Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference

Rhea-AI Summary

Oculis (Nasdaq: OCS) said it will present its late-stage ophthalmology and neuro-ophthalmology pipeline at the 2026 J.P. Morgan Healthcare Conference on Jan 14, 2026.

The company highlighted Privosegtor, granted breakthrough therapy designation for optic neuritis after ACUITY Phase 2 showed a mean +18 ETDRS letters at three months versus placebo, and announced the global PIONEER registrational program (PIONEER-1 started in Q4 2025). Oculis also expects DIAMOND Phase 3 topline results for OCS-01 in DME in Q2 2026 and plans an NDA submission in Q4 2026.

Positive

• Privosegtor received FDA breakthrough therapy designation
• ACUITY Phase 2: Privosegtor + steroid achieved a mean +18 ETDRS letters at 3 months
• PIONEER registrational program launched with three pivotal trials across two indications
• DIAMOND Phase 3 topline results for OCS-01 expected in Q2 2026 with NDA planned Q4 2026
• Addressable US market cited: $7B+ for optic neuropathies and $3B for DME

Negative

• PIONEER-1 enrollment is expected to begin shortly, so registration timelines remain dependent on enrollment pace
• Topline readouts for OCS-01 are pending in Q2 2026, creating near-term binary clinical risk
• Market opportunity estimates are projection-based and do not guarantee commercial uptake or approval

Key Figures

Optic neuropathy market $7B+ Potential U.S. market for optic neuritis and NAION

Privosegtor dose 3 mg/kg/day Dose used with IV methylprednisolone in ACUITY trial

Vision gain 18 letters Average LCVA gain at 3 months vs placebo in ACUITY

Clinically meaningful threshold 15-letter gain Three-line improvement considered clinically meaningful

Drug-related AEs 10.5% Headache and acne in two participants each

PIONEER trials 3 pivotal trials Registrational PIONEER program for Privosegtor

DME population 1.8 million Estimated diagnosed DME patients in the U.S.

DME market size $3 billion Estimated current U.S. DME market for OCS-01 opportunity

Market Reality Check

$23.07 Last Close

Volume Volume 127,194 is about 1.21x the 20-day average 104,878, indicating mildly elevated interest pre-conference. normal

Technical Shares at $20.97 are trading above the 200-day MA $18.76 and sit 9.14% below the 52-week high.

Peers on Argus

OCS is modestly higher ahead of its conference update, while key biotech peers show mixed moves: ABUS +1.46%, EYPT +0.26%, QURE +3.92%, TSHA flat, UPB +7.67%. No peers appeared in the momentum scanner and there are no same-day peer headlines, pointing to a stock-specific narrative rather than a sector rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 06	Regulatory milestone	Positive	+5.8%	FDA Breakthrough Therapy Designation for Privosegtor backed by ACUITY Phase 2 data.
Jan 05	Insider/admin filing	Neutral	-1.3%	Notification of RSU vesting and settlement for a director, administrative only.
Dec 09	Insider/admin filing	Neutral	+0.5%	Multiple director RSU vests and settlements disclosed for December 2025.
Dec 03	Insider/admin filing	Neutral	+1.1%	Single director RSU vesting event reported for November 29, 2025.
Nov 28	Insider/admin filing	Neutral	+0.0%	Director RSU vesting on November 25, 2025 disclosed without financial terms.

Pattern Detected

Recent history shows a strong positive reaction to substantive clinical/regulatory milestones (e.g., breakthrough therapy designation) and muted moves around routine administrative disclosures.

Recent Company History

Over the past months, Oculis has mainly issued administrative RSU vesting notices alongside one major clinical milestone. On Jan 6, 2026, the FDA granted Breakthrough Therapy Designation to Privosegtor in optic neuritis, supported by ACUITY Phase 2 data, and the stock moved +5.82%. In contrast, several RSU-related disclosures from Nov–Dec 2025 produced minimal price changes. Today’s 2026 J.P. Morgan presentation update extends that positive clinical narrative by emphasizing the same Privosegtor data and the late-stage OCS-01 DME program.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-10

An effective Form F-3 filed on Nov 10, 2025 registers the resale of up to 494,259 ordinary shares underlying a warrant. Oculis is not selling shares directly under this prospectus and would only receive warrant exercise proceeds in cash, so the filing primarily facilitates potential secondary sales by the selling securityholder.

Market Pulse Summary

The stock moved +5.0% in the session following this news. A strong positive reaction aligns with the article’s emphasis on late-stage assets and prior FDA recognition of Privosegtor. Historical data show that substantial regulatory or clinical milestones, such as the recent Breakthrough Therapy Designation, have coincided with notable upside moves. However, past equity financings and an effective resale shelf underline potential supply overhang if warrants are exercised. Investors have also reacted less to routine filings, suggesting news quality and clinical progress remain the primary drivers.

