Form 8-K

8-K — Opus Genetics, Inc.

Accession: 0001140361-26-036277

Filed: 2026-09-11

Period: 2026-09-11

CIK: 0001228627

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ef20081922_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20081922_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20081922_8k.htm · Sequence: 1

false000122862700012286272026-09-112026-09-11

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): September 11, 2026

Opus Genetics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-34079

11-3516358

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

8 Davis Drive

Durham, NC

27713

(Address of principal executive offices)

(Zip Code)

(984) 884-6030

(Registrant’s telephone number, including area code)

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, $0.0001 par value per share

IRD

The Nasdaq Stock Market LLC

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.

On September 11, 2026, Opus Genetics, Inc. (the “Company”) issued a revised version of the Company’s data presentation, which

was initially used in connection with its investor conference on September 9, 2026, announcing clinical data from Cohort 1 of the Company’s ongoing Phase 1/2 clinical trial of OPGx-BEST1 in patients with BEST1-related retinal diseases. The

original data presentation was furnished by the Company on a Current Report on Form 8-K on September 9, 2026.

The revised version of the data presentation, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K, corrects

an immaterial error in the translation of logMAR visual acuity into ETDRS letters, which impacted the depiction of mean best-corrected visual acuity from baseline through 3 months in Cohort 1 on Slide 15. The correct three month change from

baseline for each participant is as follows: 101-101 had a 12 letter improvement in the treated eye and a 4 letter improvement in fellow eye, 101-104 had a 1 letter improvement in the treated eye and a 7 letter loss in the fellow eye, 102-101

had a 10 letter loss in the treated eye and an 8 letter loss in the fellow eye, 102-102 had a 2 letter gain in the treated eye and a 5 letter loss in the fellow eye, and 101-106 had a 6 letter gain in the treated eye and a 2 letter gain in the

fellow eye. In addition to the update on Slide 15, high-resolution images of the microperimetry grids for baseline and 3 months were added to the Appendix of the revised presentation for each participant. Individual loci data is available for the

three participants in these images.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Data presentation issued by Opus Genetics, Inc. on

September 11, 2026, furnished herewith

104

Cover page from this Current Report on Form 8-K, formatted in Inline XBRL

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.

OPUS GENETICS, INC.

Date:

September 11, 2026

By:

/s/ Dr. George Magrath

Dr. George Magrath

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20081922_ex99-1.htm · Sequence: 2

Exhibit 99.1

OPGx-BEST1 Gene Therapy Phase 1/2 Study Low Dose Cohort 1 3-month

Results September 9, 2026

This presentation contains forward-looking statements within the meaning of the

Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,”

“plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Such statements include, but are not limited

to, statements related to our continued clinical development, clinical results, preclinical data, and future plans for OPGx-BEST1, including the anticipated timing of dosing completion and topline data from Cohort 2 of the OPGx-BEST1 Phase

1/2 clinical trial; the outcome of our ongoing regulatory interactions with the U.S. Food and Drug Administration (the “FDA”) and our expectations regarding the design of, and potential endpoints for, of any pivotal clinical trial of

OPGx-BEST1; our expectations regarding the clinical and therapeutic potential of OPGx-BEST1, including with respect to its ability to improve visual function and retinal structure in patients with BEST1-related retinal disease; our estimates

of the BEST1 symptomatic patient population in the U.S. and globally; and our expectations regarding our company, its business prospects, and our results of operations. These forward-looking statements are subject to certain risks and

uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to

such differences include, but are not limited to: our clinical data related to gene therapies for the treatment of inherited retinal diseases is preliminary and related to a relatively small group of patients, and, as a result, data that

initially appears promising may be revised, updated, or invalidated at a later data readout and/or may ultimately not be capable of duplication in additional patients; our gene therapy product candidates are based on a novel technology that

is difficult to develop and manufacture, which may result in delays and difficulties in obtaining regulatory approval; our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that

may not satisfy the FDA requirements to further develop our therapeutic products; delays or difficulties associated with patient enrollment in clinical trials may affect our ability to conduct and complete those clinical trials and obtain

necessary regulatory approvals; changes in regulatory requirements could result in increased costs or delays in development timelines; we depend heavily on the success of our product pipeline; if we fail to find strategic partners or fail to

