Chimelrule

[Belite Bio @belite_bio]

Belite Bio has completed its NDA submission to the U.S. FDA for tinlarebant, an investigational, once-daily oral therapy for treatment of Stargardt disease type 1. Thank you to all who made this possible.

Read more: https://t.co/7e8URDu2rD

#BeliteBio #Stargardtdisease

[Belite Bio @belite_bio]

We’re pleased to share that Belite Bio received Orphan Drug Status for tinlarebant in Stargardt disease (STGD1) in Switzerland.

#StargardtDisease #BeliteBio

Learn more: https://t.co/ykxTD303hw

[Chimelrule @chimelrule]

@belite_bio Congrats!!🎉

[Belite Bio @belite_bio]

We initiated a rolling NDA submission to the U.S. FDA for our investigational oral therapy for Stargardt disease type 1.

Learn more: https://t.co/cHzwL0m9q5

[Ophthalmology Times @OphthTimes]

Belite Bio initiated a rolling New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) for tinlarebant, an investigational oral therapy targeting Stargardt disease type 1 (STGD1)

https://t.co/9pWHUGHbDp

[Chimelrule @chimelrule]

Big milestone for Belite Bio 🚀

They’ve announced the start of a rolling NDA submission for Tinlarebant - a key step toward potential approval.

Details here: https://t.co/zi0lkb0Xw7

[Chimelrule @chimelrule]

@KubotaPharma so what are the steps to get it in Europe? any contacts ?

[Ophthalmology Times @OphthTimes]

Results of a multicenter controlled clinical trial of the photovoltaic retina implant microarray (PRIMA, Science Corporation) system showed that the device resulted in “a significant improvement in visual acuity (VA) from baseline to month 12.

https://t.co/xEKgcHrVG7

[Science Corporation @ScienceCorp_]

“We found that patients [in clinical trials] were able to regain the ability to read – not fast, not quickly, but they really could start to read again using a retinal prosthesis.”

Frank Brodie, MD, Science’s Medical Director for Vision and PRIMA, joined @_BrightFocus to discuss the PRIMA brain-computer interface (BCI) retinal implant, the first treatment shown in clinical trials to restore functional vision for geographic atrophy due to AMD.

Listen to the entire discussion here: https://t.co/u1d5bIkQeY

[Chimelrule @chimelrule]

@ScienceCorp_ @OphthTimes @NEJM congrats, question is when it will be available to patients

[Chimelrule @chimelrule]

@RetinaToday Would be amazing to get the same pipeline poster for stargardt disease

[Chimelrule @chimelrule]

Anyone attending #AlkeusPharma presentation at #JPM2026 ?
There’s no webcast unfortunately

[Chimelrule @chimelrule]

@drsmusunuri Awesome, what are the next steps?

[Chimelrule @chimelrule]

@FasserChristina An interesting question is how long it will take to move from approval in adolescents to approval in adults, and what steps are required along the way- for example, conducting a pivotal study, relying on off-label prescribing, and other regulatory measures.

[Belite Bio @belite_bio]

🔴Today, Belite Bio reported positive topline Phase 3 DRAGON results for Tinlarebant — the first therapeutic candidate to demonstrate efficacy in a global Phase 3 trial in Stargardt disease. Learn more: https://t.co/fW5NK584aF

[bionic-vision.org @bionicvisionorg]

🚨 Breakthrough alert: A new study in the @NEJM reports that the PRIMA subretinal implant helped restore meaningful central vision in ~80% of participants with advanced geographic atrophy (an untreatable form of #AMD).

https://t.co/xNdCtMcPih

#BionicVision #NeuroTech

[Chimelrule @chimelrule]

@OphthTimes Did #AlkeusPharma say anything about their plan to submit NDA? On their website they used to say “by the end of 2024” and then “as soon as possible in 2025”

[Chimelrule @chimelrule]

Anyone attended #AlkeusPharma presentation this morning? #AAO2025

[Alkeus Pharma @alkeuspharma]

We are pleased to share that results from the clinical study of our investigational therapy in moderate Stargardt disease (TEASE-2) will be presented during Retina Subspecialty Day at AAO on Saturday, October 18.
https://t.co/eN1mTzF437
#AlkeusPharma #AAO2025 #Retina

[Life Science Report @lifesciencerpt]

Belite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant $BLTE https://t.co/pI9iMIZkZo