Daily Newsletter

13 June 2023

Daily Newsletter

13 June 2023

Ocular Therapeutix gears up for pivotal trial in wet AMD

Ocular plans to launch a pivotal trial of OTX-TKI based on positive Phase I results with the implant in wet AMD.

Phalguni Deswal June 12 2023

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.

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.

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.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close