Pykus Therapeutics, Inc. announced the completion of participant enrollment for a pilot study evaluating the use of PYK-2101, a retinal sealant, in patients receiving vitreoretinal surgery.
First, a rundown on Pykus.
Founded in 2016 and headquartered in Cambridge, Massachusetts, the clinical-stage medical technology company is developing treatments and solutions for ophthalmic diseases—with a particular focus on retinal diseases.
Its current focus: Developing biodegradable polymers to fulfill unmet needs in vitreoretinal surgery.
- Key to this: The company is utilizing technology stemming from Harvard Medical School’s Mass Eye and Ear.
And PYK-2101?
As Pykus’s lead investigational product candidate, PYK-2101 is a biodegradable, focal hydrogel retinal sealant intended for use in patients undergoing surgery for retinal detachment.
Its role: To replace the need for special types of medical gases and silicone oils that are often used at the end of surgery and left in the eye to seal—or, more accurately, ”tamponade”—the retinal surface.
- To note: In retinal surgery, tamponade involves using a temporary or permanent agent (those aforementioned gases and oils) to hold the retina in place and enable reattachment following a retinal detachment.
Real quick: Why replace this?
While both gas and silicone oil are commonly used with tamponades for retinal surgery—resulting in comparable anatomic and visual outcomes—Pykus identified a few key limitations associated with their use.
When using a gas: Patients are required to posture (lay face down) “for days to weeks” post-surgery, are unable to see clearly while the gas is still in their eye—which can range from a few weeks to months—and, on top of that, aren’t able to fly until the gas is completely gone.
- Plus: “The gas is poorly effective when the retinal problem is in the inferior half of the retina,” Pykus noted.
And with silicone oil: This is typically used when a patient cannot posture or when air travel is needed.
- The downside to this: A second surgery is required to remove the oil within a few months after the initial surgery—and is also associated with complications such as:
- Corneal toxicity
- High intraocular pressure (IOP), potentially leading to glaucoma
- Keratopathy
- Cataracts
Gotcha. So how does PYK-2010 work?
Via a step-by-step process:
To start: During surgery, the RD is repaired “in the usual manner [involving a laser and cannula] and retinal brakes are sealed with laser,” according to Pykus.
But after that: In lieu of injecting a gas or oil, the vitreous is replaced with optically clear saline solution, and PYK-2010 is applied to the peripheral retinal breaks location to form a solid gel.
- From there: The “gel barrier” blocks any fluid from entering the subretinal space and acts as a “sealant” on the retinal surface.
Fast forward several weeks: This gel biodegrades (naturally breaks down) and is eliminated from the eye.
And the advantages of this?
A few major bonuses—including a potential “paradigm shift in vitreoretinal surgery,” according to John Pollack, MD, FASRS, a vitreoretinal specialist at Illinois Retina Associates and Rush University Medical Center and former president of the American Society of Retina Specialists (ASRS).
Those other bonuses:
- No positioning is required for a patient following their RD surgery
- Improved and accelerated visual recovery
- A second surgery isn’t needed, thanks to the PYK-2101’s biodegradable properties
- Patients can air travel following surgery
- Patients experience no blurred vision post-surgery, as PYK-2101 was “designed to mimic the natural optics of the eye”
Sounds promising … now talk about this trial.
Here’s what we know so far: Conducted at vitreoretinal clinics across Australia, the PYK-2101-RD001 study is designed as a prospective, multicenter, open-label pilot trial.
Its purpose: To evaluate the safety and tolerability of PYK-2101 in 11 patients with RD undergoing pars plana vitrectomy.
- The timeframe: Evaluation of this will be within the first 16 weeks following surgery.
And what will be measured?
A few factors:
- Anatomical attachment rate
- Speed of visual acuity recovery
- Degree of cataract progression
- Change in IOP
- Adverse events
So when can we expect results?
Interim data is anticipated to be released in Q2 2025 (so within the next couple of months).
And what’s the plan beyond that?
The company is planning to submit an investigational device exemption (IDE)—which would allow PYK-2101 to be used in a clinical study to collect safety and effectiveness data—application to the FDA by the end of this year (Q4 2025) to enable a multicenter U.S. pivotal trial.
- This, of course, will also depend on financing and regulatory discussion.
Ahead of this: Pykus expects to meet with the federal agency to review PYK-2101’s continued clinical development and a trial design for its potential U.S. trial.