adequately develop or commercialize our pipeline products, our business will be materially harmed; we have not generated significant revenue from sales of any products and expect to incur losses for the foreseeable future; our future

viability is difficult to assess due to our short operating history and our future need for substantial additional capital, access to which could be limited by any adverse developments that affect the financial services markets; we rely on

third parties for material aspects of our business, such as conducting our nonclinical and clinical trials and supplying and manufacturing bulk drug substances, which exposes us to certain risks; and those risks and uncertainties described

under the heading “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and our subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”). Readers are cautioned not to

place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might

subsequently arise. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Disclosures and Forward-Looking Statements 2

3 Management Team and KOL Participant Ash Jayagopal, PhD, MBA Chief

Scientific & Development Officer Sally Tucker, MCOptom, PhD Chief Medical Officer Rob Gagnon, CPA, MBA Chief Financial Officer Mark E. Pennesi, MD, PhD, FARVO Retina Foundation of the Southwest Dallas, TX George Magrath, MD Chief

Executive Officer Ben Yerxa, PhD President

Well-tolerated with no SAEs, no DLTs, and no intraocular

inflammation Structural and functional improvements at 3 months FDA meeting aligned on potential pivotal endpoint ≥3 dB microperimetry improvement in ≥5 prespecified loci In conjunction with a RCT using the PGI-S Phase 3 and commercial

manufacturing on schedule for delivery in early 2027 Cohort 2 overenrolled at 8 participants, weighted towards earlier stage BVMD 6-month Low-Dose Cohort 1 and 3-month High-Dose Cohort 2 data expected in Q2 2027 Pivotal trial to commence

dosing in 2027 New epidemiology report surveying 150 eye care professionals estimates 23,600 BEST1 patients in the U.S. 4 OPGx-BEST1 Program and Low-Dose Cohort 1 Clinical Data Highlights BEST1, bestrophin 1; BVMD, best vitelliform

macular dystrophy; dB, decibel; DLT, dose-limiting toxicity; FDA, Food and Drug Administration; PGI-S, patient global impression-severity; RCT, randomized controlled trial; SAE, serious adverse event. OPGx-BEST1 Cohort 1 & Program

Summary T O D AY ’ S T O P I C S 01 O p u s & B E S T 1 O v e r v i e w 0 2 T r i a l D e s i g n & To p l i n e R e s u l t s 03 P a r t i c i p a n t C a s e S t u d i e s 04 P r o g r a m S u m m a r y & N e x t S t

e p s 75% of evaluable participants met the FDA-aligned microperimetry of ≥3 dB improvement in ≥5 prespecified loci

Building a Differentiated Gene Therapy Platform Opus Genetics owns worldwide

rights to all gene therapy programs. adRP, autosomal dominant retinitis pigmentosa; BEST1, bestrophin 1; CNGB1, cyclic nucleotide-gated channel β1; FDA OOPD, Food and Drug Administration Office of Orphan Products Development; FFB, Foundation

Fighting Blindness; GTx, gene therapy; LCA5, Leber congenital amaurosis 5; NIH, National Institutes of Health; RD, retinal degeneration; RDH12, retinol dehydrogenase 12; RHO, rhodopsin; RP, retinitis pigmentosa; MERTK, MER proto-oncogene

tyrosine kinase; NMNAT1, nicotinamide mononucleotide adenylyltransferase. 5 OPGx-LCA5 LCA co-funded by FDA OOPD OPGx-BEST1 Bestrophinopathies OPGx-RDH12 LCA co-funded by Global RDH12 Alliance OPGx-MERTK RP co-funded by FFB RD Fund

& Abu Dhabi’s Healthcare Research and Innovation Fund OPGx-RHO adRP co-funded by FFB & NIH OPGx-NMNAT1 LCA OPGx-CNGB1 RP NIH-funded consortium Undisclosed IRD GTx Preclinical IND-enabling Phase 1/2 Phase 3 Approval All gene

therapy programs have the potential to qualify for a Priority Review Voucher

6 BEST1: Group of Inherited Retinal Diseases with a Range of Onset and Slow

Rate of Progression and no Approved Treatment Options Overview & Prevalence Mutations in BEST1 have been associated with at least five clinically distinct retinal degenerative diseases, with onset from childhood to adulthood1 Accounts

for ~3.5% of all IRDs1 Global prevalence*: ~45,400 patients2 U.S. prevalence: 23,600 patients (~23,200 BVMD and ~400 ARB)2 Clinical Features1,3 Serous retinal detachment BVMD (most common) is characterized by vitelliform

