Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1 - Report - MDSpire
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Safety and Impact of Gildeuretinol Acetate on Retinal Atrophy in Stargardt Disease: Results From TEASE-1

  • By

  • Christine N. Kay

  • Leonide Saad

  • Gabrielle DeBartolomeo

  • Neil Bressler

  • Stephen H. Tsang

  • Kimberly Stepien

  • Paul Bernstein

  • Byron L. Lam

  • Ilyas Washington

  • Michael B. Gorin

  • TEASE-1 Study Group

  • Arsany Makkar

  • Hendrik Scholl

  • Mahmood Seyd Shah

  • Mandeep Singh

  • Shazia Khan

  • Mary Frey

  • Robert L. Roseman

  • Kaushik M. Hazariwala

  • Jing Zhang

  • Sarah Justus

  • Sophia Karen Park

  • Christine Xu

  • Thomas Connor

  • Dennis Han

  • Judy Kim

  • David Weinberg

  • William Wirostko

  • Kurt Pfeifer

  • Heather Toth

  • Krissa Packard

  • Eleanor Dorsey Veh

  • Vesper Williams

  • Kaitlin McKenney

  • Brittany Rego

  • Patricia Winter

  • Hannah Sheppard

  • Stephanie Moebius

  • Angela Urmanski

  • Amanda Daubert

  • Senad Novic

  • Potyra R. Rosa

  • Kimberley Wegner

  • Elizabeth Nuttall

  • Kelliann Farnsworth Ordonez

  • William C. Hubbard

  • Melissa Chandler

  • Becky Weeks

  • Donnell Creel

  • Steven Nusinowitz

  • Emma Stackpole

  • Anna Matynia,

  • Julliane Bacerdo

  • October 1, 2026

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Clinical Report: Gildeuretinol Acetate and Retinal Atrophy in Stargardt Disease

Overview

In the 24-month TEASE-1 trial, oral gildeuretinol acetate was associated with slower growth of retinal atrophic lesions than the untreated comparison group. The reported mean difference in growth rate was −0.050 mm/year (95% CI, −0.072 to −0.027; P < .001), corresponding to a 21.6% relative reduction; most adverse events were mild or moderate and similarly distributed between groups.

Background

Stargardt disease is an autosomal recessive macular dystrophy associated with progressive loss of photoreceptors, retinal pigment epithelium, and underlying choriocapillaris. It can cause progressive visual impairment and other visual disturbances, with symptoms commonly beginning in adolescence. ABCA4-associated abnormalities are believed to promote formation of toxic vitamin A dimers, or bisretinoids, in the retina. The supplied article context states that no approved therapies were available for Stargardt disease.

Data Highlights

MeasureTEASE-1 result
Study design and durationMulticenter, double-masked, placebo-controlled randomized clinical trial; 24 months
Study population50 randomized participants and 54 natural-history cases; conducted at 7 US sites
Primary endpointGrowth rate of well-delineated retinal atrophic lesions measured by fundus autofluorescence
Difference in lesion growth rate−0.050 mm/year (95% CI, −0.072 to −0.027; P < .001)
Relative reduction in growth21.6% versus the untreated group; 14.9% in a prespecified sensitivity analysis limited to randomized participants (P = .008)
SafetyMost adverse events were mild or moderate and similarly distributed between treatment and control groups

Key Findings

  • TEASE-1 assessed daily oral gildeuretinol acetate for safety and effects on retinal atrophic lesion growth over 24 months.
  • The analysis included 50 randomized participants and 54 natural-history cases; the trial was conducted at 7 US sites.
  • Gildeuretinol was associated with a mean lesion-growth-rate difference of −0.050 mm/year versus the untreated group (95% CI, −0.072 to −0.027; P < .001), a 21.6% relative reduction.
  • In a prespecified sensitivity analysis restricted to randomized participants, the relative reduction was 14.9% (P = .008).
  • Most adverse events were mild or moderate and were similarly distributed between treatment and control groups.
  • The supplied related-article context reports that the TEASE program has shown reductions in atrophic lesion growth and that the phase 3 NORTHSTAR trial is enrolling; separate TEASE-3 interim reporting described stabilization of vision and retinal structure in early-stage disease.

Clinical Implications

The TEASE-1 results provide trial evidence that gildeuretinol acetate was associated with slower expansion of retinal atrophic lesions over up to two years, with most reported adverse events mild or moderate and similarly distributed between groups. The supplied context describes clinical management of Stargardt disease as primarily supportive and states that no disease-modifying therapy had been approved as of June 4, 2026.

Conclusion

In TEASE-1, gildeuretinol acetate was associated with reduced growth of retinal atrophic lesions compared with the untreated group over 24 months. The supplied trial summary notes that additional work is needed.

Related Resources & Content

  1. JAMA Ophthalmology, 2026 — Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1 Randomized Clinical Trial
  2. Retinal Physician, 2026 — TEASE Program Builds Case for Gildeuretinol in Stargardt
  3. Retinal Physician, 2025 — Oral Gildeuretinol Slows Stargardt Progression
  4. Ophthalmology and Therapy, 2026 — Update on the Management of ABCA4 Retinopathy (Stargardt Disease)
  5. Retinal Physician — New Gildeuretinol Findings From Retina Society Recommendations
  6. retinal physician — Oral Gildeuretinol Slows Stargardt Progression
  7. Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1 Randomized Clinical Trial
  8. Update on the Management of ABCA4 Retinopathy (Stargardt Disease)
  9. TEASE Program Builds Case for Gildeuretinol in Stargardt
  10. Oral Gildeuretinol Slows Stargardt Progression
  11. New Gildeuretinol Findings From Retina Society Recommendations
  12. AAO 2026: Tinlarebant in Stargardt disease: Jacque Duncan, MD, on DRAGON results | Eye Care Network - Ophthalmology Times

Original Source(s)

Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1

  • by Christine N. Kay, Leonide Saad, Gabrielle DeBartolomeo, Neil Bressler, Stephen H. Tsang, Kimberly Stepien, Paul Bernstein, Byron L. Lam, Ilyas Washington, Michael B. Gorin, TEASE-1 Study Group, Arsany Makkar, Hendrik Scholl, Mahmood Seyd Shah, Mandeep Singh, Shazia Khan, Mary Frey, Robert L. Roseman, Kaushik M. Hazariwala, Jing Zhang, Sarah Justus, Sophia Karen Park, Christine Xu, Thomas Connor, Dennis Han, Judy Kim, David Weinberg, William Wirostko, Kurt Pfeifer, Heather Toth, Krissa Packard, Eleanor Dorsey Veh, Vesper Williams, Kaitlin McKenney, Brittany Rego, Patricia Winter, Hannah Sheppard, Stephanie Moebius, Angela Urmanski, Amanda Daubert, Senad Novic, Potyra R. Rosa, Kimberley Wegner, Elizabeth Nuttall, Kelliann Farnsworth Ordonez, William C. Hubbard, Melissa Chandler, Becky Weeks, Donnell Creel, Steven Nusinowitz, Emma Stackpole, Anna Matynia,, Julliane Bacerdo

  • October 1, 2026

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