Layoffs, Rivals, and the Future of Ocular Therapeutix

13% Layoff, Targeting Roche and Regeneron: Can the Once-a-Year Eye Drug Succeed?

Ocular Therapeutix (NASDAQ: OCUL) is a biopharmaceutical company focused on retinal diseases. Leveraging its proprietary biodegradable hydrogel platform ELUTYX, the company aims to provide long-acting treatment options for patients with retinal conditions, including wet AMD (age-related macular degeneration), NPDR (non-proliferative diabetic retinopathy), DME (diabetic macular edema), PDR (proliferative diabetic retinopathy), retinal vein occlusion (RVO), and other ophthalmic indications such as glaucoma.

Ocular boasts a team of world-class retina specialists. Notably, Chief Scientific Officer Dr. Jeffrey Heier has served as a national or international principal investigator in several landmark clinical trials, including a Phase 3 trial of Pegcetacoplan for advanced dry AMD, Phase 3 trials of Aflibercept and Ranibizumab for neovascular AMD, and a Phase 3 trial of dexamethasone implants for RVO.

Biodegradable Hydrogel Technology

Ocular’s proprietary ELUTYX technology is a biodegradable hydrogel matrix designed for sustained, localized drug delivery. Unlike traditional implants, the ELUTYX hydrogel is non-rigid, preservative-free, and highly biocompatible. It forms a mesh-like structure that traps drug particles. During use, the matrix reacts with water to form a hydrated gel, from which the drug particles gradually diffuse into surrounding tissues. After delivery, the hydrogel biodegrades and is cleared from the body without leaving harmful byproducts. Moreover, ELUTYX does not create an acidic microenvironment.

The temperature and pH of the aqueous environment regulate ELUTYX polymer biodegradation. Because human body temperature and the intraocular aqueous humor’s pH are consistent, and intraocular fluids provide enough water to saturate the polymer, the hydrogel degrades at a predictable and repeatable rate. This allows sustained release over days, weeks, or even months. The platform supports both small and large molecule drugs, demonstrating ELUTYX’s safety, flexibility, and efficacy as a drug delivery system.

Products based on ELUTYX technology can be administered via intravitreal injection, anterior chamber injection, or nasal punctal plug insertion.

Reportedly, since hydrogel technology supporting ELUTYX was first used in humans in 1992, it has been proven safe and effective in over 5 million patients through 8 FDA-approved therapies.

Approved Products

Ocular’s approved product DEXTENZA® (dexamethasone ophthalmic insert) is the first and only FDA-approved drug-eluting punctal plug. Commercialized in July 2019, it delivers dexamethasone continuously over 30 days from a non-invasive insertion into the inner eyelid’s punctum. DEXTENZA® dissolves naturally without removal, clearing through the nasolacrimal system. DEXTENZA® is approved in the U.S. and Macau for indications including post-operative ocular inflammation and pain, and ocular itching due to allergic conjunctivitis.

Ocular reports nearly 550,000 eye applications of DEXTENZA® since launch, with an adverse event rate of only about 2 per 10,000 patients — demonstrating strong tolerability of ELUTYX technology. In June 2024, Ocular submitted clinical trial data to the FDA for DEXTENZA® use in treating post-operative inflammation and pain in pediatric cataract surgery. A pediatric labeling decision is expected in Q2 2025.

In October 2020, Ocular partnered with AffaMed Therapeutics to develop and commercialize two products 

— DEXTENZA® and the investigational OTX-TIC (travoprost intraocular implant, also known as PAXTRAVA™) — in Greater China, South Korea, and ASEAN markets.

In February 2024, AffaMed announced that Singapore’s Health Sciences Authority accepted its NDA for DEXTENZA®, for the same indications of post-surgical inflammation and pain, and allergic conjunctivitis-related itching. In October 2023, AffaMed also reported positive real-world data from China on DEXTENZA® in cataract surgery patients — a key milestone for potential approval in mainland China.

Ocular previously had another marketed product, ReSure Sealant, a hydrogel sealant designed to prevent fluid leakage during ophthalmic surgeries involving corneal incisions. It was indicated for managing clear corneal incisions (up to 3.5 mm) in adult cataract surgeries with intraocular lens implantation. However, Ocular no longer manufactures this product.

Additionally, Ocular once collaborated with Regeneron on a sustained-release formulation of Aflibercept. This partnership began as early as 2016 but has since ended.

Promising Pipeline Products

AXPAXLI™ (Axitinib intravitreal implant, also known as OTX-TKI) is currently Ocular’s most prominent retinal disease candidate, developed using its proprietary ELUTYX hydrogel technology. The active ingredient, axitinib, is a small molecule, multi-target tyrosine kinase inhibitor (TKI) with high selectivity for VEGFR-1, VEGFR-2, and VEGFR-3. It is already approved for the treatment of renal cell carcinoma. Ocular is developing AXPAXLI™ for the treatment of wet AMD (age-related macular degeneration), DR (diabetic retinopathy), and other retinal diseases.