(“egg-yolk”) lesion beneath the macula1 Macular atrophy CNV Symptoms3,4 Loss of central vision Metamorphopsia (distorted vision) Scotoma (blind spot) Photophobia4 *Global prevalence estimate includes United States, EU4 (France,

Spain, Germany, & Italy), UK, Middle East/North Africa, and China. ARB, autosomal recessive bestrophinopathy; BEST1, bestrophin 1; BVMD, best vitelliform macular dystrophy; CNV, choroidal neovascularization; IRD, inherited retinal

disease. 1. Amato A, et al. Saudi J Ophthalmol. 2023;37(4):287-295. 2. BEST1 Market Landscape Quantitative Market Research, Triangle Insights Group, Q3 2026. 3. Johnson AA, et al. Prog Retin Eye Res. 2017;58:45-69. 4. Tripathy K, et al.

StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. BVMD ARB Most Common BEST1 Phenotypes Prevalence BVMD 23,200 (98%)2 ARB 400 (2%)2

BEST1 gene encodes for bestrophin-1, a homopentameric (i.e., 5 identical

monomers) Ca2+-activated chloride channel required for RPE maintenance and retinal physiology BEST1 mutations in BVMD disrupt cellular ion and fluid homeostasis resulting in electrophysiological abnormalities, RPE dysfunction, and retinal

degeneration via: Defective clearance of toxic waste products (e.g., lipid deposits) Impaired RPE-photoreceptor interactions (e.g., defective phagocytosis) Build-up of vitelliform material (toxic waste products) and fluid under the

retina BEST1 Disease Biology BEST1, bestrophin 1; BVMD, best vitelliform macular dystrophy; RPE, retinal pigment epithelium. Guziewicz KE, et al. Prog Retin Eye Res. 2017;58:70-88. A T R O P H Y F R A G M E N T E D V I T E L L I F O R M

MA T E R I A L S U B R E T I N A L F L U I D P S E U D O H Y P O P Y O N Photoreceptors Retinal Pigment Epithelium Bruch’s Membrane Choriocapillaris V I T E L L I F O R M L E S I O N V I T E L L I F O R M D E P O S I T S STAGE

1 Pre-vitelliform STAGE 2 Vitelliform STAGE 3 Pseudohypopyon STAGE 4 Vitelliruptive STAGE 5 Atrophy/Fibrosis S t a g e s o f B V M D 7 Cohort 1 Participants Vitelliform material occurs early and is the hallmark of

BVMD Subretinal fluid occurs late in disease and pools in atrophic areas

8 Trial Design & Topline Cohort 1 Results Sally Tucker, MCOptom, PhD

Chief Medical Officer

OPGx-BEST1: Phase 1/2 Study Overview (BIRD-1) D e s i g n Adaptive,

open-label, dose-exploration, safety and tolerability study of subretinal injection of OPGx-BEST1 in adult participants with BVMD or ARB D o s i n g C o h o r t s Cohort 1: 1.5x109 vg/eye Cohort 2: 4.5x109 vg/eye O b j e c t i v e

s Primary: Safety and tolerability; identify appropriate dose for Phase 3 Secondary: Efficacy S t u d y P o p u l a t i o n Minimum of 5 participants at each dose level S t a t u s o f C o h o r t 1 ( l o w d o s e ) 5 participants

dosed: ARB (n=2): Data at 6 months BVMD (n=3): Data at 3 months S t a t u s o f C o h o r t 2 ( h i g h d o s e ) Enrollment complete with 8 participants (7 surgeries scheduled) Dosing expected to be completed in Q4 2026 ARB, autosomal

recessive bestrophinopathy; BVMD, best vitelliform macular dystrophy. 9

*ETDRS letters equivalent calculated from logMAR. † Worse eye deemed study

eye. ARB, autosomal recessive bestrophinopathy; BEST, bestrophin; BVMD, best vitelliform macular dystrophy; ETDRS, Early Treatment Diabetic Retinopathy Study; RPE, retinal pigment epithelium; VA, visual acuity. Participant Demographics:

