2023-06-12 15:01:57 ET
Ocular Therapeutix ( NASDAQ: OCUL ) lost ~9% on Monday after announcing 12-month data from its Phase 1 clinical trial for eye implant OTX-TKI in patients with wet age-related macular degeneration (wet AMD), a leading cause of blindness.
Citing data as of Apr. 14, the company said that the intravitreal implant, designed to deliver the tyrosine kinase inhibitor axitinib, indicated an 89% reduction in treatment burden over 12 months.
The 12-patient U.S. trial tested aflibercept, a VEGF inhibitor marketed by Regeneron’s ( REGN ) as Eylea, against a single implant of OTX-TKI plus aflibercept injection administered four weeks after the implant.
According to its results, OTX-TKI indicated durable biological activity comparable with the aflibercept arm in terms of corrected visual acuity (BCVA) and central subfield thickness (CSFT) of the retina.
Four subjects received rescue therapy for the first time at Month 12, and there were no serious drug-related ocular or systemic adverse events, the company said.
Ocular ( OCUL ) intends to start a pivotal trial for OTX-TKI in wet AMD in Q3 2023, subject to required funding, which it expects to secure through a partnership.
More on Ocular
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Ocular falls after 12-month data for wet AMD candidate