• Category: Pipeline
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.
Pandorum Tech raises $18M to expand operations for bioengineered cornea
Pipeline

Pandorum Tech raises $18M to expand operations for bioengineered cornea

Financing to advance biotech’s ‘liquid-based cornea’ Kuragenx, an eye drop bioengineered to revert an ulcerative cornea to its healthy state in less than 1 year.
4DMT completes enrollment for phase 3 wet AMD gene therapy trial
Pipeline

4DMT completes enrollment for phase 3 wet AMD gene therapy trial

4FRONT-1 study is evaluating 4D-150 as a single, low-dose IVT injection among treatment-naïve wet AMD patients; topline data expected in H1 2027.
First patient treated with Calibreye System in IDE glaucoma study
Pipeline

First patient treated with Calibreye System in IDE glaucoma study

The ADAPT trial is evaluating Myra Vision’s next-gen aqueous shunt drainage device for optimizing IOP reduction in patients undergoing glaucoma surgery.
FDA grants Fast Track designation for Drug Farm's ROSAH syndrome asset
Pipeline

FDA grants Fast Track designation for Drug Farm's ROSAH syndrome asset

Status enables expedited regulatory review process for DF-003, designed to target the genetic root cause of this rare genetic disease.
FDA clears Novaliq's IND for NIAU phase 2 trial
Pipeline

FDA clears Novaliq's IND for NIAU phase 2 trial

Clearance enables FIH study of potentially the first steroid-free eye drop for controlling IOI among non-infectious anterior uveitis patients.
Novartis's ianalumab earns FDA Breakthrough Therapy designation for Sjögren’s disease
Pipeline

Novartis's ianalumab earns FDA Breakthrough Therapy designation for Sjögren’s disease

Fully human monoclonal antibody is delivered as a monthly subcutaneous injection; company plans to submit for global approval in early 2026.
FDA grants Orphan Drug designation to BlueRock's RP cell therapy
Pipeline

FDA grants Orphan Drug designation to BlueRock's RP cell therapy

Marks second designation for OpCT-001; includes tax credits for qualified clinical testing and, if approved, 7 years of U.S. market exclusivity.
BioAge Labs expands into DME clinical program for oral inhibitor asset
Pipeline

BioAge Labs expands into DME clinical program for oral inhibitor asset

Preclinical evidence on NLRP3 inhibitor BGE-102 shows potential for therapeutic retinal exposure, with an initial POC trial to kick off later this year.
TheiaNova doses first patient in FIH trial on regenerative eye drop for keratoconus
Pipeline

TheiaNova doses first patient in FIH trial on regenerative eye drop for keratoconus

Study to evaluate TN-001, formulated to reprogram corneal cells and rebuild the cornea— preventing further corneal distortion and visual deterioration.
Nanoscope secures US patent for MCO optogenetic tech platform
Pipeline

Nanoscope secures US patent for MCO optogenetic tech platform

U.S. IP protections now in effect through 2039 as the company continues rolling BLA submission of MCO-010 for restoring vision loss in RP patients.
Complement Therapeutics secures Fast Track Designation for lead GA therapy
Pipeline

Complement Therapeutics secures Fast Track Designation for lead GA therapy

AAV-based CTx001 modulates multiple pathways of the complement system when delivered as a one-time, subretinal injection.
FDA approves Allotex's IDE for US study of tissue-based solution for presbyopia
Pipeline

FDA approves Allotex's IDE for US study of tissue-based solution for presbyopia

Company gets all-clear for clinical trial on its tissue addition technology and customized, laser-shaped human corneal tissue to restore vision.
Aviceda releases phase 2b topline data on AVD-104 for GA
Pipeline

Aviceda releases phase 2b topline data on AVD-104 for GA

Latest SIGLEC trial results show both dosing arms with 31% to 38% less lesion growth than prior trials; phase 3 plans are underway.
FDA grants Breakthrough Therapy Designation to Oculis' privosegtor for optic neuritis
Pipeline

FDA grants Breakthrough Therapy Designation to Oculis' privosegtor for optic neuritis

The neuroprotective candidate is currently being studied in the global PIONEER clinical program for both acute ON and NAION.