Low-Dose Cohort 1 101-101 101-104 102-101 102-102 101-106 Age 63 59 50 45 31 Sex Female Female Male Male Male BEST phenotype ARB ARB BVMD BVMD BVMD Baseline VA* (study eye†) 1 50 49 61 47 Baseline VA* (fellow

eye) 43 65 68 72 56 Follow-up duration 6 months 6 months 3 months 3 months 3 months Severity of disease End-stage with significant atrophy End-stage with significant atrophy End-stage with sub-foveal, sub-RPE scar Advanced

stage vitello-eruptive with some scarring Earlier stage without significant atrophy or scarring 10

Study Endpoints M i c r o p e r i m e t r y Measures pointwise sensitivity of

the retina over the lesion Recent natural history data shows a steady decline over 5 years in BVMD, with most of the decline in the area on the edge of the lesion1 B C VA & L LVA Methods to measure central fine visual function C o n

t r a s t S e n s i t i v i t y Measures visual function and is sensitive in patients with central atrophy (used extensively in geographic atrophy studies) A u t o f l u o r e s c e n c e A 2-dimensional picture of the retina highlighting

vitelliform lesions O C T A cross-sectional view of the retina BCVA, best-corrected visual acuity; BVMD, best vitelliform macular dystrophy; LLVA, low-luminance visual acuity; OCT, optical coherence tomography. 1. Bianco L, et al. Invest

Ophthalmol Vis Sci. 2026;67(11):1. 11

Safety and Efficacy Summary: Highly Encouraging Proof-of-Concept Results from

Low-Dose Cohort 1 S a f e t y OPGx-BEST1 was well-tolerated in 5/5 participants, with no SAEs or DLTs S t r u c t u r a l E n d p o i n t s 80% of participants (4/5) had structural improvements: BVMD: 67% of participants (2/3) had a

decrease in vitelliform material ARB: 100% of participants (2/2) had a decrease in intraretinal fluid F u n c t i o n a l E n d p o i n t s 100% of participants (5/5) had improvements* in at least one functional measure: Microperimetry –

75% of participants (3/4) improved BCVA – 60% of participants (3/5) improved LLVA – 40% of participants (2/5) improved Contrast Sensitivity – 40% of participants (2/5) improved Earlier-stage participant (101-106)† showed the biggest

functional gains, suggesting a potential benefit from earlier treatment *Improvements defined as: ≥5 letters of improvement from baseline and ≥5 letter improvement from fellow eye in BCVA or LLVA, 0.2 logMAR improvement from baseline in

contrast sensitivity, and ≥5 loci cluster improvement by ≥3 decibels in RPE Transitional Zone on microperimetry. †101-106 was the youngest participant with most recent onset of disease and less progressive disease than other

participants. ARB, autosomal recessive bestrophinopathy; BCVA, best-corrected visual acuity; BVMD, best vitelliform macular dystrophy; DLT, dose-limiting toxicity; LLVA, low-luminance visual acuity; logMAR, logarithm of the minimum angle of

resolution; RPE, retinal pigment epithelium; SAE, serious adverse event. 12

Well-tolerated in 100% of participants No intraocular inflammation No serious

adverse events No dose-limiting toxicities No treatment-related systemic AEs All ocular treatment-related AEs were mild/moderate in severity No vital sign issues or safety lab findings of note OPGx-BEST1 Demonstrated a Favorable Safety

Profile Independent Data Monitoring Committee recommended the Phase 1/2 Trial advance to Cohort 2 at higher dose No intraocular inflammation was observed in any patient at any study visit *Based on the SUN Working Group Grading

Scheme. AE, adverse event; ARB, autosomal recessive bestrophinopathy; BVMD, best vitelliform macular dystrophy; . 101-101 101-104 (ARB) (ARB) 102-101 (BVMD) 101-106 (BVMD) 0 102-102 (BVMD) 1+ 2+ (cells in field)* 3+ 4+ 13

