Eyeconis has kicked off a first-in-human (FIH) clinical trial evaluating its investigational candidate for treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD).
First up: Eyeconis.
Operating out of Redwood, California, the newly-dubbed clinical-stage biotechnology company was launched in 2024 as a spin-off from Ascendis Pharma and Frazier Life Sciences.
Its purpose: to develop, manufacture, and commercialize Ascendis’ “transient conjugation” (TransCon) flexible technology platform of ophthalmic assets as part of a global exclusive rights agreement
- Per this agreement, Ascendis will retain equity plus up to $248 million in milestones and single-digit royalties for any global net sales of commercial products Eyeconis launches.
As for the disease pipeline: wet AMD, diabetic macular edema (DME), retinal vein occlusion (RVO), and geographic atrophy (GA)
Next: Talk more about TransCon.
First: The term TransCon comes from the ability to temporarily (transiently) link an inert carrier to a parent drug with known biology.
And in this context: TransCon was adapted for ophthalmology by utilizing biodegradable hyaluronic acid (HA)-based hydrogel microspheres optimized for ocular delivery.
And this technology platform?
The TransCon technology platform is designed to develop drugs by combining the aforementioned known biology with “the benefits of prodrug and sustained-release technologies.”
The potential: to reduce treatment burden while optimizing and improving therapeutic effects such as:
- Enhanced efficacy
- Improved tolerability and convenience
- Higher development success rate
- Reduce caregiver burden
So what should we know about these drugs?
They consist of three components: the parent drug, carrier, and linker. They’re also applicable to antibodies, antibody fragments, proteins, peptides, small molecules in multiple therapeutic areas.
Administration: is via either a systematic or local delivery—dependent on the carrier used—to meet a specific therapeutic goal.
Expand on that.
Its inert carrier shields the drug, while the linker temporarily binds the drug and carrier.
After intravitreal (IVT) injection administration, the drug undergoes a sustained release while the carrier and linker naturally dissipate over time.
Take note: This requires no implant, surgical procedure, or delivery device.
Can we get a visual of how this works?
Click here for a virtual breakdown (from Ascendis).
So how many assets does Eyconis have so far?
Just the one: EYC-0305 (TransCon aVEGF).
This lead asset is an anti-vascular endothelial growth factor (VEGF) antibody fragment (fAb) engineered to offer long-acting drug exposure in the retina via single IVT injection.
- The target duration: 6+ months
And I take it that’s what this FIH is targeting?
Indeed. Dubbed OVERTURE, the phase 1b/2a clinical trial (NCT07587515) is investigating the safety and tolerability of EYC-0305 among wet AMD patients.
More details:
- Design: open-label, multiple ascending dose
- Participants: an estimated 30 adults (aged 50+) with wet AMD
- Inclusion / exclusion criteria here
- Setup: patients to receive a single dose (with four potential dose levels) of EYC-0305, administered via IVT injection every 24 weeks.
- This will be without traditional monthly loading doses
And what will researchers evaluate, specifically?
Two primary outcomes (both measured at Week 72): ocular and systemic treatment-emergent adverse events (TEAs).
Per Eyconis: The study will also evaluate pharmacokinetics and measures of disease activity to determine EYC-0305’s next clinical development stage—“including the potential for durability beyond 6 months.”
Now to the potential.
For that: OVERTURE trial investigator Charles C. Wykoff, MD, PhD, weighed in.
As Director of Research at Retina Consultants of Texas and scientific advisor to Eyconis, Dr. Wykoff emphasized that, despite advancements in the exudative retinal disease treatment space, “there remains a significant unmet need for therapies that can safely and consistently extend dosing intervals while maintaining optimal disease control.”
- He added: “If EYC-0305 can deliver durable, predictable anti-VEGF activity from the first injection through 6 months or longer, it could potentially improve disease control and visual outcomes while fundamentally reducing treatment burden for patients, caregivers, and our global health-care system.”
And lastly: When might we see some data from this?
Excellent question … ClinicalTrials.gov is reporting a study completion date of May 2028; so we can likely anticipate topline results before then.
As always, stay tuned!