• Organizations: Ocular Therapeutix
Ocular Therapeutix releases additional phase 3 AXPAXLI data for wet AMD
Pipeline

Ocular Therapeutix releases additional phase 3 AXPAXLI data for wet AMD

Data from SOL-1 phase 3 data will become the basis of a planned NDA submission in near future.
Ocular Therapeutix plans for NDA submission of AXPAXLI for wet AMD
Pipeline

Ocular Therapeutix plans for NDA submission of AXPAXLI for wet AMD

Company expects to submit package in Q1 2026, following the anticipated release of positive 1-year data from the phase 3 SOL-1 trial.
FDA agrees to SPA for Ocular Therapeutix NPDR registrational trial
Pipeline

FDA agrees to SPA for Ocular Therapeutix NPDR registrational trial

Agreement includes planned design for study evaluating AXPAXLI (formerly OTX-TIKI), an IVT implant with the potential for long-term durability and fewer injections.
First patients enrolled in Ocular Therapeutix phase 3 wet AMD study
Pipeline

First patients enrolled in Ocular Therapeutix phase 3 wet AMD study

New SOL-R trial intends to provide real-world evidence supporting the potential for axitinib intravitreal implant redosing every 6 months.
Ocular Therapeutix releases positive NPDR phase 1 data, plans for wet AMD repeat dosing study
Pipeline

Ocular Therapeutix releases positive NPDR phase 1 data, plans for wet AMD repeat dosing study

Updates follow company’s decision to cut 13% of workforce in order to focus on the clinical development of axitinib intravitreal implant.
Ocular Therapeutix to cut 13% of workforce
Business

Ocular Therapeutix to cut 13% of workforce

Company cites new initiative to prioritize clinical development of its axitinib intravitreal implant for wet AMD, currently in a phase 3 trial.
Ocular Therapeutix announces executive chairman as new CEO
Business

Ocular Therapeutix announces executive chairman as new CEO

Effective immediately, Pravin U. Dugel, MD, will also take over as president.
FDA amends SPA for Ocular Therapeutix phase 3 wet AMD trial
Pipeline

FDA amends SPA for Ocular Therapeutix phase 3 wet AMD trial

Modification allows the company to accelerate the enrollment process for the SOL trial.
Ocular Therapeutix initiates first pivotal trial of implant for wet AMD
Pipeline

Ocular Therapeutix initiates first pivotal trial of implant for wet AMD

OTX-TKI offers the potential for long-term durability with fewer injections.
Enrollment completed for Ocular Therapeutix's HELIOS trial in DR
Research

Enrollment completed for Ocular Therapeutix's HELIOS trial in DR

OTX-TKI has the potential to offer long-term durability and a reduced need for frequent, invasive injections.
Ocular Therapeutix releases 12-month topline data from phase 1 wet AMD trial
Pipeline

Ocular Therapeutix releases 12-month topline data from phase 1 wet AMD trial

Efficacy of OTX-TKI could potentially extend beyond three to four months with a single injection.
Interim data announced for Ocular Therapeutix phase 1 trial on wet AMD
Pipeline

Interim data announced for Ocular Therapeutix phase 1 trial on wet AMD

Ongoing study of 10-month data of OTX-TKI shows well tolerance, no SAEs.