Participant-Level Improvement by

Endpoint* Endpoint 101-101 ARB 101-104 ARB 102-101 BVMD 102-102 BVMD 101-106 BVMD BCVA ≥5 letter improvement compared to baseline and fellow eye ✓ ✓ ✓ LLVA ≥5 letter improvement compared to baseline and fellow

eye ✓ ✓ Contrast Sensitivity ≥0.2 logMAR improvement from baseline ✓ ✓ Microperimetry ≥5 loci cluster improvement ≥3 dB NE ✓ ✓ ✓ OCT IRF / vitelliform material reduced ✓ ✓ ✓ ✓ Improvement NE: Not evaluable *Improvement

defined as: ≥5 letters of improvement from baseline and ≥5 letter improvement from fellow eye in BCVA or LLVA, ≥0.2 logMAR improvement from baseline in contrast sensitivity, and ≥5 loci cluster improvement by ≥3 decibels in RPE Transitional

Zone on microperimetry. ARB, autosomal recessive bestrophinopathy; BCVA, best corrected visual acuity; BVMD, best vitelliform macular dystrophy; dB, decibel; IRF, intraretinal fluid; LLVA, low luminance visual acuity; logMAR, logarithm of

the minimum angle of resolution; OCT, optical coherence tomography; RPE, retinal pigment epithelium. 14

-4 -6 -2 0 2 4 8 6 Baseline M1 M3 Change from Baseline in BCVA (ETDRS

Letters) All Treated Eyes (N=5) All Fellow Eyes (N=5) Treated Eyes with Structural Improvement (N=4)* Corresponding Fellow Eyes (N=4)* Mean BCVA Improved from Baseline Through 3 Months in Cohort 1 *Excludes Participant 102-101 due to

significant foveal atrophy (with a subfoveal, sub-RPE scar) at baseline, likely exclusionary from the pivotal trial. Participant 102-101 had a 0.2 logMAR decrease in vision from baseline, all other participants had an improvement in vision;

Participant 102-101 had a meaningful improvement in contrast sensitivity. Error bars represent the standard error of the mean. BCVA, best corrected visual acuity; ETDRS, Early Treatment of Diabetic Retinopathy Study; M, month; RPE, retinal

pigment epithelium. +5 Letters -2 Letters 15

Defining the Transitional Zone Border area surrounding the atrophic lesion with

RPE and photoreceptors that are structurally intact but functionally compromised or at risk of imminent atrophic progression Highest potential to be rescued with OPGx-BEST1 Treated RPE Transitional Zone is the area of rescuable

photoreceptors around the atrophic lesion where OPGx-BEST1 treatment is administered New natural history data1: Untreated BVMD sensitivity only declines with highest rate detected in the transition zone – No untreated eye met the 3 dB

improvement threshold, consistent with fellow eyes in Cohort 1 Microperimetry Showed BVMD Improvement in the Treated RPE Transitional Zone *All eyes includes all evaluable patients (n=4); 101-101 could not complete microperimetry due to low

vision. †Improvement is defined as ≥5 loci area within the treated transitional zone improving by ≥3 dB from baseline. BVMD, best vitelliform macular dystrophy; dB, decibel; FDA, Food and Drug Administration; RPE, retinal pigment

epithelium. 1. Bianco L, et al. Invest Ophthalmol Vis Sci. 2026;67(11):1. 3/4 evaluable participants* demonstrated retinal sensitivity † improvement in the Transitional Zone 75% Treated Area Treated RPE Transitional Zone showing all

loci that improved by ≥3 dB (circled) correlate with reduced vitelliform material Central atrophy Autofluorescence Microperimetry FDA aligned on ≥3 dB change from baseline in ≥5 loci in treated RPE Transitional Zone anchored to a patient

reported outcome Reduction in vitelliform material 16

BVMD: 67% of participants (2/3) had reduction in vitelliform material on

multimodal imaging All three BVMD participants had improvements in visual function, with highest gains in areas of vitelliform material reduction ARB: 100% of participants (2/2) had reduction in intraretinal fluid on OCT Both ARB

participants had improvements in visual function in areas where intraretinal fluid decreased Functional gains were co-localized to structural improvements Retinal sensitivity improved in the treated transitional zone at the edge of the

lesion where fluid was minimal Fixation moved from outside the lesion to within the lesion in all four evaluable participants Areas of the transitional zone treated within the subretinal bleb had the highest functional gains Structural

