The following transcript has been edited for clarity.

Good day, everyone. I'm Carlos Quezada Ruiz, MD, a retina specialist and chief medical officer at Alkeus Pharmaceuticals. We’re a biotech company based in Cambridge, Massachusetts, and we’re committed to helping people with retinal diseases preserve their vision.

I have the privilege of being here in beautiful Montreal. This morning at OIS Retina, I shared an update on the clinical development of gildeuretinol. I'm excited to report that gildeuretinol has entered late-stage clinical development, and patients are currently being enrolled in our global phase 3 trial, the NORTHSTAR trial. This will be the largest prospective interventional trial ever conducted in Stargardt disease.

We plan to enroll approximately 230 patients, who will be randomized 1:1 to receive either placebo or the active treatment, gildeuretinol, taken orally once daily for the duration of the trial, which is 2 years. The primary endpoint will be measured from month 6 to month 24, and it's based on the change and the rate of growth of retinal atrophic lesions.

The key secondary endpoint—something I’m particularly excited about as both a physician and company leader—is the change from baseline in low-luminance visual acuity. Why am I excited about this? Because this is a functional endpoint that we've seen positive results in our phase 2 trials in this target population, the TEASE-2 trial. We have also seen a significant benefit favoring gildeuretinol over placebo in our geographic atrophy program.

The fact that we're seeing those positive results across 2 different independent studies in 2 separate diseases that are related is highly encouraging for us as we enter phase 3 trials. So we're excited and confident about the outcomes and the possibility to accelerate the development of guildeuretinol and hopefully bring a potentially new and very much needed treatment for the Stargardt community around the world.

Thank you very much. RP