- Category: Pipeline
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.
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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.
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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.
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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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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.
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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.
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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.
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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.
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