Improvements Seen in BVMD and ARB Participants Results I nform Future E nrollment Earlier-stage participants showed the greatest structural and functional improvements, suggesting earlier intervention may yield improved outcomes 17 ARB,

autosomal recessive bestrophinopathy; BVMD, best vitelliform macular dystrophy; OCT, optical coherence tomography. A T R O P H Y F R A G M E N T E D V I T E L L I F O R M M A T E R I A L S U B R E T I N A L F L U I D P S E U D O H Y P O P

Y O N Photoreceptors Retinal Pigment Epithelium Bruch’s Membrane Choriocapillaris V I T E L L I F O R M L E S I O N V I T E L L I F O R M D E P O S I T S STAGE 1 Pre-vitelliform STAGE 2 Vitelliform STAGE 3 Pseudohypopyon STAGE

4 Vitelliruptive STAGE 5 Atrophy/Fibrosis S t a g e s o f B V M D

Post-Treatment Participant Feedback 101-101 ARB Able to see on the eye chart

for the first time in 30 years Wants the second eye treated 102-102 BVMD Wants the second eye treated Reports less eye strain after prolonged computer work; colors on TV appear brighter and clearer Happy with the study, mostly stable

vision 101-104 ARB 102-101 BVMD 101-106 BVMD ARB, autosomal recessive bestrophinopathy; BVMD, best vitelliform macular dystrophy. 18

Participant Case Studies & Next Steps Ash Jayagopal, PhD, MBA Chief

Scientific and Development Officer 19

Baseline Month 3 Participant 101-106 (BVMD): Microperimetry

Improvements Treated transitional zone follows the vitelliform arc as seen on fundus autofluorescence and OCT. Microperimetry loci were not pre-specified. BVMD, best vitelliform macular dystrophy; dB, decibel; OCT, optical coherence

tomography; TTZ, treated transitional zone; TZ, transitional zone. Threshold for success: ≥3 dB Average improvement in TTZ = 3.125 dB Fellow eye TZ = 0.5 dB 7 loci had ≥3 dB improvement (circled) This participant met the

microperimetry threshold for success of ≥3 dB 20

Baseline Month 3 Participant 101-106 (BVMD): Vitelliform Material Reduction

Co-localized with Microperimetry Improvements BVMD, best vitelliform macular dystrophy; dB, decibel; RPE, retinal pigment epithelium. Lesion reduction consistent with improved function of RPE cells and treatment activity as indicated in

microperimetry improvements Vitelliform lesions reduced B a s e l i n e M o n t h 3 21

Baseline Month 3 Participant 102-102 (BVMD): Microperimetry

Improvements Yellow box represents the treated transitional zone. Microperimetry loci were not prespecified. BVMD, best vitelliform macular dystrophy; dB, decibel; TTZ; treated transitional zone; TZ, transitional zone. Threshold for

success: ≥3 dB Average improvement in TTZ = 3.5 dB Fellow eye TZ = 0.5 dB 6 loci had ≥3 dB improvement (circled) – clustered within the TTZ This participant met the microperimetry threshold for success of ≥3 dB 22

Baseline Month 3 Participant 102-102 (BVMD): Microperimetry Improved in the

Treated RPE Transitional Zone Baseline Month 3 B a s e l i n e M o n t h 3 Vitelliform material decreased Yellow box represents treated transitional zone. BVMD, best vitelliform macular dystrophy; RPE, retinal pigment

epithelium. Fixation moves to a more natural location in the fovea 23

Participant 102-101 (BVMD): Photoreceptor and RPE Atrophy Limit

Improvement Images are consecutive registered OCT rasters at baseline, 1 month, and 3 months. *CS improvements defined as ≥2 dB change from baseline. BVMD, best vitelliform macular dystrophy; CS, contrast sensitivity; OCT, optical

