FDA Accepts Belite Bio’s NDA for Tinlarebant in Stargardt Disease

The FDA has accepted Belite Bio’s new drug application (NDA) for tinlarebant for the treatment of Stargardt disease type 1 (STGD1) and granted the application Priority Review, the company announced. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027.

Smiley-Shaped Posterior Retinotomy for Large SMH

This surgical alternative is useful for thick and organized hemorrhages.

Manish Nagpal, MS, FRCS, FASRS; Anjana Mirajkar, MS, FVRS; and Malvika Singh, MS, DNB, FICO

Retina Today

KEY TAKEAWAYS Large or organized submacular hemorrhage (SMH) may respond suboptimally to standard pneumatic displacement. Smiley-shaped posterior retinotomy for SMH repair allows for controlled subretinal clot evacuation. Immediate clot removal facilitates rapid anatomical restoration, and OCT-based foveal recovery correlates strongly with visual improvement. The smiley-shaped technique described in these cases may be particularly useful in thick, extensive, or non-displacing SMH. A large, submacular hemorrhage (SMH) is a vision-threatening condition commonly associated with wet AMD, although it may also arise from polypoidal choroidal vasculopathy, myopic choroidal neovascularization, retinal arterial macroaneurysm, trauma, inflammatory choroidal neovascular membranes, or idiopathic causes (Figures 1-4). Experimental studies have demonstrated that rapid photoreceptor injury can occur from subretinal blood due to iron toxicity, mechanical disruption, and impaired metabolic exchange.1,2 Figure 1. Preoperative fundus photography showed confluent drusen at the posterior pole consistent with Doyne honeycomb dystrophy and a medium-sized subretinal hemorrhage due to active macular neovascularization (A). OCT imaging showed drusenoid pigment epithelial detachments with subretinal fluid and subretinal hyperreflective material, consistent with hemorrhage (B). Figure 2. Postoperative fundus photography demonstrated a smiley-shaped posterior retinotomy placed at the area of maximal clot thickness and away from the fovea, with associated subretinal fibrosis (A).

Leveraging the Uveoscleral Pathway After Failed Trabecular Meshwork–Based MIGS

A stepwise interventional approach.

Lorraine M. Provencher, MD

Glaucoma Today

KEY TAKEAWAYS Expanding options are allowing surgeons to tailor glaucoma treatment more precisely. In this case, combining sustained drug delivery with suprachoroidal outflow enhancement provided a physiologic method of lowering IOP after prior trabecular surgery. A 75-year-old pseudophakic woman with primary open-angle glaucoma (POAG) was referred for a surgical consultation. Two years ago, the patient underwent selective laser trabeculoplasty (SLT), followed by placement of a bimatoprost implant (Durysta, AbbVie) in each eye. SLT was repeated 5 months later in both eyes with little success. The patient subsequently underwent angle surgery with iStent Infinite (Glaukos) implantation plus viscodilation in both eyes. Despite this stepwise, layered approach targeting the trabecular outflow pathway, her IOP rose again after approximately 1 year of control. Upon evaluation, the patient’s visual acuity was 20/20 OD and 20/30 OS. Goldmann applanation tonometry revealed unmedicated IOPs of 28 mm Hg OD and 25 mm Hg OS. An optic nerve examination demonstrated cup-to-disc ratios of approximately 0.7, with superior and inferior retinal nerve fiber layer thinning in both eyes on OCT (Figure 1).

Featured Podcasts

Ophthalmology off the Grid

Open. Outspoken. It's Ophthalmology off the Grid—an honest look at controversial topics in the field.

View Feed

New Retina Radio

New Retina Radio is a place to hear stories about retina that are told nowhere else.

View Feed

Eyewire News: The Podcast

Get the latest information and breaking news in the ophthalmic field.

