GlobalData has identified a critical need for treatments that can reduce the burden imposed by the high frequency of administration. Credit: Shutterstock

Ocular Therapeutix is preparing to launch a pivotal trial of OTX-TKI in wet age related macular degeneration (AMD) after announcing positive topline Phase I results.

Ocular reported 12-month data from its 21-patient Phase I trial (NCT04989699) showing OTX-TKI maintained vision comparable to Regeneron Pharmaceuticals’ Eylea (aflibercept). The company now plans to initiate a pivotal trial as soon as Q3 2023, depending on financing that could take the form of a strategic alliance.

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The Phase I trial is evaluating a dose of OTX-TKI in a single implant followed by an Eylea injection four weeks after the implant, compared to Eylea injections administered every eight weeks. Overall, an 89% reduction in treatment burden was observed in OTX-TKI treated subjects at 12 months.

While Eylea has is standard of care among anti vascular endothelial growth factor (VEGF) therapies, GlobalData has identified a critical need for treatments that can reduce the burden imposed by the high frequency of administration. According to GlobalData, the global market for AMD is expected to grow from $9.2 billion in 2021 to more than $30.2 billion in 2031.

GlobalData is the parent company of Clinical Trials Arena.

OTX-TKI is a bioresorbable hydrogel intravitreal implant that continuously delivers a selective inhibitor of VEGF receptor tyrosine kinase, axitinib. The drug is marketed by Pfizer  under the brand name Inlyta.

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As of the data cut-off of April 14, 2023, there were no drug-related ocular or systemic serious adverse events (SAEs) observed in the OTX-TKI arm.

Ocular’s Phase I data of OTX-TKI

The US-based Phase I clinical trial was a prospective, multi-centre, randomized, controlled study in subjects previously treated with anti-VEGF therapy. The primary endpoint was safety, with secondary endpoints including best corrected visual acuity (BCVA) and central subfield thickness (CSFT) of the retina.

The results showed subjects treated with a single OTX-TKI implant continued to demonstrate sustained BCVA (mean change from baseline of -1.0 letters) and CSFT (mean change from baseline of +20.2 μm) in the OTX-TKI arm at 12 months. This was comparable with the Eylea arm (mean change from BCVA baseline of +2.0 letters; mean change from CSFT baseline of -2.2 μm).

“Pharmacodynamic effects observed in this trial support the characteristics of a treatment for wet AMD with durability between 9 to 12 months with a single injection. Following discussions with the FDA, we have two potential pivotal designs and are prepared to initiate a first pivotal trial for OTX-TKI in wet AMD as early as the third quarter of this year.” said Antony Mattessich, CEO of Ocular Therapeutix.

OTX-TKI is also being investigated for the treatment of diabetic retinopathy and other retinal diseases. The company has completed enrolment of the Phase I HELIOS clinical trial (NCT05695417) to evaluate OTX-TKI for the treatment of diabetic retinopathy.