coherence tomography; RPE, retinal pigment epithelium. Most advanced BVMD participant Sub-RPE atrophy and scarring, exclusionary from a potential pivotal trial Vitelliform material changes over time CS improvements* akin to observations

in geographic atrophy 3 Months Baseline 1 Month 24

P a r a f o v e a l A r e a I n f e r i o r A r e a Baseline Month 3 Month

6 Participant 101-101 (ARB): Functional and Structural Outcomes Through 6 Months Functional improvement maintained to 6 months on BCVA, CS, and LLVA Unable to perform MP due to poor baseline vision IRF decreased at 3 months in the

parafoveal area Fluctuations observed in both areas between 3 and 6 months ARB, autosomal recessive bestrophinopathy; BCVA, best-corrected visual acuity; BL, baseline; CFB, change from baseline; CS, contrast sensitivity; IRF, intraretinal

fluid; LLVA, low luminance visual acuity; M, month, MP, microperimetry; OD, right eye; OS, left eye. BL M1 M2 M3 M4 M5 M6 12 9 9 0 5 10 15 BCVA CFB (Letters equivalent) Study Eye - OS (Treated) Fellow Eye - OD (Untreated) 25

Participant 101-104 (ARB): Microperimetry Improvement Baseline Month 6 Total

macular IRF volume = 19.06 µl at baseline, 7.55 µl at 6 months. Microperimetry loci were not prespecified. ARB, autosomal recessive bestrophinopathy; dB, decibel; IRF, intraretinal fluid; RPE, retinal pigment epithelium; TTZ; treated

transitional zone. Threshold for success: ≥3 dB Average improvement in area of IRF = 3.3 dB Fellow eye corresponding area = 2.3 dB 16 loci had ≥3 dB improvement (circled) – clustered within the TTZ This participant met the

microperimetry threshold for success of ≥3 dB 26

Participant 101-104 (ARB): IRF Improvement Co-localized with Microperimetry

Improvement Baseline Month 6 Yellow circles denote pockets of intraretinal fluid. Total macular intraretinal fluid volume: Baseline = 19.06 µl, Month 6 = 7.55 µl. ARB, autosomal recessive bestrophinopathy; IRF, intraretinal

fluid. Fixation moves to a more natural location in the fovea Two areas of baseline intraretinal fluid 27

4 milestones cleared on the path to pivotal OPGx-BEST1 Advancing Based on

Positive Cohort 1 Results 1 2 3 4 Well-tolerated with no SAEs, no DLTs, and no intraocular inflammation Efficacy observed on both functional and structural endpoints Positive FDA Type C meeting aligned on potential pivotal endpoint with

microperimetry 28 CMC, chemistry, manufacturing, and controls; dB, decibel; DLT, dose-limiting toxicity; FDA, Food and Drug Administration; IDMC, independent data monitoring committee; SAE, serious adverse event. 75% of Cohort 1 evaluable

participants met the microperimetry threshold for success of ≥3 dB

Program Summary and Next Steps George Magrath, MD Chief Executive Officer 29

Accomplished Significant OPGx-BEST1 Program Milestones P H 1 / 2 C O H O R T 2

S TAT U S D o s e 4.5x109 vg/eye E n r o l l m e n t Already over-enrolled Originally planned for 5 participants Over-enrollment of 8 participants C l i n i c a l D e v e l o p m e n t T i m e l i n e * Dosing expected to be completed

Q4 2026 Topline 3-month data expected Q2 2027 Pivotal trial planning initiated, dosing expected in 2027 R E G U L AT O R Y S TAT U S A u g u s t 2 0 2 6 F D A Ty p e C m e e t i n g Aligned on Phase 3 CMC Constructive dialogue on

potential endpoint options for Phase 3 P o t e n t i a l P i v o t a l E n d p o i n t s Use of ≥3 dB microperimetry improvement in ≥5 prespecified loci area and; Randomized controlled trial with a patient-reported outcome BCVA, LLVA,

contrast sensitivity may also be acceptable endpoints N e x t R e g u l a t o r y I n t e r a c t i o n Following early data from Cohort 2 *Clinical development timelines are based on current estimates and are subject to change; data

readouts are targeted for ~9-12 months after study initiation. ARB, autosomal recessive bestrophinopathy; BCVA, best corrected visual acuity; BVMD, best vitelliform macular dystrophy; CMC, chemistry, manufacturing, and controls; dB,

decibels; FDA, Food and Drug Administration; LLVA, low luminance visual acuity. 30

