Axpaxli (intravitreal axitinib implant) / Ocular Therapeutix - LARVOL DELTA

Ocular Therapeutix Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI in Wet AMD (The Manila Times) - "...the Company now intends to submit a New Drug Application (NDA) for AXPAXLI (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026...The Company expects that additional data from the continuation of SOL-1 in year two, SOL-R, and SOL-X will help clinicians and payors appreciate the anticipated benefits of AXPAXLI's efficacy, safety, and durability, allowing them to seamlessly adopt AXPAXLI into clinical practice."

FDA filing • P3 data • Wet Age-related Macular Degeneration

Ocular Therapeutix…announced Friday that it intends to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate AXPAXLI (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) (Investing.com) - "The company plans to base the application on year 1 data from its ongoing SOL-1 Phase 3 clinical trial, according to a press release statement and a filing with the Securities and Exchange Commission....The company expects to report top-line data from the first year of the SOL-1 clinical trial during the first quarter of 2026."

FDA filing • P3 data: top line • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces First Patient Randomized in HELIOS-3 Phase 3 Registrational Program for AXPAXLI in NPDR (GlobeNewswire) - "The registrational Phase 3 HELIOS-3 trial...will be the second superiority study of AXPAXLI in approximately 930 subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME)."

Trial status • Diabetic Retinopathy

HELIOS-3: A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy (clinicaltrials.gov) - P3 | N=930 | Recruiting | Sponsor: Ocular Therapeutix, Inc.

New P3 trial • Diabetic Retinopathy • Retinal Disorders

Ocular Therapeutix Achieves Target Randomization of 555 Subjects in SOL-R (GlobeNewswire) - "Ocular will continue to allow randomization of previously enrolled subjects currently in the loading phase of the trial to maintain its commitment to both patients and investigators, with topline data remaining on track for the first half of 2027."

Enrollment status • P3 data: top line • Wet Age-related Macular Degeneration

Ocular Therapeutix to present at Clinical Trials at the Summit 2025 (Modern Retina) - "At the meeting, the company will participate in several discussions and presentations as they share their ongoing work in developing tyrosine kinase inhibitor (TKI) candidates for the treatment of several retinal diseases, including wet age-related macular degeneration (AMD) and diabetic retinopathy (DR)."

Clinical data • Diabetic Retinopathy • Wet Age-related Macular Degeneration

OTX-TKI-2023-AMD-303: Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration (clinicaltrials.gov) - P3 | N=825 | Active, not recruiting | Sponsor: Ocular Therapeutix, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ocular Therapeutix Reports First Quarter 2025 Results and Business Highlights (GlobeNewswire) - "SOL-R (Phase 3, wet AMD) enrollment continues to be strong following the recent reduction in target randomization to approximately 555 subjects (previously 825)....Streamlining the execution of SOL-R is expected to accelerate the trial readout and, if successful, the AXPAXLI wet AMD NDA submission timeline....Written feedback received from FDA on AXPAXLI registrational trial in non-proliferative diabetic retinopathy (NPDR). The FDA provided positive feedback to Ocular on a potential registrational trial design for AXPAXLI in NPDR. Following recent changes more broadly within the FDA, Ocular has not noticed any disruption in the cadence and nature of its dialogue with the Agency to date and continues to maintain productive interactions. The Company is actively planning next steps in the development of AXPAXLI for NPDR and diabetic macular edema (DME) and expects to provide further details at a later date."

FDA event • Trial status • Age-related Macular Degeneration • Diabetic Retinopathy

Ocular Therapeutix Reports First Quarter 2025 Results and Business Highlights (GlobeNewswire) - "SOL-1 (Phase 3, wet AMD) retention remains exceptional and the vast majority of rescues, evaluated on a masked basis, continue to be per protocol. Topline data are on track for 1Q 2026. In March, the Company announced that the FDA accepted an amendment to the SOL-1 Special Protocol Assessment (SPA) agreement that includes re-dosing of all subjects at Weeks 52 and 76 with their respective initial treatment of AXPAXLI or aflibercept (2 mg). Subjects will remain masked and are then followed for safety until the end of year two."

Clinical protocol • P3 data: top line • Age-related Macular Degeneration

Target and selectivity profiling of axitinib in cell-based and biochemical assays (ARVO 2025) - "Additionally, cell-based and radiometric kinase assays (33PanQinaseTM) were conducted at Reaction Biology, Germany, to evaluate half-maximal inhibitory concentration (IC50) of axitinib and vorolanib on VEGFR, PDGFR, FGFR, and TIE2 kinase activity with sunitinib as positive control. 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."

Ophthalmology • FGFR • FLT1 • FLT4 • KDR • PDGFRA • PDGFRB

OTX-TKI-2023-AMD-301: Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (axitinib Implant) in Subjects with Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=344 | Active, not recruiting | Sponsor: Ocular Therapeutix, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces Upcoming Presentations at the Angiogenesis, Exudation, and Degeneration 2025 Virtual Meeting (GlobeNewswire) - "Ocular Therapeutix...today announced upcoming presentations at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting on February 8, 2025."

