Ocular Therapeutix, Inc. (NASDAQ: OCUL), a leading biopharmaceutical company specializing in innovative eye disease therapies, recently announced its financial results for the second quarter ending on June 30, 2023. Alongside impressive financial performance, the company provided updates on its burgeoning ophthalmology pipeline, showcasing remarkable progress in research and development.
Financial Success and Growth
Antony Mattessich, President and CEO of Ocular Therapeutix, shared the company’s achievements and vision, stating, “The progress at Ocular Therapeutix over this last quarter has been significant.” He emphasized that the company had achieved $15.0 million in net product revenues from DEXTENZA for the quarter, representing a 24% growth compared to the same quarter last year and a 14% increase from the previous quarter. This marks the third consecutive quarter of sequential growth in in-market unit sales.
The strong performance of DEXTENZA not only reflects its commercial success but also signifies its potential to support the company’s growing pipeline. Moreover, Ocular Therapeutix secured an $82.5 million credit facility, ensuring funding for upcoming pivotal trials and extending its financial runway into 2025.
Advancing Promising Treatments
Ocular Therapeutix is making significant strides in the development of OTX-TKI, an axitinib intravitreal implant, for the treatment of wet AMD (Age-Related Macular Degeneration) and other retinal vascular diseases. The company presented positive 12-month top-line data from its Phase 1 trial of OTX-TKI, conducted with 21 subjects in the United States.
Key highlights from the Phase 1 trial results include:
- Reduced Treatment Burden: OTX-TKI demonstrated an impressive 89% reduction in treatment burden for up to 12 months, offering potential benefits for patients.
- Sustained Vision and Thickness: Subjects receiving a single OTX-TKI implant continued to exhibit sustained Best Corrected Visual Acuity (BCVA) and Central Subfield Thickness (CSFT) at 12 months, comparable to the results in the aflibercept arm of the study.
- Rescue-Free Period: Notably, 60% of OTX-TKI subjects remained rescue-free up to Month 12, with only a few requiring rescue therapy. This finding helps establish a re-dosing timeline for patients.
- Safety Profile: The data revealed that a single OTX-TKI implant was well-tolerated, with no drug-related ocular or systemic serious adverse events (SAEs) observed through Month 12.
The company’s plans for OTX-TKI include initiating the first of two pivotal trials for wet AMD in Q3 2023. This prospective, multi-center, randomized trial will enroll approximately 300 treatment-naïve wet AMD subjects in the study eye, comparing OTX-TKI to aflibercept. The trial will assess safety and efficacy by measuring BCVA and CSFT, aligning with FDA guidelines.
Additionally, Ocular Therapeutix is making strides in the treatment of non-proliferative diabetic retinopathy (NPDR) with OTX-TKI. The company completed enrollment of the HELIOS trial in June 2023 and plans to present interim 6-month data in Q1 2024. Pending positive interim data and securing necessary financing, Ocular Therapeutix aims to initiate a Phase 3 pivotal trial for NPDR as early as Q1 2024.
These achievements reflect Ocular Therapeutix’s commitment to advancing eye disease therapies and improving the lives of patients. The company’s financial success, coupled with promising clinical developments, positions it for a bright future in the field of ophthalmology.