View Feed

Next-Generation FSYX Goggles Approved for Glaucoma

Eyetube

The FDA approves wireless pressure-modulating goggles for at-home glaucoma treatment; Bausch + Lomb launches a new PreserVision AREDS eye vitamin formation; and an Executive Strategic Advisor discusses the regulation environment for communication in eye care. Learn more about your ad choices. Visit megaphone.fm/adchoices

Eyewire News

08.11.2026

FDA Accepts Belite Bio’s NDA for Tinlarebant in Stargardt Disease

08.11.2026

First Patient Dosed in Artelo Biosciences' Phase 2 Study of Synthetic Cannabinoid for Glaucoma

08.11.2026

Omega Ophthalmics Closes $7 Million Financing, Schedules FDA Meeting for Gemini Refractive Capsule

08.11.2026

BostonSight Initiates Trial Examining Mental Health Outcomes with PROSE Treatment and Scleral Lenses

08.10.2026

PracticeAmerica Launches Physician-to-Physician Marketplace for Independent Practice Transitions

EyewireTV

08.05.2026

The Latest EyewireTV

Biocon Launches Eylea Interchangeable Biosimilar Yesafili in the US

EyePoint Completes Enrollment in Two Phase 3 Trials Evaluating Duravyu for DME

Topcon Receives CE Mark for GAIA Ultra-Widefield Retinal Imaging Device

Stocks

Cataract

Genetically Predisposed to Capsular Bag Instability

Seeing More of the Cornea

Elara 900: Reinventing the Clinical Workhorse

Addressing Inflammatory Dry Eye

Integrating MIGS Without Disrupting Efficiency

Visualizing the Angle

08.11.2026

Omega Ophthalmics Closes $7 Million Financing, Schedules FDA Meeting for Gemini Refractive Capsule

08.07.2026

UK Study Finds Ophthalmic Clinical Letters Increasingly Difficult for Patients to Read

08.07.2026

Harrow to Acquire Nasal Dry Eye Disease Treatment Tyrvaya from Viatris

08.07.2026

ForSight Robotics Reports 26 Fully Robotic-Assisted Cataract Surgeries in First-in-Human Study

Refractive

MIGS and Cataract Surgery

Seeing More of the Cornea

MIGS Device Selection in Practice

Canal-Based MIGS

Addressing Inflammatory Dry Eye

Exploring Nd:YAG Vitreolysis After Cataract Surgery for Symptomatic Eyes

08.10.2026

WaveFront Dynamics Expands Scleral Lens Options Through Bausch + Lomb, WAVE Eye Care Integrations

08.07.2026

UK Study Finds Ophthalmic Clinical Letters Increasingly Difficult for Patients to Read

08.05.2026

Staar Surgical Appoints Warren Foust as President and CEO

08.03.2026

MDConsult AI Launches Pre-Consultation Platform for Cataract and Refractive Practices

Stay Updated

Follow Eyewire News

Retina

Smiley-Shaped Posterior Retinotomy for Large SMH

Unity VCS - 27 Gauge Vitrectomy

Unity VCS - Core Technologies, Intelligent Fluidics

Unity VCS - Intelligent IOP

Secondary IOL Surgery Is Unprofitable Under Current Medicare Reimbursement Rates. Now What?

Unity VCS – 4D Phaco & Intelligent Fluidics

08.11.2026

FDA Accepts Belite Bio’s NDA for Tinlarebant in Stargardt Disease

08.10.2026

Oculis to Acquire Global Rights to Privosegtor from Accure Therapeutics

08.07.2026

UK Study Finds Ophthalmic Clinical Letters Increasingly Difficult for Patients to Read

08.06.2026

Norlase Expands European Footprint with Direct Sales Model in Germany

Glaucoma

Leveraging the Uveoscleral Pathway After Failed Trabecular Meshwork–Based MIGS

GATT in a Young Patient With Uveitic Glaucoma

The Buzz on Eyetube

Hemorrhagic Choroidals After Combined Phaco-Trabeculectomy

Inside Residency Training at the Moran Eye Center

Three Weeks of the Wrong Diagnosis—and a Minimally Invasive Path Forward

08.11.2026

First Patient Dosed in Artelo Biosciences' Phase 2 Study of Synthetic Cannabinoid for Glaucoma

08.10.2026

Nicox Licensee Submits Application for Glaucoma Candidate NCX 470 in China

08.07.2026

UK Study Finds Ophthalmic Clinical Letters Increasingly Difficult for Patients to Read

08.06.2026

Norlase Expands European Footprint with Direct Sales Model in Germany