• category:Pipeline
Positive 6-month results reported in OASIS extension trial for CLS-AX
Pipeline

Positive 6-month results reported in OASIS extension trial for CLS-AX

Latest data finds a 77% to 85% reduction in treatment burden over time period.
FDA clears HuidaGene for IND, multi-national IRD trial
Pipeline

FDA clears HuidaGene for IND, multi-national IRD trial

Company plans to analyze HG004 as treatment for patients with inherited retinal dystrophies linked to the RPE65 mutations.
Prototype designed to prevent contact lens-induced dry eye
Pipeline

Prototype designed to prevent contact lens-induced dry eye

New contact lens prototype targets ocular dryness via tear flow.
FDA accepts Oxular’s IND for DME treatment
Pipeline

FDA accepts Oxular’s IND for DME treatment

Pre-clinical data shows OXU-001 can provide up to 12 months of tolerability with just a single administered dose.
Ocuphire releases topline data from phase 2 trial for DR
Pipeline

Ocuphire releases topline data from phase 2 trial for DR

Results from the ZETA-1 trial of oral APX330 demonstrate favorable safety and tolerability.
Short-term data reported in case series of SING IMT for AMD
Pipeline

Short-term data reported in case series of SING IMT for AMD

Safety and efficacy outcomes show 3-month data from the first and largest single-surgeon cases series.
Horizon releases phase 2 trial results of dazodalibep for Sjögren’s syndrome
Pipeline

Horizon releases phase 2 trial results of dazodalibep for Sjögren’s syndrome

The second of two population studies met its primary endpoint.
First patient dosed in phase 1 study for CED treatment
Pipeline

First patient dosed in phase 1 study for CED treatment

Trial is assessing Trefoil Therapeutics’ lead investigational candidate: TTHX114.
Positive data for Glaukos’s iDose TR exchange trial
Pipeline

Positive data for Glaukos’s iDose TR exchange trial

Results highlight favorable safety and tolerability for the IOP-lowering implant.
Eyenovia releases positive data on Optejet delivery system for glaucoma treatment
Pipeline

Eyenovia releases positive data on Optejet delivery system for glaucoma treatment

New study compares effectiveness of glaucoma medication administered via the company’s delivery system versus standard or conventional drops.
Glaukos reports positive clinical data for phase 2a first-in-human DED trial
Pipeline

Glaukos reports positive clinical data for phase 2a first-in-human DED trial

Topline data shows promising results for investigational drug GLK-301, a patent cream-based formulation.
Positive topline phase 2 data reported for PCED treatment
Pipeline

Positive topline phase 2 data reported for PCED treatment

A total of 67% of subjects receiving NEXAGON achieved complete epithelial recovery.
Opus Genetics acquires rights to Iveric Bio gene therapy candidates
Pipeline

Opus Genetics acquires rights to Iveric Bio gene therapy candidates

Deal builds on the company’s existing portfolio of AAV-based gene therapies for inherited retinal diseases.
Orasis Pharmaceuticals submits NDA for CSF-1 for the treatment of presbyopia
Pipeline

Orasis Pharmaceuticals submits NDA for CSF-1 for the treatment of presbyopia

Could a new presbyopia drug be coming?
FDA accepts Kala Pharmaceuticals’ IND application for PCED treatment
Pipeline

FDA accepts Kala Pharmaceuticals’ IND application for PCED treatment

The company plans on initiating enrollment for a phase 2b trial this quarter.
Aldeyra submits NDA for primary vitreoretinal lymphoma treatment
Pipeline

Aldeyra submits NDA for primary vitreoretinal lymphoma treatment

ADX-2191 has already received Orphan Drug and Fast Track designation from the FDA.
Iveric Bio completes NDA submission of Zimura
Pipeline

Iveric Bio completes NDA submission of Zimura

Zimura is the first and currently only therapy to receive Breakthrough Therapy Designation for GA secondary to AMD.
FDA accepts Eyenovia’s NDA for MydCombi for in-office mydriasis
Pipeline

FDA accepts Eyenovia’s NDA for MydCombi for in-office mydriasis

A PDUFA action target date is set for May 8, 2023.
FDA approves Théa Pharma’s Iyuzeh for glaucoma
Pipeline

FDA approves Théa Pharma’s Iyuzeh for glaucoma

The new approval targets patients with elevated IOP in OAG and ocular hypertension.
FDA grants 510(k) clearance for Bausch + Lomb’s Biotrue contact lens rehydrating drops
Pipeline

FDA grants 510(k) clearance for Bausch + Lomb’s Biotrue contact lens rehydrating drops

Drops provide moisture instantly and up to 8 hours after installation.