Key Terms

breakthrough therapy designation regulatory

"Breakthrough therapy designation granted as Company advances the PIONEER registrational program"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

optic neuritis medical

"granted breakthrough therapy designation by the U.S. FDA for the treatment of optic neuritis"

Inflammation of the optic nerve that can cause sudden vision loss, blurring, or eye pain, often like a camera lens fogging or an electrical wire briefly losing connection. It matters to investors because optic neuritis can signal safety issues for drugs or devices, affect regulatory approval, drive legal or clinical costs, and influence demand for treatments and diagnostic services—so reports of cases can move stock prices in healthcare and biotech names.

non-arteritic anterior optic neuropathy medical

"for Privosegtor in two indications: optic neuritis and a second rare neuro-ophthalmic disease, non-arteritic anterior optic neuropathy (NAION)."

Non-arteritic anterior optic neuropathy is a sudden loss of vision in one eye caused by a temporary drop in blood flow to the front part of the optic nerve, not by blood vessel inflammation. Think of it like a kink in a garden hose that starves a plant of water: the nerve cells are damaged and vision can be permanently reduced. Investors care because it shapes demand for medical treatments, affects clinical trial safety signals and regulatory decisions, and can create liability, insurance and productivity implications for companies.

diabetic macular edema medical

"OCS-01 eye drops in diabetic macular edema (DME) expected in Q2 2026"

Diabetic macular edema is an eye condition in which fluid leaks into and swells the macula, the part of the retina used for sharp, central vision, often as a complication of diabetes. For investors it matters because it drives demand for medicines, medical devices and eye-care services, influences clinical trial and regulatory outcomes, and can affect healthcare costs and revenue forecasts—think of the macula as the camera’s central lens that becomes blurred when it soaks up excess fluid.

ETDRS medical

"improvements in vision on the 2.5% ETDRS Low-Contrast Letter Acuity chart."

ETDRS (Early Treatment Diabetic Retinopathy Study) refers to a standardized eye chart and scoring system used in clinical trials to measure visual acuity. It converts how many letters a person can read on a chart into a numeric score, so doctors can track small but meaningful changes in sight. Investors care because ETDRS scores are common, objective endpoints in ophthalmology trials and can determine whether a treatment is judged effective.

neurofilament medical

"Additional analyses showed reduced neurofilament release, a biomarker of neuroaxonal damage"

A neurofilament is a structural protein that helps give nerve cells their shape and strength and is released into spinal fluid or blood when those cells are damaged; think of it like a building’s steel beam that sheds rust when the structure is harmed. Investors care because measuring neurofilament levels offers a simple, measurable signal of nerve injury used to track disease progression, select patients and show whether a drug is working in clinical trials, which can affect a therapy’s market prospects and risk profile.

biomarker medical

"reduced neurofilament release, a biomarker of neuroaxonal damage"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

NDA regulatory

"Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

AI-generated analysis. Not financial advice.

ZUG, Switzerland, Jan. 08, 2026 (GLOBE NEWSWIRE) --

• Breakthrough therapy designation granted as Company advances the PIONEER registrational program in optic neuropathies to create a potential market of $7B+ in the U.S. alone
• Multiple milestones anticipated from late-stage portfolio including topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) expected in Q2 2026
• Riad Sherif, M.D., Chief Executive Officer, will present at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 1.30pm PST
  

Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced that the transformative potential of its late-stage pipeline, including breakthrough therapy Privosegtor, the novel neuroprotective candidate in development for optic neuropathies, and novel eye drop candidate, OCS-01, for diabetic macular edema, will be highlighted in its company presentation at the upcoming 44^th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Oculis recently announced that Privosegtor, a neuroprotective candidate, has been granted breakthrough therapy designation by the U.S. FDA for the treatment of optic neuritis based on the successful ACUITY Phase 2 trial results. Privosegtor is a novel peptoid small molecule designed to cross both the blood–brain and retinal barriers and has the potential to become the first neuroprotective therapy for optic neuropathies. These serious conditions carry a significant unmet need as they can lead to permanent vision loss from nerve cell damage or death.

In the ACUITY trial, Privosegtor delivered substantial improvements in vision on the 2.5% ETDRS Low-Contrast Letter Acuity chart. Patients receiving Privosegtor 3mg/kg/day plus IV methylprednisolone gained an average of 18 letters at three months compared with placebo plus IV methylprednisolone. For context, a 15‑letter (three‑line) gain represents a two‑fold improvement in visual resolution and is considered clinically meaningful for patients. Privosegtor also showed anatomical preservation of retinal and optic nerve structure, which are typically damaged during acute optic neuritis. Additional analyses showed reduced neurofilament release, a biomarker of neuroaxonal damage, in conditions such as multiple sclerosis. The most common drug‑related adverse events (AEs) were headache and acne (each in two participants; 10.5%). No drug‑related serious AEs or AEs leading to treatment or study discontinuations occurred.

