dexamethasone cyclodextrin nanoparticle ophthalmic suspension (OCS-01) / Oculis - LARVOL DELTA

A Phase II, prospective, multi-center, single masked, randomized, controlled, study to determine the efficacy and safety of dexamethasone ophthaLmic suspension Eye drOps in uveitic and Post-surgicAl maculaR eDema: The LEOPARD Study (ARVO 2024) - "OCS-01 up to 6 drops daily has been well tolerated by subjects with CME who have received OCS-01 treatment. The ongoing study will examine the efficacy and safety of OCS-01. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P2 data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

BCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME From DIAMOND-Stage 1 trial (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Diabetic Macular Edema • Ophthalmology

Safety and efficacy of topical OCS-01 ophthalmic suspension for the treatment of diabetic macular oedema: stage 1 of a multicentre, double-blind, randomised, vehicle-controlled phase 2/3 trial. (PubMed, EClinicalMedicine) - P2/3 | "The dosing regimen was found to be appropriate for use in Stage 2, which will provide longer-term data. Oculis Sàrl, Lausanne, Switzerland."

Journal • P2/3 data • Cardiovascular • Diabetic Macular Edema • Macular Edema • Ophthalmology

Oculis Holding AG…announced topline results from its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME) (GlobeNewswire) - "The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52, was not met in both trials. The secondary endpoint of retinal thickness, as measured by OCT, showed a substantial and persistent reduction with OCS-01 vs vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1. The key secondary endpoint of the proportion of patients with ≥15-letter gain in BCVA was not met in both trials....Based on the results, at this time, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME."

P3 data: top line • Diabetic Macular Edema

DIAMOND-1: A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1) (clinicaltrials.gov) - P2/3 | N=552 | Completed | Sponsor: Oculis | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

DIAMOND-2: A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2) (clinicaltrials.gov) - P3 | N=401 | Completed | Sponsor: Oculis | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Oculis Announces Completion of Last Patient Visit in Phase 3 DIAMOND Program with OCS-01 Eye Drops for the Treatment of Diabetic Macular Edema (GlobeNewswire) - "The last patient in the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, consisting of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52 weeks of treatment, completed the final study visit in April 2026....Oculis expects to report topline data from both pivotal trials in June, followed by a potential NDA submission in Q4 2026."

FDA filing • P3 data: top line • Trial status • Diabetic Macular Edema

Oculis to Participate in Upcoming Investor Conferences (Oculis Press Release) - "Oculis is pleased to present updates of its innovative, highly differentiated, late-stage portfolio. 2026 promises to be a landmark year for the company in its transformation into a leader in neuro-ophthalmology and ophthalmology. Key highlights include: OCS-01 (DIAMOND Phase 3 trials) topline pivotal results in diabetic macular edema (DME) on track for June 2026; Licaminlimab (PREDICT-1 registrational trial) being evaluated as the first genotype-based development program to drive precision medicine in dry eye disease (DED) with topline results planned around late 2026."

P3 data: top line • Diabetic Macular Edema • Dry Eye Disease

Recent Clinical Highlights and Upcoming Milestones: OCS-01 [Google translation] (GlobeNewswire) - "Both Phase 3 DIAMOND trials with OCS-01, which aims to be the first eye drop therapy for DME, have enrolled over 800 patients and are nearing completion. Topline results are expected in Q2 2026, and, if positive, a subsequent NDA submission to the FDA is planned for Q4 2026. "

P2/3 data • P3 data: top line • Diabetic Macular Edema

DIAMOND-1: A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1) (clinicaltrials.gov) - P2/3 | N=552 | Active, not recruiting | Sponsor: Oculis | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

DIAMOND-2: A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2) (clinicaltrials.gov) - P3 | N=401 | Active, not recruiting | Sponsor: Oculis | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

LEOPARD: Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Quan Dong Nguyen | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone)...Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders

LEOPARD: Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Quan Dong Nguyen | Recruiting ➔ Active, not recruiting

Enrollment closed • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Oculis Hosts R&D Event Today to Showcase Progress on All Three Pipeline Assets (GlobeNewswire) - "The event will feature several world-renowned key opinion leaders (KOLs), and the presentations will cover: An update on the execution of the two Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME), with enrollment for both studies completed (>800 patients) and topline data anticipated in Q2 2026; The genotype-based development plan to drive a personalized approach in dry eye disease (DED) and Phase 2/3 study design for Licaminlimab (OCS-02) is anticipated to start in 2H 2025; An expanded data analysis from the ACUITY Phase 2 trial and future development plans for Privosegtor (OCS-05) in acute optic neuritis (AON). Two new programs will be announced utilizing Privosegtor as a neuroprotective treatment for an orphan condition, non-arteritic anterior ischemic optic neuritis (NAION), and for the acute treatment of relapses in multiple sclerosis (MS) patients."

Clinical data • Clinical protocol • Pipeline update • Diabetic Macular Edema • Dry Eye Disease • Multiple Sclerosis • Optic Neuritis

Oculis Completes Enrollment in both DIAMOND Phase 3 Trials of OCS-01 in Diabetic Macular Edema (GlobeNewswire) - "Oculis Holding...today announced that it has completed enrollment in both Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the U.S. Food and Drug Administration (FDA)....Topline data from both Phase 3 trials is expected in the second quarter of 2026, with NDA submission to follow thereafter."

Enrollment closed • P3 data • Diabetic Macular Edema

OCS-01: a Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (clinicaltrials.gov) - P3 | N=241 | Completed | Sponsor: Oculis | Recruiting ➔ Completed

Trial completion • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

LEOPARD: Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects with Uveitis Related and Post Surgical Macular Edema (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Quan Dong Nguyen | Trial completion date: Apr 2025 ➔ Sep 2025 | Trial primary completion date: Jan 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

OPTIMIZE-2: Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery (clinicaltrials.gov) - P3 | N=117 | Terminated | Sponsor: Oculis | Trial completion date: Dec 2024 ➔ May 2024 | Recruiting ➔ Terminated; Sponsor decision to close study due to third-party administrative error preventing analysis of trial results. There was no issue in terms of quality of the investigational product, and no safety risk to any study subject.

Surgery • Trial completion date • Trial termination • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-2) (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Oculis | Trial completion date: Dec 2025 ➔ Jun 2026 | Initiation date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial initiation date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

LEOPARD: Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Quan Dong Nguyen | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Pivotal Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-1) (clinicaltrials.gov) - P2/3 | N=497 | Recruiting | Sponsor: Oculis | Active, not recruiting ➔ Recruiting | Trial completion date: Aug 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment open • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 OPTIREACH® Topical Dexamethasone Eye Drops in Subjects with Diabetic Macular Edema (DME): Efficacy and Safety Findings (ARVO 2024) - "The study successfully met both primary and secondary endpoints in a statistically significant manner. OCS-01 demonstrated strong efficacy and was well-tolerated. Induction with 6 drop/day and maintenance with 3 drops/day was an effective dosing regimen.The positive results support the progression of the DIAMOND program, with two parallel global phase 3 studies."

Clinical • P2/3 data • Diabetic Macular Edema • Ophthalmology

Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2) (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Oculis | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

OPTIMIZE-2: Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Oculis | Not yet recruiting ➔ Recruiting

Enrollment open • Surgery • Trial completion date • Trial initiation date • Trial primary completion date • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain