• Category: Pipeline
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.
SightGlass unveils 18-month data on DOT spectacle lenses for myopia
Pipeline

SightGlass unveils 18-month data on DOT spectacle lenses for myopia

Latest findings follow 12-month data reported at ARVO; results show over 50% of pediatric patients had no clinically meaningful disease progression.
Oculis advances neuro-ophthalmic asset after positive FDA feedback
Pipeline

Oculis advances neuro-ophthalmic asset after positive FDA feedback

Privosegtor (OCS-05) gets the green light to be studied in registrational trials beginning this quarter for acute optic neuritis and NAION in 2026.
FDA grants Orphan Drug designation to AAVantgarde's Stargardt gene therapy
Pipeline

FDA grants Orphan Drug designation to AAVantgarde's Stargardt gene therapy

Regulatory milestone is second designation for AAVB-039; includes tax credits for qualified clinical testing and, if approved, seven years of U.S. market exclusivity.
Opus Genetics reports positive pediatric data from LCA5 gene therapy study
Pipeline

Opus Genetics reports positive pediatric data from LCA5 gene therapy study

Ongoing phase 1/2 trial on OPGx-LCA5 indicates large gains in cone-mediated vision, with durable responses observed out to 18 months among adult patients.
FDA grants Breakthrough Therapy Designation to Nacuity's RP tablets
Pipeline

FDA grants Breakthrough Therapy Designation to Nacuity's RP tablets

Third designation for NPI-001 follows recent positive 24-month data showing a 50% photoreceptor reduction after 2 years of daily dosing.
Kala's phase 2b PCED trial fails to meet primary goal
Pipeline

Kala's phase 2b PCED trial fails to meet primary goal

Company plans to cease development of lead asset KPI-012 as the CHASE study also falls short of achieving statistical significance for secondary endpoints.