (N=13)

GA Lesion ≥2.5 mm2 and ≤17.5mm2

(Lesion criteria in prior pivotal trials supporting approval); FAF= Fundus Autofluorescence; SD-OCT= Spectral Domain Optical Coherence Tomography;

Primary analysis conducted by MMRM and p-value <0.05

Phase 3 considerations: Dose -1x1010 vg per eye; Primary Endpoint – Lesion Size Reduction; Secondary Endpoint – EZ Preservation

EZ Preservation

27%

treated vs control

0.0

0.5

1.0

1.5

2.0

2.5

GA Lesion Area (mm

) Mean (±SEM) change from BL Control Medium Dose

-31%

Ellipsoid Zone Loss (SD-OCT; N=25)

(Correlates to Visual Function)

-27%

Change in GA Lesion Area (FAF; N=28)

EZ Area loss (%)

Change from BL

p < 0.05

No disease progression

in~20% of treated subjects

75% of treated subjects

showed >30% reduction in

lesion growth

OCU410

12 Months 12 Months

Ocugen – October 2026

OCU410 Demonstrates Statistically Significant Reduction in Lesion

Size at 12 Months

OCU410 shows ~2X effect size compared to approved therapies

References: Apellis OAKS/DERBY (Heier et al, Lancet, Product Insert), IvericGATHER 2 (Liao 2023, Khanani 2024, Lancet/Ophthalmology, Product Insert), Natural History Meta-analysis (Fleckenstein 2018, Ophthalmology). Change

from Baseline for OCU410 was against ArMaDa control subjects; Dropout rates for approved therapies reported after 10 injections (PIPER|SANDLER Industry Note, June 2025);

OCU410 Optimal Dose = Medium Dose

Potentially addresses current unmet need in treating GA:

• Potential one-time treatment for life versus 6-12 injections per year

• May overcome up to 40% drop-out reported in the current standard of care

Topline, 12-month efficacy results in Phase 1 and Phase 2:

• Promising efficacy in Phase 1 and Phase 2

• Apparent structural preservation on GA lesion

• EZ preservation may support visual function

Topline data suggests favorable safety and tolerability profile:

• No SAEs and AESIs deemed related to OCU410

% Reduction in lesion size compared to

control in reported studies

1.0

1.5

2.0

2.5

Pegacetacoplan Monthly @ 24M

Pegacetacoplan EOM @ 24M

Avacincaptad pegol @ 12M

OCU410 - Optimal dose @ 12M

Control (Natural History)

-22% -19% -15%

-31%

Mean Change of GA Area (mm²) from BL

OCU410

Ocugen – October 2026

Phase 3 – Assess Efficacy, Safety and Tolerability of OCU410 in GA

Trial Design Endpoints

Randomized 2:1(N=237)

Proportion of subjects

with LLVA ≥15 Letter Loss

from Baseline to M12 as

assessed by ETDRS visual

charts at two consecutive

visits

12-month change in EZ

Loss Area in study eyes

vs. control (SD-OCT)

TargetPopulation

Adults (55+years) with geographic atrophy secondary

to dry AMD (55+ years), early to late-stage disease

12-month change in GA

lesion size from baseline

vs. control

Measured in square

root mm by fundus

autofluorescence (FAF)

158

Treatment Group

1×1010 vg per eye in 200 µL

ControlGroup

No Treatment

MTD

Established in

Phase 1

Optimal Dose

established in

Phase 2

Primary Secondary

Ocugen – October 2026

Phase 3 ArMaDa Trial: NCT07770828

OCU410

Ocugen Hopes to Deliver on Its Promise to Transform the

Treatment Landscape for Patients with GA

OCU410 potentially creates a new standard of care

• First-in-class RORA MOA designed to support central retina and photoreceptor integrity

• Promising Phase 2 results indicate 31% reduction in lesion size and 27% slower EZ

loss

• Potential to eliminate treatment burden and patient fatigue to reduce treatment

attrition

• Optimized Phase 3 trial design and targeted GA lesion size for vision preservation

• Current Global Phase 3, n=~237, >95% power, Initiated in 3Q 2026, First patient dosed

OCU410

Ocugen – October 2026

Milestones

Anticipated Milestones – Three BLAs by 2028

Retinitis

Pigmentosa

Stargardt

Disease

Geographic

Atrophy

OCU400

OCU410ST

OCU410

100% Enrollment

Completion

Phase 3

Topline Data

Phase 2 Study Results Initiate Phase 3

2026 2027

1Q 2Q 3Q 4Q

Phase 3

Topline Data

BLA

Submission

Approval/

Launch

Approval/

Launch

BLA

Submission

1H 2H

2028

Phase 3

Enrollment Completion

1Q 2Q 3Q 4Q

BLA

Submission

Ocugen – October 2026

Advancing cures for blindness

IR@ocugen.com

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