Wet AMD is the most common cause of vision loss in people over 50 in developed countries. In 2024, about 1.7 million people in the U.S. were affected by wet AMD. The current standard treatment involves anti-VEGF drugs administered via intravitreal injection, but frequent injections reduce patient compliance — a major drawback. From Lucentis (ranibizumab) to Eylea (aflibercept) to the dual-target VEGF-A/Ang-2 drug Vabysmo (faricimab), injection intervals have gradually improved. Ocular aims to extend the injection interval of AXPAXLI™ to once every 6 to 12 months.

According to company slides, a U.S.-based Phase 1 proof-of-concept study in wet AMD showed that 100% of patients receiving a single AXPAXLI™ injection required no retreatment within 6 months, and 80% required none within 10 months. A separate Phase 1 study in Australia also demonstrated monotherapy activity in treatment-naïve wet AMD patients.

Two pivotal Phase 3 clinical trials, SOL-1 and SOL-R, are currently underway and progressing ahead of schedule. SOL-1 is a superiority study comparing a single optimized dose of AXPAXLI™ (450 µg axitinib) versus a single 2 mg aflibercept injection, assessing safety and efficacy in wet AMD patients. The SOL-1 trial design was revised twice following FDA consultations and completed enrollment of 344 subjects in December 2024. Topline results are expected in Q1 2026.

SOL-R is a non-inferiority study with the primary endpoint being the non-inferiority of best-corrected visual acuity (BCVA) change from baseline at Week 56 between the AXPAXLI™ group and standard-label 2 mg aflibercept. As of January 10, 2025, 311 subjects had been enrolled. If both trials yield positive outcomes, Ocular plans to submit a New Drug Application (NDA) under section 505(b)(2) of the U.S. FDCA.

AXPAXLI™ is also being studied for diabetic retinopathy (DR), which represents a large unmet need. DR is a leading cause of vision loss among the working-age population. There are approximately 8.8 million DR patients in the U.S., 72% of whom have NPDR (non-proliferative diabetic retinopathy), yet only 1% of NPDR patients receive treatment.

A Phase 1 trial named HELIOS is evaluating a single 600 µg injection of AXPAXLI™ in moderate-to-severe NPDR patients. In June 2024, Ocular announced topline results: 37.5% (3/8) of patients in the control group progressed to PDR (proliferative diabetic retinopathy) or CI-DME (center-involved diabetic macular edema), compared to 0% in the AXPAXLI™ group. Furthermore, 46.2% (6/13) of AXPAXLI™-treated patients had a 1- or 2-step improvement in DR severity (DRSS), with 23.1% (3/13) achieving a 2-step improvement.

Ocular plans to discuss potential registration trials for AXPAXLI™ in NPDR and DME (diabetic macular edema) with the FDA in the first half of 2025, with next steps to be determined thereafter.

The company estimates that AXPAXLI™ could serve a U.S. patient population of approximately 9.2 million across indications including wAMD, DME, NPDR, PDR, and RVO (retinal vein occlusion).

Another pipeline candidate is PAXTRAVA™ (travoprost intraocular implant, development code OTX-TIC), currently in Phase 2 trials evaluating its safety, tolerability, and efficacy in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT). Travoprost is a prostaglandin analog (PGA) commonly used in eye drops to reduce intraocular pressure by increasing aqueous humor outflow. However, the need for frequent eye drop use leads to poor adherence and suboptimal outcomes.

PAXTRAVA™ is designed for intracameral injection, targeting a sustained drug release over 4–6 months with a single treatment.

Ocular also has two dry eye programs: OTX-DED (dexamethasone punctal plug) for short-term relief of dry eye signs and symptoms, and OTX-CSI (cyclosporine punctal plug) for chronic treatment. However, both are currently not under active development.

2024 Operational Overview

Ocular’s current revenue is primarily driven by DEXTENZA®. In 2024, total revenue reached $63.72 million, a 9% year-over-year increase, mainly from DEXTENZA® sales ($63.46 million), plus $260,000 from a collaboration with AffaMed Therapeutics.

Total R&D expenses were $127.6 million in 2024 (up from $61.1 million in the previous year), mainly due to clinical trial activities. Sales and marketing expenses totaled $41.6 million (up from $40.5 million), and general and administrative expenses were $60.7 million (up from $33.9 million). The company posted a net loss of $193.5 million for the year.

In May 2024, Ocular’s board approved a strategic layoff plan to cut 37 full-time employees, primarily from R&D and technical operations — approximately 13% of its total workforce. This move aims to prioritize clinical development of AXPAXLI™ for wet AMD. The related severance and termination costs amounted to $1.6 million.

In February 2024, Ocular also completed a private equity financing, raising net proceeds of approximately $316.4 million.

As of the end of 2024, Ocular held $392.1 million in cash and cash equivalents, expected to fund operations through 2028. As of March 18, 2025, the company had a market capitalization of $1.185 billion.