SAN DIEGO, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio^®" or the "Company"), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that its data will be presented at the Euretina Innovation Spotlight (EIS) being held on September 30, 2026, and Euretina being held on October 1-4, 2026, in Vienna, Austria.

EIS Presentation Details

Session: EURETINA Innovation Spotlight – Inherited and Rare Retinal Diseases

Title: Belite Bio Company Overview

Presenter: Hendrik Scholl, M.D., Chief Medical Officer, Belite Bio

Date and Time: September 30, 2026, 2:28 – 3:06 p.m. CEST

Location: Vienna Congress & Convention Center, Room 1/Hall A

Euretina Presentation Details

Session: EURETINA Free Paper 47 - Inherited Retinal Disease

Title: Topline Results from the Phase 3 DRAGON Study of Tinlarebant for Adolescent Stargardt Disease

Presenter: Michel Michaelides, M.D., Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, United Kingdom

Date and Time: October 4, 2026, 1:20 – 1:27 p.m. CEST

Location: Vienna Congress & Convention Center, Free Paper Forum 2

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 Stargardt disease type 1 (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 Switzerland, and Sakigake Designation in Japan for the treatment of STGD1.

About Stargardt Disease

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 needs, 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 and adult subjects with STGD1, which met its primary endpoint, and the Company’s new drug application for tinlarebant for the treatment of STGD1 was accepted by the U.S. Food and Drug Administration (FDA), with priority review, in August 2026. The FDA has set a Prescription Drug User Fee Act date of February 12, 2027. Tinlarebant is also currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent and adult subjects with STGD1 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:

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