- Category: Pipeline
- Tags: presbyopia
Pipeline
FDA accepts sNDA of phentolamine 0.75% for presbyopia
Already FDA-approved and commercially available as RYZUMVI, the eye drop has been assigned a PDUFA date of Oct. 17, 2026.
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FDA clears Cloudbreak Pharma's IND for phase 2 presbyopia drop trials
Clearance green lights advancement of CBT-199, an ophthalmic emulsion with a proprietary, water-free formulation and parasympathomimetic miotic agent.
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FDA approves Allotex's IDE for US study of tissue-based solution for presbyopia
Company gets all-clear for clinical trial on its tissue addition technology and customized, laser-shaped human corneal tissue to restore vision.
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LENZ and Théa partner on Canadian commercialization of presbyopia eye drop
Licensing and commercialization agreement gives LENZ $70 million in upfront and milestone payments; news comes as company awaits FDA approval.
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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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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
Tenpoint submits NDA for Brimochol PF for presbyopia
The FDA begins a 60-day review period to determine if the submission for the pupil-modulating eye drop is acceptable.Pipeline
Tenpoint reports positive topline data from phase 3 presbyopia eye drop study
With BRIMOCHOL PF meeting its prespecified primary endpoints, the company is planning for a regulatory filing within the first half of 2025.
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Lenz Therapeutics and Corxel release positive phase 3 presbyopia data from China
Statistically significant topline data supports LNZ100’s safety profile just days after the FDA accepts LENZ’s NDA for potential U.S. regulatory approval.
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FDA accepts Lenz Therapeutics’ NDA for presbyopia eye drops
PDUFA target action date on LNZ100 (1.75% aceclidine) is set for August 2025
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Ocuphire doses first patient in phase 3 presbyopia study on phentolamine solution
Already FDA approved as RYZUMVI for reversal of mydriasis, VEGA-3 topline data on POS 0.75% is expected by early 2025.
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Lenz Therapeutics submits NDA for presbyopia eye drop
FDA has 60 days to review LNZ100 (1.75% aceclidine) as a pupil-selective and long-lasting therapeutic option.
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LENZ Therapeutics reports positive phase 3 data for presbyopia eye drops
CLARITY 1 and 2 trials report statistically significant topline data for single-use, once-daily, and preservative-free LNZ100.
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Lenz raises millions in financing for advancement of presbyopia trials
Phase 3 CLARITY program launched in December 2022 with three parallel trials.
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Visus completes enrollment for phase 3 trial of Brimochol PF for presbyopia
Pivotal study is assessing safety and efficacy of the combined, fixed-dosage of carbachol and brimonidine tartrate.
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FDA accepts Orasis NDA for CSF-1 to treat presbyopia
A PDUFA target action date has been set for later this fall.
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Orasis Pharmaceuticals submits NDA for CSF-1 for the treatment of presbyopia
Could a new presbyopia drug be coming?
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TECLens study treats first patient for noninvasive refractive vision correction
First-in-human trial is evaluating the in-office qCXL technology as an alternative to traditional refractive surgical procedures for strengthening corneal integrity.
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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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