- Category: Pipeline
Pipeline
RegenxBio doses first patient in phase 2b/3 trial for DR
One-time gene therapy continues to move down the pipeline, with presentations on efficacy and safety data expected at ASRS.
Pipeline
OKYO's urcosimod gets FDA nod, moves to global phase 3 trial for NCP
Positive Type D meeting feedback supports topical therapeutic’s continued path toward becoming the first approved treatment for neuropathic corneal pain.
Pipeline
FDA grants RMAT designation to Emmecell's CED cell therapy
EO2002 is a minimally-invasive allogeneic cultured human corneal endothelial cell therapy intended to replace corneal surgery.
Pipeline
Alcon and RxSight partner to to develop light-adjustable PCIOLs
Non-exclusive deal will combine Alcon’s presbyopia-correcting IOL optical designs with RxSight’s customizable postop light-adjustable technology.
Pipeline
Oculgen enrolls first US patient in global phase 2/3 wet AMD trial
Company aims to utilize 36-week data from the STAT trial to support a BLA following its recent IND approval.
Pipeline
Ollin raises $330M to advance OLN324 in phase 3 studies for DME and wet AMD
Financing to support global clinical development of its bispecific antibody programs following promising phase 1b data readout in a head-to-head against faricimab.
Pipeline
Genentech's sBLA for subcutaneous TED therapy receives FDA priority review
Enspryng (satralizumab) has the potential to become the first at-home SC therapy to target the underlying disease with a novel mechanism of action.
Pipeline
Atsena doses first patient in phase 3 XLRS LIGHTHOUSE trial
Enrollment is expected to finish in Q1 2027, with topline results anticipated in H1 2028.
Pipeline
FDA accepts Outlook's fourth wet AMD BLA submission
The latest BLA package of ONS-5010 / LYTENAVA (bevacizumab-vikg) has received a PDUFA target action date for late July.
Pipeline
Ethyreal Bio debuts with $101M in funding to advance TED therapy
Biotech company emerges from stealth with Series B financing supporting FIH trial initiation for ETHY-001, an anti-TSHR antibody for TED and Graves’ disease.
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Belite Bio completes rolling NDA submission of oral tinlarebant for Stargardt
Next up: a 60-day review period ahead of a potential PDUFA target action date assignment; could become the first FDA-approved treatment for Stargardt.
Pipeline
Dompé kicks off patient dosing in phase 3 PCED trial on cenegermin-bkbj
Phase 3 ORUNEA trial is assessing whether targeting the biological drivers of epithelial repair can improve healing in PCED.
Pipeline
Alkeus begins dosing in global phase 3 Stargardt trial on oral gildeuretinol
Phase 3 NORTHSTAR study seeks to build on growing evidence that ALK-001 benefits low luminance visual acuity.
Pipeline
Alvotech resubmits BLA for proposed Eylea biosimilar
Follows two failed FDA facility inspections; AVT06 will now undergo a 6-month review to become the sixth biosimilar of the name-brand VEGF inhibitor.
Pipeline
FDA grants TearSolutions' NK peptide therapy two FDA designations
Investigational eye drop acts as a replacement for lacritin by restoring homeostasis to the ocular surface; phase 2 trial initiation is underway.
Pipeline
Oculis's phase 3 DME eye drop trial fails primary goals
While OCS-01 was well-tolerated, the DIAMOND program did not meet either outcome measures; company will not seek an FDA NDA filing.
Pipeline
Outlook resubmits wet AMD BLA for bevacizumab after FDA appeal win
Marks fourth attempt to secure approval for the potential first on-label bevacizumab product specifically formulated for IVT retinal use in the US.
Pipeline
Outlook Therapeutics wins FDA appeal for wet AMD BLA
Decision follows company’s challenge to its third rejected package of ONS-5010 / LYTENAVA (bevacizumab-vikg); fourth submission expected in June.
Pipeline
Lineage reports positive 36-month findings on GA cell therapy
Results from the phase 1/2a trial of OpRegen demonstrate sustained BCVA and structural improvements.
Pipeline