• Category: Pipeline
Aurion Biotech begins dosing in phase 3 trial on allogeneic cell therapy for CED
Pipeline

Aurion Biotech begins dosing in phase 3 trial on allogeneic cell therapy for CED

The ASTRA study kicks off evaluating AURN001, designed to regenerate corneal clarity and vision through an intracameral injection.
i-Lumen Scientific earns FDA IDE clearance for dry AMD trial
Pipeline

i-Lumen Scientific earns FDA IDE clearance for dry AMD trial

Biotech company is expanding the global i-SIGHT 2 pivotal trial evaluating its non-invasive bioelectric stimulation therapy as an in-office treatment.
Sydnexis's low-dose atropine shows strong phase 3 efficacy for pediatric myopia
Pipeline

Sydnexis's low-dose atropine shows strong phase 3 efficacy for pediatric myopia

Recent 3-year data from the STAR trial meets primary and secondary endpoints for SYD-101, including the greatest treatment benefits among younger myopes.
FDA grants RMAT designation to Ray Therapeutics' RP optogenetic therapy
Pipeline

FDA grants RMAT designation to Ray Therapeutics' RP optogenetic therapy

RTx-015 is a single, IVT-administered therapeutic designed to restore vision by converting surviving neurons into photo-sensing cells.
FDA grants Orphan Drug Designation to SignaBlok's ROP therapy
Pipeline

FDA grants Orphan Drug Designation to SignaBlok's ROP therapy

TREM-1 inhibitor is designed to selectively target inflammation via a noninvasive delivery; company plans to report preclinical data at ARVO annual meeting.
Viridian releases phase 3 topline data on elegrobart for TED
Pipeline

Viridian releases phase 3 topline data on elegrobart for TED

REVEAL-1 meets primary goals, with the subcutaneous IGF-1R monoclonal antibody showing rapid and clinically meaningful reductions in proptosis and diplopia.
Kodiak reports positive phase 3 data on tarcocimab for DR
Pipeline

Kodiak reports positive phase 3 data on tarcocimab for DR

Topline findings from the GLOW2 trial indicate Zenkuda’s superiority over sham as company plans for a multi-indication FDA filing.
Lineage Cell Therapeutics launches new CED cell therapy program
Pipeline

Lineage Cell Therapeutics launches new CED cell therapy program

Preclinical candidate COR1 is designed as an allogeneic source of corneal endothelial cells to replace damaged cells and restore corneal function.
Complement Therapeutics begins patient dosing in GA gene therapy trial
Pipeline

Complement Therapeutics begins patient dosing in GA gene therapy trial

Opti-GAIN trial is evaluating a single subretinal injection of CTx-001, an AAV-based gene therapy modulating multiple pathways of the complement system.
Positive 24-month data supports the Elios System for glaucoma treatment
Pipeline

Positive 24-month data supports the Elios System for glaucoma treatment

Microinvasive, implant-free procedure used excimer laser technology to lower IOP by 20% or greater among 76% of glaucoma and cataract patients
FDA issues third CRL to Aldeyra, rejecting reproxalap NDA
Pipeline

FDA issues third CRL to Aldeyra, rejecting reproxalap NDA

Agency notes a lack of substantial evidence, failure to demonstrate efficacy, and inconsistent study results in latest dismissal of the DED eye drop.
FDA rejects Chiesi Group's NDA for LHON oral drug
Pipeline

FDA rejects Chiesi Group's NDA for LHON oral drug

Agency issues company response letter citing a need for additional clinical data, further demonstrating idebenone’s safety and effectiveness.
ReVision Implant secures FDA Breakthrough Device Designation for visual cortical prosthesis
Pipeline

ReVision Implant secures FDA Breakthrough Device Designation for visual cortical prosthesis

The Occular system is designed to capture visual data via a camera-mounted wireless headset—potentially restoring visual function in blind patients.
TECLens study treats first patient for noninvasive refractive vision correction
Pipeline

TECLens study treats first patient for noninvasive refractive vision correction

First-in-human trial is evaluating the in-office qCXL technology as an alternative to traditional refractive surgical procedures for strengthening corneal integrity.
EyePoint begins dosing in phase 3 DME trials for DURAVYU
Pipeline

EyePoint begins dosing in phase 3 DME trials for DURAVYU

COMO and CAPRI pivotal studies are evaluating vorolanib insert when intravitreally-injected every 6 months; topline data expected H2 2027.
FDA accepts sNDA of phentolamine 0.75% for presbyopia
Pipeline

FDA accepts sNDA of phentolamine 0.75% for presbyopia

Already FDA-approved and commercially available as RYZUMVI, the eye drop has been assigned a PDUFA date of Oct. 17, 2026.
New FDA policy shifts to single pivotal trial standard for NDAs
Pipeline

New FDA policy shifts to single pivotal trial standard for NDAs

New guidance ends a long-standing reliance on the “two-trial dogma,” potentially lowering capital costs for drug developers and prices for patients.
Ocular Therapeutix reports positive phase 3 SOL-1 superiority data for wet AMD
Pipeline

Ocular Therapeutix reports positive phase 3 SOL-1 superiority data for wet AMD

AXPAXLI is the first and only novel drug to demonstrate superiority to an approved anti-VEGF treatment in an FDA-aligned wet AMD study.
Nicox reports positive pre-NDA FDA meeting for IOP-lowering drop
Pipeline

Nicox reports positive pre-NDA FDA meeting for IOP-lowering drop

NO-donating bimatoprost formulation remains on track for a summer 2026 new drug application submission.
FDA clears Cloudbreak Pharma's IND for phase 2 presbyopia drop trials
Pipeline

FDA clears Cloudbreak Pharma's IND for phase 2 presbyopia drop trials

Clearance green lights advancement of CBT-199, an ophthalmic emulsion with a proprietary, water-free formulation and parasympathomimetic miotic agent.