Following a successful meeting with the FDA in 2025, Oculis launched the PIONEER program, which includes three pivotal trials to support registration plans for Privosegtor in two indications: optic neuritis and a second rare neuro-ophthalmic disease, non-arteritic anterior optic neuropathy (NAION). These two optic neuropathies represent a potential market opportunity exceeding $7 billion in the U.S. alone, given the significant unmet medical need. The first trial in the program, PIONEER‑1 in optic neuritis, was initiated in Q4 last year. This global study spans three continents, sites activation is underway, and enrollment is expected to begin shortly.

Oculis’s most advanced product candidate, OCS-01, is currently in Phase 3 development and aims to be the first eye drop for diabetic macular edema (DME). In the U.S. alone, the diagnosed DME population is estimated to be around 1.8 million¹ and currently represents a ~$3 billion market opportunity¹ with high unmet medical needs for early intervention and for patients with inadequate response to standard of care, which could be addressed with OCS-01 eye drops, if approved. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for Q4 2026.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated “With Privosegtor advancing as a neuroprotective platform, starting with optic neuropathies as the initial focus, Oculis is uniquely positioned to transform the treatment landscape in areas with substantial unmet needs in neuro-axonal diseases, potentially creating a market exceeding $30 billion. 2026 is set to be a milestone-rich year across Oculis’ late-stage portfolio, including the much-anticipated OCS-01 DIAMOND Phase 3 trials readout in diabetic macular edema, which we look forward to in Q2 2026.”

Riad Sherif, M.D., Chief Executive Officer of Oculis, will present at the 44^th Annual J.P. Morgan Healthcare Conference as below:

Date: Wednesday, January 14, 2026
Time: 1:30pm (PST)
Venue: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA94102 (USA)

An audio webcast and replay of the presentation will be available on the J.P. Morgan website. The presentation will also be posted to the Oculis website on the Events & Presentation page under the Investors & Media section.

-ENDS-

About Privosegtor
Privosegtor, a novel peptoid small-molecule candidate that penetrates the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.

Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country.

About Optic Neuritis
Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis². It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)³. ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.

About Non-arteritic Anterior Ischemic Optic Neuropathy
Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute optic nerve disorder that causes permanent visual impairment in >60% of affected patients⁴. It is the most common cause of acute optic nerve injury in individuals over 50 years old⁵ and affects up to 10.2 per 100,000 people worldwide⁵ with a U.S. incidence estimated to be >30,000^5,7,8. In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies (in the retina) are permanently lost, leading to significant irreversible visual impairment or even blindness⁹. There are no approved therapies for NAION and the unmet medical need is for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.

About OCS-01 eye drops and the OPTIREACH® technology
Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH^® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH^® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye.  Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option.

OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country.

About Diabetic Macular Edema
Diabetic Macular Edema (DME) is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 2040^10,11. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients.

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
           
For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

References:

1. Decision Resources Group: DME – DR Landscape Forecast – Disease Landscape Forecast 2020
2. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
3. Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30.
4. Sing Hayreh S. (2008): Nonarteritic anterior ischemic optic neuropathy: natural history of visual outcome. Ophthalmology. 2088 Feb;115(2):298-305.
5. https://www.aao.org/eyenet/article/naion-diagnosis-and-management
6. Kupersmith, MJ et al. (2024): Ophthalmic and Systemic Factors of Acute Nonarteritic Anterior Ischemic Optic Neuropathy in the Quark207 Treatment Trial. 2024 July;131(7):790-802.
7. Hattenhauer M G et al. (1997): Incidence of nonarteritic anterior ischemic optic neuropathy. American Journal of Ophthalmology. 1997 Jan;123(1):103-7.
8. Lee M S et al. (2011): Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients. Ophthalmology 2011 Mar 24;118(5):959-963
9. North American Neuro-Ophthalmology Society website: https://www.nanosweb.org
10. Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564.
11. International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045.

FAQ

When will Oculis (OCS) present at the 2026 J.P. Morgan Healthcare Conference?

Oculis will present on January 14, 2026 at 1:30pm PST.

What clinical milestone did Privosegtor achieve for Oculis (OCS)?

Privosegtor received FDA breakthrough therapy designation for optic neuritis after ACUITY Phase 2 showed a mean +18 ETDRS letters at three months.

When are topline results for Oculis (OCS) OCS-01 DIAMOND Phase 3 expected?

Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026.

What regulatory filing does Oculis (OCS) plan for OCS-01 and when?

Oculis plans an NDA submission for OCS-01 to the FDA in Q4 2026 if results support filing.

What market size does Oculis (OCS) cite for Privosegtor and OCS-01 in the U.S.?

Oculis cites a >$7B U.S. opportunity for optic neuropathies and a ~$3B U.S. DME market.

What is the design/status of the PIONEER program for Privosegtor (OCS)?

PIONEER is a registrational program of three pivotal trials targeting optic neuritis and NAION; PIONEER-1 was initiated in Q4 2025 and global site activation is underway.