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👁️ HEALTH ON THE FRONT LINE

Special Coverage · February 26, 2026 · Vall d'Hebron Research Institute · Barcelona

 

📅  OPHTHALMOLOGY · DIABETES · BIOTECHNOLOGY

Eye drops can change the fate of 537 million diabetics: D-Sight starts the world's first clinical trial to treat retinopathy in its earliest stages

For 15 years, doctors Rafael Simó and Cristina Hernández quietly investigated a mechanism that no one took seriously: neurodegeneration of the retina occurs before any visible vascular damage appears. Today, its spin-off D-Sight is weeks away from confirming in humans that a simple eye drop with sitagliptin can slow down that process. If they succeed, they will have opened a therapeutic window that did not exist anywhere in the world.

 

🌍 537M people with diabetes in the world

👁️ ~30% of diabetics develop retinopathy

🚫 0 Treatments for early stages

 

Source: IDF Diabetes Atlas 2025 / VHIR / D-Sight

 

 

🔍  THE INVISIBLE DISEASE THAT STEALS VISION

 

Diabetic retinopathy is one of the great silent tragedies of modern medicine. It settles in painlessly, without symptoms in its early stages, and moves methodically until it causes irreversible damage. It is the most common microvascular complication of diabetes and the leading preventable cause of visual impairment and blindness in people of working age worldwide. In concrete numbers: it affects approximately 30% of patients with type 2 diabetes and practically all type 1 diabetics with more than 20 years of evolution.

The mechanism that guided all research for decades was vascular: diabetes damages the blood vessels of the retina, causes microaneurysms, hemorrhages, exudates and finally macular edema or pathological vascular proliferation. From this paradigm, the available treatments are photocoagulator laser and intravitreal injections of anti-VEGF drugs, both highly invasive, expensive interventions, with frequent adverse effects and only applied when the disease has already caused serious structural damage.

"There are currently no therapeutic options for the earliest stages of diabetic retinopathy. We are facing an unmet medical need on a global scale." — Carla Maté Goldar, CEO and co-founder of D-Sight

 

What no one had been able to do until now was to intervene in the initial stages, when the diagnosis is recent and the damage is still reversible. The cause: the scientific community did not have a clear therapeutic target in that window. There was no way to act because there was no recognized mechanism to act. Until the VHIR team demonstrated something that changed the field: neurodegeneration of the retina precedes microvascular involvement.

 

💡  THE FINDING THAT CHANGED THE PARADIGM: NEURO BEFORE VASCULAR

 

The scientific history of D-Sight begins more than 15 years ago in the Diabetes and Metabolism Research Group of the Vall d'Hebron Research Institute (VHIR), led by Dr. Rafael Simó, head of the Endocrinology and Nutrition Service at Vall d'Hebron University Hospital. Together with Dr. Cristina Hernández, Simó developed a line of research that challenged the dominant vascular paradigm: the retina is not only a vascular tissue, but a specialized neural tissue.

The hypothesis, then controversial, was gaining evidence: in the preclinical stages of diabetic retinopathy, before the first detectable ophthalmological signs appear, there is already loss of retinal ganglion cells, reduction in the thickness of the nerve fiber and alterations in the function of the optic nerve. Neurodegeneration precedes and partly drives vascular damage. If you can stop this neural process from the beginning, you can prevent the cascade of damage that culminates in blindness.

"It has taken us 15 years to convince the scientific community that retinal neurodegeneration precedes microvascular involvement. Now there is no longer any doubt." — Dr. Rafael Simó, Scientific Co-Founder of D-Sight and Head of the Diabetes and Metabolism Group, VHIR

 

The next challenge was to find the drug capable of exerting this neuroprotection in a safe, effective and accessible way. After years of screening, the answer was surprising to many: sitagliptin, a DPP-4 enzyme inhibitor already widely used as an oral antidiabetic, proved to be the most potent, cost-efficient candidate with the highest margin of safety for topical ocular application. The finding opened an unexpected avenue: pharmacological repurposing, that is, a drug already approved in another indication, now reformulated as eye drops for a completely new use.

 

🏢  D-SIGHT: FROM PUBLIC RESEARCH TO THE GLOBAL MARKETPLACE

 

D-Sight was set up as a spin-off of VHIR under an innovative 'entrepreneur in residence' model, the first in the history of the Catalan institute. Carla Maté Goldar, an expert in knowledge transfer and scientific entrepreneurship, took on the role of CEO and co-founder, providing the entrepreneurial dimension that researchers needed to make the leap from the laboratory to the market.

The company is currently developing two main lines: sitagliptin eye drops for diabetic retinopathy in early stages – its priority asset – and a second neuroprotective candidate for glaucoma, a pathology that shares the mechanism of optic nerve damage but already has existing treatments, although limited to reducing intraocular pressure without offering real neuroprotection.

 

💰 FUNDING STRUCTURE 💼 Clave Capital (Clave Innohealth): Continuous private investment since incorporation. He leads the last round. [Lead Investor] 🏛️ CPP 2024 Programme — Spain: 1.5 million euros — Public-Private Partnership Call. [Public funding] 🔬 Prous Institute for Biomedical Research: New strategic partner in AI and life sciences. [Strategic Investor] 📊 Total raised: €5 million accumulated (last round: €2 million in 2026). [Milestone 2026]

 

The planned business model is to license a large multinational pharmaceutical company for global commercialization, once D-Sight has completed the clinical validation phases. The company expects to reach the market in the period 2032-2033, a horizon that Maté describes as 'moderately optimistic' but adjusted to the usual times of international pharmaceutical regulation.

 

🧬  THE PHASE I CLINICAL TRIAL: WHAT WILL BE TESTED

 

The study that will begin in the coming weeks is a Phase I clinical trial, the first step of clinical development in humans. Their goal is not to prove that eye drops cure diabetic retinopathy, but something more basic and fundamental: to confirm that it is safe. The trial will administer the ophthalmic formulation of sitagliptin to healthy volunteers and assess its tolerability, absorption, and absence of local and systemic adverse effects.

The Spanish Agency for Medicines and Health Products (AEMPS) has already advanced in the regulatory process, and D-Sight completed the industrial scale-up studies necessary to produce the drug with the GMP (Good Manufacturing Practice) standards required for human trials. The horizon to complete this phase is 2026 itself, with expected results in the second half of the year.

 

#	STAGE	OBJECTIVE AND CONTENT	STATE
🔬	Phase I (2026)	Healthy volunteers — Safety and tolerability of sitagliptin in eye drops. No expected toxicity according to animal models.	🟢 ONGOING
🧪	Phase II (2026–2027)	Patients with early diabetic retinopathy — Clinical efficacy, optimal dose, and biomarkers of response.	🟡 PLANNED
📊	Phase III (2028–2030)	Multicenter pivotal trial — Confirmation of efficacy and safety profile on a large scale for regulatory registration.	⚪ FUTURE
💊	Market (2032–2033)	Global commercialization with a multinational pharmaceutical partner through an operating license.	⚪ FUTURE

Source: D-Sight / VHIR / Medical Writing, February 2026

 

The choice of healthy volunteers for Phase I is standard in pharmaceutical development: it is about evaluating safety without exposing patients with active pathology to a non-validated drug. Researchers are especially confident in the tolerability of the compound given that sitagliptin has an extensive history of oral use without major adverse effects, and the formulation as eye drops—locally administered and topographically confined—minimizes systemic absorption.

The most relevant aspect for patients is that the Phase I trial is not the final destination: it is the starting point for Phase II efficacy in patients with early diabetic retinopathy, scheduled for the same year 2026. At that stage, it will be confirmed whether eye drops effectively slow down retinal neurodegeneration in real patients.

"This study is the first step in validating the therapeutic potential of the drug and moving towards future phases of research in patients with diabetic retinopathy." — Dr. Rafael Simó, VHIR

 

 

📊  ADVANTAGES OVER CURRENT TREATMENTS

 

To understand the magnitude of the breakthrough represented by sitagliptin eye drops, it is necessary to compare it with the therapeutic arsenal currently available. Existing treatments share a characteristic that limits them structurally: they can only act when the disease has already progressed to intermediate or advanced stages.

 

TREATMENT	STADIUM	INVASIVENESS	EF. ADVERSE	ADMIN ROUTE.
Current treatment (laser)	Advanced stages only	High	Yes	Surgery/Hospital
Anti-VEGF (injection)	Advanced stages only	High	Frequently Asked	Intravitreal injection
Sitagliptin eye drops (D-Sight)	Early phases ✅	Very low	Unexpected	Self-administered ✅

Source: VHIR / D-Sight / own elaboration

 

🎯 The decisive factor: D-Sight eye drops are the only candidate in development capable of acting at the time of diabetes diagnosis, before any clinical signs of eye involvement appear. It does not require hospital infrastructure, can be self-administered at home and its production cost is significantly lower than that of anti-VEGF biologics.

 

🔵  THE SECOND FRONT: GLAUCOMA

 

The Phase I clinical trial is 'useful for both indications', according to Dr. Simó. In addition to diabetic retinopathy, the same molecule is being developed as a neuroprotective therapy for glaucoma. This distinction is important: in glaucoma there are already eye drops on the market, but they all act by reducing intraocular pressure, without offering direct protection to the neurons of the optic nerve. D-Sight targets that therapeutic gap with its neuroprotective formulation.

The advantage is that the glaucoma research base can advance at a faster pace, by sharing the mechanism of action with the already more mature retinopathy program. The dual Phase I will allow relevant safety data to be obtained for both indications simultaneously, shortening the development times of the second candidate.

 

🌐  THE CONTEXT: A SILENT DIABETES PANDEMIC

 

The epidemiological context makes D-Sight's success not just a scientific milestone: it is a public health emergency. The International Diabetes Federation (IDF) estimates that in 2025 there are 537 million people with diabetes in the world, a figure that could reach 643 million in 2030 and 783 million in 2045. Most live in low- and middle-income countries, where access to current expensive and invasive retinopathy treatments is virtually non-existent.

A low-cost, self-administerable eye drop that can be applied from the initial diagnosis of diabetes would radically transform the preventive approach to diabetic blindness on a global scale. Spain, through VHIR and D-Sight, is positioned on the frontier of this transformation. The Vall d'Hebron Hospital, recognized as the 20th best hospital in the world and the first in Spain in its specialty according to Newsweek, endorses the institutional solidity behind the project.

 

 

👁️

15 years of research that no one believed, now weeks away from being tested on humans.

If eye drops work, millions of people around the world will have the chance to preserve their vision for the first time before losing it.

 

 

Sources: Vall d'Hebron Research Institute (VHIR) · D-Sight · ConSalud.es · Medical Writing · Action Vision Spain · InfoDiabetic · Biotech Spain · InnovaSpain · The Referent · IDF Diabetes Atlas 2025

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