Press Releases April 27, 2026 08:00 AM

Belite Bio Announces Oral Presentation at the Retinal Therapeutics Innovation Summit

Belite Bio to Present Positive Phase 3 Results for Tinlarebant in Stargardt Disease at Retinal Therapeutics Innovation Summit

By Hana Yamamoto BLTE
Belite Bio Announces Oral Presentation at the Retinal Therapeutics Innovation Summit
BLTE

Belite Bio announced an upcoming oral presentation of positive topline results from its Phase 3 DRAGON trial evaluating tinlarebant for Stargardt disease type 1 (STGD1). Tinlarebant showed a significant 35.7% reduction in the growth of atrophic retinal lesions compared to placebo, with a strong safety profile. The therapy targets accumulation of bisretinoid toxins causing retinal degeneration and has various regulatory designations, with an ongoing FDA rolling submission.

Key Points

  • Phase 3 DRAGON trial showed tinlarebant reduces retinal lesion growth by 35.7% in STGD1 patients.
  • Tinlarebant targets serum retinol binding protein 4 to reduce harmful bisretinoid accumulation causing retinal degeneration.
  • Multiple regulatory designations and ongoing FDA rolling submission indicate strong development momentum in treating retinal diseases.
  • Sectors impacted: Biotechnology, Pharmaceuticals, Healthcare, Ophthalmology.

SAN DIEGO, April 27, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), (“Belite Bio” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will give an oral presentation at the Retinal Therapeutics Innovation Summit being held on May 1, 2026, in Denver, Colorado.

The presentation will cover the previously disclosed positive topline results from the Phase 3 DRAGON trial, which evaluated tinlarebant for the treatment of Stargardt disease type 1 (STGD1). In the study, tinlarebant demonstrated a clinically meaningful 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo along with a strong safety profile. The presentation will be followed by a brief question and answer session.

Presentation Details
Session: Small Molecules to the Rescue
Title: Topline Results from a 2-year Phase 3 Study of Oral Tinlarebant in Adolescent Patients with Stargardt Disease
Presenter: Nathan L. Mata, Ph.D., Chief Scientific Officer, Belite Bio
Date and Time: May 1, 2026, 10:55-11:10 a.m. MDT
Location: Sheraton Denver Downtown Hotel, 1550 Court Place, Denver, CO

About Tinlarebant (a/k/a LBS-008)
Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, Japan, and Sakigake Designation in Japan for the treatment of STGD1. In April 2026, Belite Bio initiated a rolling submission to the FDA for tinlarebant in the treatment of STGD1.

About Stargardt Disease (STGD1)
STGD1 is the most common inherited macular dystrophy in both adults and children. The disease is caused by mutations in a retina-specific gene (ABCA4), which results in progressive accumulation of bisretinoids leading to retinal cell death and progressive loss of central vision. The fluorescent properties of bisretinoids and the development of high-resolution retinal imaging systems have helped ophthalmologists identify and monitor disease progression. Currently, there are no approved treatments for STGD1.

About Belite Bio
Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite Bio’s lead candidate, Tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook, or visit us at www.belitebio.com.

Media and Investor Relations Contact:
Jennifer Wu
[email protected]

Julie Fallon
[email protected]


Risks

  • FDA approval is not guaranteed despite positive trial results and regulatory designations.
  • Market adoption and reimbursement for a novel retinal therapy remain uncertain.
  • Future trial outcomes (e.g., ongoing DRAGON II and PHOENIX trials) could impact clinical and commercial prospects if results differ from Phase 3 findings.

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