Clearside Biomedical, Inc. has reached a crossroads in the advancement of its suprachoroidal space (SCS) delivery platform, with the company announcing plans to explore alternative strategic alternatives for fundraising amidst a challenging economic climate.
Let’s start with a look at this company.
Headquartered in Alpharetta, Georgia, Clearside is a biopharmaceutical company focused exclusively on an SCS approach to target retinal disease by delivering therapeutics directly to the macula, retina, or choroid.
- The intent: To (potentially) preserve and even improve vision in patients diagnosed with sight-threatening ocular diseases.
And how is Clearside working toward this goal?
Via two specific approaches:
- Developing a pipeline of small-molecule product candidates for delivery into the SSC
- Its first product: XIPERE (triamcinolone acetonide injectable suspension) was FDA approved in 2021 for macular edema associated with uveitis; Bausch + Lomb owns the North American exclusive licensing and commercialization rights
- Currently under clinical investigation: CLS-AX (axitinib injectable suspension) for wet age-related macular degeneration (AMD)
- Delivering these products / candidates via a proprietary SCS delivery system: the SCS Microinjector
Tell me more about this SCS delivery platform.
The proprietary SCS injection treatment approach provides an in-office, repeatable, and nonsurgical procedure featuring a patent-protected technology injection platform designed as a microneedle device.
Its purpose: To provide a targeted delivery of drugs (such as XIPERE and CLS-AX) into the SCS to reduce or eliminate potential toxic effects—ideally allowing a more flexible dosing schedule for long-term maintenance.
- The intent: A reduction or even elimination of potential toxic effects (via this SCS delivery) often associated with anti-vascular endothelial growth factor (VEGF) drugs.
And its regulatory status?
The SCS Microinjector is currently only cleared by the FDA for its specific drug-device use with (delivery of) XIPERE; the system has not yet received FDA approval as a standalone device.
- Outside the U.S.: The system is approved and commercialized for use with XIPERE in Australia and Singapore, and is currently under regulatory review in China and Canada.
- Plus: Clearside reported partnerships with several companies (including Bausch + Lomb and REGENXBIO) to license its SCS technology for delivery of their own ophthalmic disease-targeted therapeutics.
Also noteworthy: A permanent CPT code in the U.S. was assigned for suprachoroidal injections in 2023, enabling higher reimbursements for physicians administering drugs into the SCS.
Nice! So where is the company directing its clinical efforts now?
That would be CLS-AX, its latest investigational SCS therapy.
What it is: A proprietary suspension of axitinib—a highly potent tyrosine kinase inhibitor (TKI), to be exact—intended for suprachoroidal injection as a longer-acting therapy for retinal disease detachment (wet AMD).
- Check out how its pan-VEGF inhibition works (also keep in mind: CLS-AX is delivered via the SCS Microinjector)
What's the clinical data thus far?
CLS-AX was most recently evaluated in the phase 2b ODYSSEY trial (NCT05891548)—with promising results (see here for our coverage).
- Per Clearside President and CEO George Lasezkay, PharmD, JD, this is “the only TKI clinical trial to date to achieve positive safety and efficacy results from multiple TKI dosing in wet AMD patients.”
And what’s the plan moving forward?
Clearside met with the FDA earlier this year for an end-of-phase 2 meeting, which the company referred to as “successful” and ended with both parties “aligned on the essential components of a phase 3 program” for CLS-AX.
More about these phase 3 plans: The reported intent is to “maximize the commercial potential” for the wet AMD candidate in enabling “dosing flexibility similar to the current standard of care anti-VEGF biologics”—but with the extended durability associated with that of TKIs.
Is there a timeframe for launching this program?
None so far. However, we do know that it will include two identical non-inferiority trials.
The company did, however, share its next steps in navigating “the current unpredictable economic environment and challenging fundraising conditions” within the biopharma industry.
And those steps include … ?
In a move to “evaluate strategic alternatives,” the company has hired a biotech industry-focused investment bank as part of the process for advancing the SCS microinjection system.
Among the options it’s looking at to maximize shareholder value:
- Sales
- Licensing
- Merger
What other measures have been taken?
The company’s CEO shared that all internal research and development programs have been paused.
And in an effort to conserve its cash, Clearside’s employees (including executive leadership) have reportedly transitioned into consulting roles.
- In general: A consulting role at biopharma companies typically involves providing expert advice on specific projects or challenges to assist in making informed decisions, improving operations, and achieving corporate goals.
In this case: The move can also help the company by:
- Reducing its overhead to avoid the costs that come with employing full-time staff
- Enabling flexibility for the business to scale up or down based on its evolving needs
So when might the company make a decision on next steps?
That’s currently up in the air at the moment.
As Clearside noted, it has set “no timetable for the strategic review process,” and there is also no assurance that the process “will result in any transaction.”
As always, stay tuned for more development on this (including that phase 3 program) in the near future!