- Category: Pipeline
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
ViGeneron rebrands as VeonGen Therapeutics with new FDA designation
German-based genetic medicine company also receives a Rare Pediatric Disease Designation for its Sargardt disease gene therapy candidate.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
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.
Pipeline
EyeCool reports favorable safety data on COSP investigational device
Topline findings indicate a significant reduction in patient-reported ocular surface pain scores following targeted delivery of thermal energy.
Pipeline
Favorable safety data supports Alkeus' oral gildeuretinol for dry AMD
Presented during ARVO 2025, the modified form of Vitamin A demonstrated a slower decline in vision-related quality of life among patients diagnosed with GA secondary to AMD.
Pipeline