first-in-human clinicals: Theianova transforming keratoconus treatment
For millions of people worldwide, a diagnosis of keratoconus means a lifetime of deteriorating vision and invasive procedures. But what if the solution to halting this disease wasn't a surgery, but a simple eye drop?
"Keratoconus is a debilitating condition that impacts roughly one in 700 people, almost 11 million patients worldwide," explains Carissa Fonseca of Theianova.
The disease often strikes during a patient's most formative years, starting in their early teens and progressing into early adulthood. It is caused by the breakdown of collagen in the cornea. As the tissue weakens, the cornea can no longer withstand normal intraocular pressure and begins to bulge outward, severely disrupting the patient's vision and impacting their ability to drive, work, and engage socially.
Currently, if left untreated, the ultimate outcome is often a full corneal transplant. The available therapies to stop the disease's progression involve invasive, painful procedures, requiring significant recovery time.
Theianova is fundamentally changing this paradigm.
The Drop vs. The Procedure
Operating as an early clinical-stage biopharma startup, Theianova has engineered an elegant, non-invasive alternative to the current standard of care.
"Our solution is a simple eye drop consisting of a specific combination of a steroid and a growth factor. It is the only therapy that can actually regenerate corneal collagen."
By triggering the eye's cells to produce collagen and regenerate structural integrity, Theianova's therapy is designed to stop the disease in its tracks. It is vastly more accessible, offering patients the ability to halt disease progression without the associated pain, downtime, and clinical bottlenecks of surgical interventions.
A Breakthrough Years in the Making
The journey of Theianova perfectly illustrates the power of commercialising academic brilliance. The foundational science began years ago as a university research project.
A PhD student named Carol Greene, working in the lab of Colin Green alongside Professor Trevor Sherwin, was exploring stem cells and molecular mechanisms within the cornea. During their research, they discovered that a highly specific combination of a growth factor and a steroid had the profound effect of inducing corneal cells to produce new collagen. Recognising that keratoconus was the primary driver of corneal transplants globally, the team realised this breakthrough was the exact mechanism needed to treat the disease.
A Massive Clinical Milestone: First-in-Human
Having a scientific breakthrough in a university research lab is one thing, safely and effectively administering it to a human patient is an entirely different mountain to climb.
At the start of this year, Theianova achieved that monumental milestone, officially launching their first-in-human clinical trial.
"Taking a drug from the lab bench to the bedside is an immense challenge. Launching our first-in-human study this year and seeing this therapy actually reach patients with keratoconus has been a huge milestone and incredibly rewarding for the entire team."
With the drug's safety profile validated and actively in trials, Theianova now has the critical line of sight needed to refine their dosage, understand the real-world impact of the therapy, and push toward wider commercial availability.
Navigating the Uncertainty of Deep Tech
Bringing an academic discovery to market requires more than just good science, it requires the right commercial infrastructure.
"The partnership between Bridgewest Ventures and UniServices allowed us to transition this product from a research lab into a full-scale commercial operation," says Carissa.
In the deep tech and biopharma space, uncertainty is the only constant. Founders are operating on the cutting edge where no one else has the answers. Navigating that requires an investor who is comfortable with high-risk scientific development and deeply embedded in the commercialization process.
"Bridgewest Ventures has been an invaluable partner. The advice and support we received during our incubation, both from a business perspective and through their global network of scientific experts, have been the catalyst championing us through this process."
A De-Risked Commercial Opportunity
For the broader biotech and investment community, Theianova represents a highly compelling, de-risked commercial opportunity. They have successfully navigated the grueling pathway of testing stability, sterility, and safety, clearing the most significant developmental hurdles to get the drug into the clinic.
In addition to this de-risked profile is a massive, unmet clinical need. With diagnosis rates increasing year over year, the market demand from both clinicians and patients is overwhelming.
"Patients can't wait for it. They have few options to treat this condition, and clinicians have few tools with which to treat it. Having something that is non-invasive and easily accessible to patients all around the world... this is something that will become part of the clinician's armament of treatments."
With their first-in-human trials underway and a highly scalable solution in their hands, Theianova isn't just treating keratoconus, they are setting a new global standard for accessible ocular care.