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

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

Pharmacodynamic efficacy of second-generation intravitreal axitinib implant (Axpaxli™) in a VEGF challenge rabbit model (ARVO 2024) - "Gen2 450 µg axitinib intravitreal implant showed a sustained pharmacodynamic effect for at least 73 days, surpassing the duration of bevacizumab's effectiveness. These findings up to 73 days demonstrate axitinib intravitreal implant's steady inhibition of VEGF activity through repeat challenges and potential to continuously control retinal vascular diseases. We anticipate reporting additional results from this ongoing study."

Clinical • PK/PD data • Preclinical • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • GEN1

Optimized pharmacokinetic profile of intravitreal axitinib intravitreal implant (Axpaxli™): a comparison of first- and second-generation implants (ARVO 2024) - "Gen2 intravitreal axitinib implants achieved higher initial axitinib concentrations rapidly in the target tissues and maintained steady state concentrations without spikes as observed with the Gen1 implants, indicating improved synchronization of drug release with hydrogel bioresorption. These findings highlight the promising pharmacokinetic profile of Gen2 axitinib implants in treating retinal vascular diseases."

PK/PD data • Ophthalmology • Wet Age-related Macular Degeneration • GEN1

Long-term safety of repeated intravitreal axitinib implant (Axpaxli™) administrations in non-human primates (ARVO 2024) - "Repeated intravitreal administration of axitinib implants in a nonclinical primate model was observed to be generally well-tolerated over an 18-month period. This study establishes the no observed adverse effect level for the axitinib implant at two 700µg implants (1400 µg). These findings reinforce the sustained release of axitinib from an intravitreal implant as a potential therapeutic option for the treatment of retinal vascular diseases."

Clinical • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • GEN1

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=300 | 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

Ocular Therapeutix Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI in Wet AMD (GlobeNewswire) - "Ocular Therapeutix, Inc...announced that the first three subjects have been screened and received their first aflibercept injection in the Phase 3 SOL-1 clinical trial of AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD). The Company previously announced FDA agreement on its Special Protocol Assessment (SPA) Agreement Modification on January 25th."

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

Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Ocular Therapeutix, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2023 ➔ Dec 2023

Trial completion • Trial 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 (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Ocular Therapeutix, Inc.

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