- Category: Pipeline
Pipeline
Opus Genetics' VEGA-3 presbyopia trial meets endpoints for phentolamine 0.75%
Topline data found a statistically significant number of patients achieved a ≥15-letter improvement in binocular DCNVA; H2 2025 NDA submission expected.
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Stuart Therapeutics reports initial phase 3 DED eye drop data
Results on ST-100 (vezocolmitide), a collagen mimetic peptide, support its role as a fast-acting resolution for dry eye signs and symptoms.
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Aldeyra resubmits reproxalap NDA for dry eye (again)
Company includes new phase 3 dry eye crossover data in updated submission package; an FDA acknowledgement response is expected within 30 days.
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FDA clears Ocugen for phase 2/3 trial on Stargardt gene therapy
IND approval enables continued clinical evaluation of OCU410ST, a modifier gene therapy with a favorable safety and tolerability profile; plans include a 2027 BLA submission.
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Qlaris Bio developing fixed-dose latanoprost and QLS-111 eye drop for glaucoma
New combination therapy involving the prostaglandin analog targets lowering episcleral venous pressure to lower IOP.
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SpyGlass Pharma raises $75M to advance sustained-release drug delivery platform
Financing to support upcoming phase 3 trials on the company’s long-term delivery system of bimatoprost for glaucoma and OHT treatment.
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FDA clears IND for Zhaoke Ophthalmology's CsA ophthalmic gel
Clearance paves the way for a new phase 3 trial to evaluate CsA 0.05% for its safety and efficacy among moderate-to-severe DED patients—with plans for an eventual NDA submission.
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ViGeneron rebrands as VeonGen Therapeutics with new FDA designation
German-based genetic medicine company also receives a Rare Pediatric Disease Designation for its Stargardt disease gene therapy candidate.
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iVeena submits IND to FDA for pediatric myopia clinical trial
Company plans to initiate a multinational phase 2 study on IVMED-85, a PF and non-atropine daily eye drop intended to improve refraction and decrease AE rates.
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FDA accepts Tenpoint's Brimochol PF NDA for presbyopia
Fixed-dose-combo eye drop of brimonidine tartrate and carbachol has demonstrated a statistically significant reduction in pupil size up to 10 hours; PDUFA date set for January.
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Opus Genetics reports positive phase 3 data for phentolamine 0.75%
Topline findings indicate the gene therapy achieved a ≥15-letter (≥3-line) gain in mesopic low contrast distance visual acuity versus placebo.
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FDA grants Rare Pediatric Disease designation to Stargardt gene therapy
OCU410ST could receive a priority review voucher if approved; company plans to initiate a phase 2/3 trial in coming weeks—along with a BLA filing in 2027.
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New DOT lens data finds 75% pediatric myopia management efficacy after 12 months
Latest clinical results support safety and effectiveness of SightGlass Vision’s Diffusion Optics Technology spectacle lenses—including 1-year following discontinued wear.
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Allotex submits IDE to FDA for collagen-based corneal implant
Company is seeking to conduct a U.S. clinical trial on its tissue addition technology procedure that augments the cornea using precision-shaped human collagen.
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Viridian reports long-term durability data, secures FDA designation for TED therapy
After receiving FDA Breakthrough Therapy designation, new 52-week data finds 70% of proptosis responders at Week 15 maintained their response.
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FDA clears Selagine's immunoglobulin DED drops for phase 2 trial
IND approval supports clinical development and evaluation of the anti-inflammatory and immunomodulatory biologic drug, potentially the first of its kind in the U.S.
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FDA OKs clinical trial on Atia Vision's novel IOL for cataract patients
IDE approval brings company one step closer toward seeking regulatory clearance for the OmniVu Lens System, a dual-optic IOL.
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Atsena releases favorable LIGHTHOUSE trial data on XLRS gene therapy
Positive findings from 1-year post-treatment show meaningful improvements on visual function measurements, with foveal schisis closure observed in 67% of patients.
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Nicox releases favorable phase 3b data on IOP-lowering glaucoma therapeutic
Exploratory Whistler trial reports statistically significant IOP lowering and uveoscleral outflow for NCX 470, an NO-donating bimatoprost formulation.
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