• Category: Pipeline
ViaLase's IDE trial treats first patient with novel femtosecond laser procedure
Pipeline

ViaLase's IDE trial treats first patient with novel femtosecond laser procedure

Pivotal study is comparing ViaLuxe Laser System with FLigHT as an incision-free canal procedure against SLT for POAG treatment.
FDA clears Zhongmou Therapeutics' IND for RP optogenetic gene therapy
Pipeline

FDA clears Zhongmou Therapeutics' IND for RP optogenetic gene therapy

Clearance of ZM-02 marks the first optogenetic gene therapy originating from China to receive U.S. IND authorization.
Belite Bio reports phase 3 topline data on oral tinlarebant for Stargardt disease
Pipeline

Belite Bio reports phase 3 topline data on oral tinlarebant for Stargardt disease

DRAGON study is evaluating the once-daily tablet for reducing lesion growth among adolescent patients over a 24-month period.
Precise Bio performs first transplant with 3D-printed cornea implant
Pipeline

Precise Bio performs first transplant with 3D-printed cornea implant

Procedure deemed successful in treating first fully blind patient using corneal bio-implant made from corneal endothelial cells.
First autofocus glasses offer lightweight vision correction
Pipeline

First autofocus glasses offer lightweight vision correction

New prototype design for prescription-based smart eyewear could be an alternative to traditional progressive lenses.
Ocuvex resubmits FDA CRL for brimonidine tartrate 0.35% NDA
Pipeline

Ocuvex resubmits FDA CRL for brimonidine tartrate 0.35% NDA

Shared by partner SPARC, update follows 2+ years after the 2022 submission of investigational OAG and OHT eye drop was rejected in July 2023.
Coave Therapeutics debuts lead SCS gene therapy for retinal vascular diseases
Pipeline

Coave Therapeutics debuts lead SCS gene therapy for retinal vascular diseases

In-office, suprachoroidal delivery of CoTx-101 offers potential for durable and long-lasting vision gains in treating wet AMD and DME.
PolyActiva and RareSight to advance long-acting therapies for pediatric IRDs
Pipeline

PolyActiva and RareSight to advance long-acting therapies for pediatric IRDs

Collaboration leverages PolyActiva’s PREZIA drug delivery platform to develop NCE-enabling pharmacologic drugs for early-onset vision loss.
SpyGlass Pharma reports long-term data on bimatoprost IOL system
Pipeline

SpyGlass Pharma reports long-term data on bimatoprost IOL system

Positive 36-month findings from an FIH trial and 3-month results from a phase 1/2 study support delivery of sustained IOP reduction and drop-free outcomes for OAG, OHT.
Lilly gains exclusive global rights to MeiraGTx's ophthalmic genetic therapies
Pipeline

Lilly gains exclusive global rights to MeiraGTx's ophthalmic genetic therapies

Strategic partnership extends to MeiraGTx’s investigational genetic medicine for LCA4-AIPLI-associated congenital blindness among pediatric patients.
Outlook Therapeutics resubmits wet AMD BLA for bevacizumab
Pipeline

Outlook Therapeutics resubmits wet AMD BLA for bevacizumab

Company’s third submission of ONS-5010 (bevacizumab-vikg) reportedly addresses prior issues raised in the FDA’s company response letter.
Sydnexis reports phase 3 topline data on SYD-101 eye drop for pediatric myopia
Pipeline

Sydnexis reports phase 3 topline data on SYD-101 eye drop for pediatric myopia

The STAR study met both primary and secondary endpoints for low-dose atropine formulation—just days after the FDA’s NDA rejection.
Viridian submits BLA for veligrotug to treat TED
Pipeline

Viridian submits BLA for veligrotug to treat TED

Company is requesting Priority Review of veli, an IGF-1R monoclonal antibody intravenously-administered to treat chronic TED.
Nanoscope reports 3-year vision improvements for RP optogenetic therapy
Pipeline

Nanoscope reports 3-year vision improvements for RP optogenetic therapy

Long-term extension from phase 2b/3 RESTORE trial notes potential of MCO-010 as a one-time, gene-agnostic optogenetic therapy.
FDA rejects Sydnexis’ NDA for low-dose atropine drop
Pipeline

FDA rejects Sydnexis’ NDA for low-dose atropine drop

SYD-101 still has the potential to become the first pharmaceutical option for progressive myopia for patients aged 3 to 14.
Complement Therapeutics' GA gene therapy IND receives FDA clearance
Pipeline

Complement Therapeutics' GA gene therapy IND receives FDA clearance

Clearance gives green light to begin Q1 2026 patient enrollment for the Opti-GAIN study evaluating CTx001 as a one-time, durable treatment.
Dompé receives FDA priority voucher for NAION intranasal therapy
Pipeline

Dompé receives FDA priority voucher for NAION intranasal therapy

New expedited pilot program cuts the standard application review time for investigational candidates from 10 to 12 months to just 1 to 2 months.
Nanoscope's optogenetic therapy demonstrates visual improvements for Stargardt
Pipeline

Nanoscope's optogenetic therapy demonstrates visual improvements for Stargardt

Findings from phase 2 STARLIGHT trial support the safety and efficacy of MCO-010 in Stargardt disease.
FDA grants IDE approval for Avisi's glaucoma treatment device
Pipeline

FDA grants IDE approval for Avisi's glaucoma treatment device

IDE approval enables initiation of the open-label SAPPHIRE to evaluate the VisiPlate, an aqueous shunt designed to lower IOP among OAG patients.
FDA grants Fast Track designation to Epion's EpiSmart epithelium-on CXL system
Pipeline

FDA grants Fast Track designation to Epion's EpiSmart epithelium-on CXL system

Status supports an expedited pathway toward a potential regulatory submission and approval for the minimally-invasive keratoconus treatment.