Current Cash to Support Multiple Clinical Inflection Points 2027 BEST1 Pivotal

Study Start Q1 2027 MERTK clinical study initiation Q4 2026 RDH12 clinical study initiation Q4 2026 LCA5 Phase 3 dosing initiation Oct 2026 PDUFA date for Phentolamine sNDA Sept 2026 BEST1 Phase 1/2 Cohort 1

3-month results Current cash runway extends into 2029, funding five clinical programs through multiple critical inflection points 4 Clinical Data Readouts Expected in 2027: BEST1, LCA5, RDH12, MERTK Clinical development timelines are

based on current estimates and are subject to change; data readouts are targeted for ~9-12 months after study initiation. Phentolamine ophthalmic solution 0.75% is a commercial partnered program; it is FDA-approved for the treatment of

pharmacologically-induced mydriasis; an sNDA has been submitted for the treatment of presbyopia. BEST1, bestrophin 1; LCA5, Leber congenital amaurosis 5; MERTK, MER proto-oncogene tyrosine kinase; PDUFA, Prescription Drug User Fee Act; PRV,

Priority Review Voucher; RDH12, retinol dehydrogenase 12; RHO, rhodopsin; sNDA, supplemental New Drug Application. Q2 2027 BEST1 Cohort 2 results 31

N a s d a q : I R D

33 Mark E. Pennesi, MD, PhD, FARVO Leading ophthalmologist, researcher

specializing in inherited retinal diseases, and pioneer in gene therapy Current Appointments Chief Medical Officer, Steve and Debbie Gray Inherited Retinal Degeneration Endowed Chair; Director, Inherited Retinal Degeneration Center – Retina

Foundation, Dallas, Texas Adjunct Professor of Ophthalmology – Paul H. Casey Ophthalmic Genetics Division, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon Education B.S. in Biomedical Engineering, University

of Pennsylvania (summa cum laude); Combined MD/PhD, Baylor College of Medicine; Ophthalmology residency, UCSF; Ophthalmic genetics fellowship, Casey Eye Institute/OHSU Research and Awards Research focuses on developing novel treatments for

inherited retinal diseases Author of 170+ peer-reviewed publications; principal or co-principal investigator on numerous first-in-human gene therapy trials Research to Prevent Blindness and the Foundation Fighting Blindness have recognized

Dr. Pennesi with career development awards; Additionally, he was the recipient of the 2011 ARVO/Alcon Early Clinician Scientist, the Alcon Young investigator Award in 2014, and the Casey Eye Institute Resident teach award

34 Q&A with Opus Management and Dr. Pennesi Ash Jayagopal, PhD, MBA Chief

Executive Officer Ben Yerxa, PhD President

Appendix 35

36 Triangle Insights Group Research, Q3 2026. BEST1 Market Landscape

Quantitative Market Research Patient Group Definition Est. Value Genetic BEST1 genotype (with or without symptoms) ~46,000 – 87,000 patients Symptomatic Diagnosed + undiagnosed (with ocular symptoms) ~23,600 patients Diagnosed

(Post-onset) Diagnosed (with ocular symptoms) ~13,000 patients Diagnosed (Genetically Confirmed) Diagnosed with genetic confirmation ~8,400 patients Undiagnosed (Post-onset) Undiagnosed (with ocular symptoms) ~10,600 patients BEST1

Patients: Estimated Inputs Symptomatic 23,600 pts Undiagnosed: 10,600 pts Diagnosed (Post-Onset) 13,000 pts Diagnosed (Genetic) 8,400 pts BEST1 Mutation: Estimated Subpopulations Genetic 46,000 – 87,000 pts

37 101-106 Microperimetry B a s e l i n e M o n t h 3

38 102-102 Microperimetry B a s e l i n e M o n t h 3

39 101-104 Microperimetry B a s e l i n e M o n t h 6

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