- Category: Pipeline
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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FDA rejects Outlook Therapeutics' third BLA submission of bevacizumab for wet AMD
Agency cites need for confirmatory evidence of efficacy as reason for latest CRL; ONS-5010 is already approved in the EU and UK as LYTENAVA.
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FDA accepts Viridian's veligrotug BLA for TED
Therapeutic also receives priority review, enabling a PDUFA target action date for the end of June 2026.
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What to keep an eye on in 2026
A new year means new clinical data and NDA submissions—get the full rundown.
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FDA extends reproxalap's PDUFA to March 2026
Updated target action date applies to Aldeyra’s third NDA submission of the investigational DED eye drop.
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OKYO Pharma reports favorable phase 2 data for NCP asset
Formerly OK-101, urcosimod is formulated for topical application, with latest results demonstrating a favorable impact on corneal nerve health.
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Cloudbreak advances vascularized pinguecula eye drop to phase 3 trials
Company’s investigational multi-kinase inhibitor targeting VEGFs and PD-GFRs met phase 2 primary endpoint of conjunctival hyperemia earlier this year
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Azura gets positive FDA feedback on NDA submission for MGD ointment
Positive pre-NDA meeting for selenium sulfide ointment precedes planned phase 3 data release in Q1 2026 and regulatory submission in H2 2026.
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SeaBeLife and Unither to formulate and develop retinal degenerative disorder formulation
Collaboration focuses on accelerating development of SBL03, formulated for topical delivery to target retinal cell necrosis in GA and dry AMD.
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Ocular Therapeutix plans for NDA submission of AXPAXLI for wet AMD
Company expects to submit package in Q1 2026, following the anticipated release of positive 1-year data from the phase 3 SOL-1 trial.
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EyeYon Medical secures IDE approval for study on first artificial endothelial layer
IDE approval allows for clinical study initiation to evaluate EndoArt, the first-ever synthetic implant for treating corneal edema and improving vision.
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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.
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