P1 data • P3 data • Age-related Macular Degeneration • Diabetic Retinopathy

Ocular Therapeutix Shares SOL-R Enrollment Progress and Next Steps for AXPAXLI in NPDR (GlobeNewswire) - "311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI in wet AMD, as of January 10, 2024; First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025; Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR."

FDA event • Trial status • Age-related Macular Degeneration

OTX-TKI-2023-AMD-303: Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration (clinicaltrials.gov) - P3 | N=825 | Recruiting | Sponsor: Ocular Therapeutix, Inc. | Initiation date: Jul 2024 ➔ Nov 2024

Trial initiation date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces More Than 300 Subjects Randomized in SOL-1 (GlobeNewswire) - "Ocular Therapeutix, Inc...announced that more than 300 patients have been randomized in the SOL-1 Phase 3 trial for AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI), and the trial is expected to close randomization this week. This is the first registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD), which remains on track to report topline data in the fourth quarter of 2025."

P3 data • Trial status • Age-related Macular Degeneration • Ophthalmology

Ocular Therapeutix to Participate in December Investor and Scientific Conferences (GlobeNewswire) - "Ocular Therapeutix, Inc...announced participation in several investor and scientific conferences being held in December."

P1 data • Diabetic Retinopathy • Ophthalmology

Ocular Therapeutix Announces Accelerated Timelines for SOL-1 Registrational Trial of AXPAXLI in Wet AMD (GlobeNewswire) - "Ocular Therapeutix, Inc...announced accelerated timelines for the SOL-1 Phase 3 registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD). The Company now expects the SOL-1 study to be fully enrolled with all patients randomized by the end of 2024. This is meaningfully ahead of prior guidance to complete enrollment by the end of the first quarter of 2025. With this update, topline data from the SOL-1 trial are now expected during the fourth quarter of 2025."

Enrollment status • P3 data: top line • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces FDA Feedback That SOL-R Trial is Appropriate as a Registrational Study in Wet AMD (Ocular Therapeutix Press Release) - "Ocular Therapeutix, Inc...announced that the Company has received a written response from the U.S. Food and Drug Administration (FDA) that the Phase 3 SOL-R clinical trial is appropriate for use as the Company’s second adequate and well controlled study of AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD)."

Trial status • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Ocular Therapeutix Reports Second Quarter 2024 Results (GlobeNewswire) - "Ocular Therapeutix, Inc...today reported financial results for the second quarter ended June 30, 2024 and provided recent business highlights, including an update on the Phase 3 AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) wet age-related macular degeneration (wet AMD) program....Research and development expenses for the second quarter of 2024 were $28.9 million versus $15.1 million for the comparable period in 2023, reflecting an increase in overall clinical expenses associated with product development programs, specifically the ongoing enrollment in the SOL-1 Phase 3 clinical trial, and the design and initiation of start-up activities in the SOL-R Phase 3 clinical trial, as well as additional personnel and professional services to support these clinical trials."

Commercial • Trial status • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces First Patients Enrolled in Phase 3 SOL-R Wet AMD Study (GlobeNewswire) - "Ocular Therapeutix, Inc...announced that the first patients have been enrolled in the Phase 3 SOL-R clinical trial evaluating repeat dosing of AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD). SOL-R is a global, 825-patient, non-inferiority study evaluating repeat dosing of AXPAXLI every six months (Q6M) compared to 2 mg aflibercept, dosed every eight weeks (Q8W) in patients with wet AMD."

Trial status • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration (clinicaltrials.gov) - P3 | N=825 | Recruiting | Sponsor: Ocular Therapeutix, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

CLN-0046: Treatment of AMD Subjects With OTX-TKI (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Ocular Therapeutix, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jan 2024 | Trial primary completion date: Dec 2022 ➔ Jan 2024

Trial completion • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration (clinicaltrials.gov) - P3 | N=825 | Not yet recruiting | Sponsor: Ocular Therapeutix, Inc.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ocular Therapeutix Announces Late-Breaking Abstract of HELIOS Study to be Presented at 42nd ASRS Annual Scientific Meeting (GlobeNewswire) - "Ocular Therapeutix, Inc...announced that a late-breaking abstract related to the Phase 1 HELIOS study of AXPAXLI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy (NPDR) was accepted for presentation at the 42nd American Society of Retina Specialists (ASRS) Annual Scientific Meeting being held July 17-20 in Stockholm, Sweden."

Late-breaking abstract • P1 data • Diabetic Retinopathy • Ophthalmology

Ocular Therapeutix to Host Investor Day on June 13, 2024 (GlobeNewswire) - "Ocular Therapeutix, Inc...will host an Investor Day on Thursday, June 13, 2024. The in-person event with virtual access will begin at 2:00 PM ET....A review of Ocular’s clinical program for AXPAXLI in the treatment of wet AMD, including a progress update for the ongoing SOL-1 study; and An update and discussion of the Phase 1 HELIOS data for AXPAXLI in non-proliferative diabetic retinopathy (NPDR)."

P1 data • Trial status • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration