The following transcript has been edited for clarity.

My name is Philip J. Ferrone, MD, FASRS, from Vitreoretinal Consultants of New York, and I'm here at Retina World Congress 2026 presenting data on the TEASE program.

The TEASE program is a series of studies looking at Stargardt disease. Stargardt disease has an incidence of approximately 1 in 8,000 in the United States and affects approximately 43,000 people in the US. Ninety-five percent of the patients with Stargardt disease have an abnormality of the ABCA4 gene. This is autosomally recessively inherited. In Stargardt disease, there’s impaired vitamin A transport which causes toxic vitamin A dimerization and lipofuscin buildup, which leads to retinal pigment epithelium (RPE) and photoreceptor cell death.

Gildeuretinol (ALK-001; Alkeus Pharmaceuticals) is a once-daily oral capsule engineered to reduce toxic vitamin A dimerization. It reduces dimerization by up to 80% and is metabolized like vitamin A and does not modify the visual cycle.

The TEASE program is made up of TEASE-1, TEASE-2, TEASE-3, and TEASE-4, as well as a new phase 3 study called the NORTHSTAR study. TEASE-1 looked at advanced disease and showed approximately 30% reduction in growth of atrophic lesions over 2 years. TEASE-2 looked at moderate disease and showed a similar decrease in progression of ellipsoid zone (EZ) loss, though the P value was not significant in TEASE-2 as compared to TEASE-1, where it was statistically significant. TEASE-3 looks at early disease. Interim analysis of 5 patients has shown a drug effect in those patients compared to their genotypically identical siblings looked at over the same time period without treatment. TEASE-4 is a safety study. Thus far, on a large number of patients, [gildeuretinol] has not shown any safety signal.

Gildeuretinol in all the studies was well tolerated and the TEAEs were mild to moderate. There were no reports of chromatopsia, delays in dark adaptation, or night blindness, indicating that gildeuretinol does not negatively affect the visual cycle. Overall, there were no clinically meaningful differences in lab panels between gildeuretinol-treated patients and placebo.

In the phase 3 global NORTHSTAR study, we’re investigating the safety and efficacy of gildeuretinol in advanced Stargardt disease. There are approximately 115 patients in each arm. One arm receives gildeuretinol 14 mg and the other arm is placebo. It's a 2-year study. The patient population is 8 years old to 45 years old. Patients are required to have a well-demarcated area of definitely decreased autofluorescence (DDAF) as measured by fundus autofluorescence (FAF). The efficacy endpoints, the primary endpoint is an annual rate of growth of retinal atrophic lesions by FAF from month 6 to 24. And the key secondary endpoint is a change in low-luminance visual acuity (LLVA) from baseline to month 24 as measured by ETDRS.

We're looking forward to the results of this study. Recruitment, as I mentioned, is underway. Thank you. RP