- Category: Pipeline
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.
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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.
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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.
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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.
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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.
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Viridian Therapeutics releases topline phase 3 TED data elegrobart
Subcutaneous IGF-IR has potential to be the first autoinjector treatment for TED; BLA submission on track for Q1 2027
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Preliminary data evaluates Astellas's RPE cell therapy for advanced GA
Presented at ARVO 2026, early 26- and 52-week safety phase 1b data from highlights notable visual gains in patients receiving ASP7317.
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FDA agrees to special protocol assessment for Oculis’s phase 3 ON trial
Agreement on the PIONEER-1 study offers regulatory alignment on privosegtor’s registration path as a potential neuroprotective candidate.
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Atsena releases positive XLRS interim data from LIGHTHOUSE study
Enrollment for Part C of the study is underway, with the company targeting a 2028 BLA submission for ATSN-201, an investigational gene therapy.
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New SightGlass 24-month data shows DOT lenses significantly slow pediatric myopia progression
Unveiled at ARVO 2026, DOT lenses saved more than 1 D of myopic progression on average after 2 years among 6-to-10-year-old wearers.Pipeline
Oculis reports final phase 3 patient visit for DME eye drops
Topline data on OCS-01 from DIAMOND program expected in June 2026 with the goal of supporting an NDA submission in Q4 2026.
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MeiraGTx acquires J&J's XLRP investigational therapy
Deal includes all interests in botaretigene sparoparvovec (bota-vec); company plans to immediately file for global regulatory approval.
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Belite Bio begins rolling NDA submission of oral tinlarebant for Stargardt
Full submission planned for Q2 2026, once-daily tablet has potential to become the first-ever treatment approved for this patient base.
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Merck kicks off phase 2b/3 trial on tri-specific antibody for wet AMD
Merck initiates next phase of clinical testing in ophthalmology with two candidates targeting nAMD and DME.
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Ocular Therapeutix releases additional phase 3 AXPAXLI data for wet AMD
Data from SOL-1 phase 3 data will become the basis of a planned NDA submission in near future.Pipeline
FDA accepts Outlook Therapeutics' request over rejected wet AMD BLA
Company challenges decision on failed third submission package of ONS-5010 / LYTENAVA (bevacizumab-vikg), with a decision expected in May.
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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.
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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.
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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.
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