Fresh off of naming its newest CEO, Ocular Therapeutix, Inc. is expected to eliminate 13% of its full-time employee workforce, according to a recent U.S. Securities and Exchange Commission (SEC) filing.
Let’s start with the big question: Why?
The company noted that the layoffs—approved by its Board of Directors—are part of an initiative to prioritize resources on the clinical development of its wet age-related macular degeneration (AMD) therapeutic: AXPAXLI (axitinib intravitreal implant).
More about that implant in a moment …
What positions do these include?
The layoffs are reported to be primarily within the company’s research and development and technological operations sectors.
In total: 37 positions will be eliminated.
Further: Ocular Therapeutix told Glance that the company has retained the "critical R&D members responsible for any further development of AXPAXLI."
And when will this be effective?
Both the workforce reduction and record relating to its restructuring changes are expected by Q2 2024.
Also by this time, Ocular Therapeutix plans to incur total restructuring costs of an estimated $1 to $2 million, which will include the following (and is expected to lead to cash expenditures by Q2 and Q3 2024):
- Garden leave
- Where an employee leaving a job is asked to stay away from work after resigning or being terminated, all while still receiving pay and benefits
- Severance benefits
- Other related costs
Note: The company also noted that it’s currently unable to afford additional restructuring costs/charges at the moment but will amend its SEC filing if it later determines any incurring of additional significant costs/charges.
Go on ...
The company added that the focus remains on positioning Ocular Therapeutix for sustainable growth and success—"We believe these difficult decisions will help us achieve that goal," the company said.
For additional information regarding Ocular Therapeutix’s new strategic priorities, the company is hosting an Investor Day on June 13.
Yikes. Now let’s circle back to this candidate they’re focusing on.
AXPAXLI (also known as OTX-TKI) is an investigational, bioresorbable hydrogel intravitreal implant with anti-angiogenic properties.
Its purpose: to continuously deliver axitinib (a small-molecule, multi-target tyrosine kinase inhibitor [TKI]) for wet AMD.
Potential indications currently in development for:
- Diabetic retinopathy (DR) (for details on the phase 1 HELIOS trial, click here and see here for topline data).
- Other vascular endothelial growth factor (VEGF)-mediated retinal diseases
- Wet AMD
And how is this implant delivered?
The intravitreal implant is being designed to deliver axitinib using Ocular Therapeutix’s proprietary ELUTYX technology platform—a bioresorbable polymer matrix hydrogel developed to provide localized, sustained-release drug delivery.
- The duration: AXPAXLI is administered via a 25G needle, with a target release of 9 to 12 months
- The goal: to facilitate targeted drug delivery and minimize systemic exposure (per the company)
And what’s the clinical data on it so far?
Ocular Therapeutix reported phase 1 data (NCT04989699) in June 2023.
Those findings: AXPAXLI demonstrated promising safety and durability when compared to aflibercept injections, delivering efficacy that extends beyond 3 to 4 months with a single implant. Details here.
Nice! So what’s next?
In January 2024, the FDA agreed to modify a Special Protocol Assessment (SPA) for the company’s ongoing pivotal phase 3 trial (initiated in October 2023).
Before we get to this SPA, talk about the study.
The multicenter, double-masked, randomized, parallel-group, pivotal phase 3 SOL trial (NCT06223958) is recruiting an estimated 300 patients (aged 50+) with wet AMD who are treatment naïve in the study eye.
The setup: Participants will randomly receive either one injection of aflibercept or one AXPAXLI implant followed by an as-needed supplemental anti-VEGF treatment.
The measurements:
- Best-corrected visual acuity (BCVA) up to 36 weeks
- Incidence and severity of treatment-emergent adverse events (TEAEs) up to 104 weeks
Now the modification.
The FDA’s SPA modification agreement allows for the following:
- Inclusion of treatment-naïve wet AMD patients with a visual acuity (VA) of approximately 20/80 or better at their initial screening visit
- Study may evaluate AXPAXLI with a single optimized configuration containing a drug load of 450 µg of a more soluble form of axitinib
- After two aflibercept injections in the screening period, eligible participants must achieve one of the following criteria to qualify for trial enrollment (in addition to meeting other participant criteria):
- Gain at least 10 [Early Treatment Diabetic Retinopathy Study] ETDRS letters from the initial screening visit to Day 1, or
- Achieve a VA of approximately 20/20 or better at Day 1
And the reasoning for these modifications?
In the words of CEO Antony Mattessich, the intent is to “accelerate the enrolment process for the SOL trial.”
Lastly … when might we see topline data from this study?
With Clinical Trials estimating a completion date of September 2027, likely not for some time …
As always, stay tuned!