- Tags: presbyopia
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.
Products
Orasis's QLOSI for presbyopia launches in the US
Pilocarpine 0.4% provides patients with flexible dosing for up to 8 hours of clear near vision; prescription-based drops are available through two pharmacy partners.
Products
Hoya introduces VisuPro All Day and Flex lenses for young presbyopes
Advanced spectacle lenses target adult patients experiencing an initial gradual loss of vision.
Products
Alcon launches Clareon PanOptix Pro IOL in the US
With a broad commercial rollout planned for next month, this will be the company’s first presbyopia-correcting IOL available in its Clareon AutonoMe preloaded system.
Business
Tenpoint Therapeutics names veteran executive as first CCO
Carol Kearney to lead company’s efforts to launch and expand global availability of BRIMOCHOL PF for presbyopia.
Pipeline
Opus Genetics receives Fast Track designation, reports phase 3 updates for phentolamine solution
VEGA-3 and LYNX-2 trials report completion and near completion of patient enrollment evaluating POS 0.75% for presbyopia and visual loss in low light conditions associated with keratorefractive surgery, respectively.
Business
TECLens raises $9.3M in funding for non-invasive refractive tech
The company's corneal CXL-based, non-incisional refractive correction procedure is designed to reshape the corneal for presbyopes and myopes.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.
Business
Tenpoint and Visus Therapeutics merge with plans for ophthalmic therapeutic advancements
Newly-combined Tenpoint Therapeutics, Ltd includes a pipeline featuring BRIMOCHOL PF, a once-daily eye drop for presbyopia targeting an NDA filing in 2025.
Pipeline
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.
Pipeline
FDA accepts Lenz Therapeutics’ NDA for presbyopia eye drops
PDUFA target action date on LNZ100 (1.75% aceclidine) is set for August 2025
Products
FDA approves Bausch + Lomb's en Vista Envy IOL
Offering a continuous range of vision with excellent dysphotopsia tolerance, the lens will be initially available on a limited basis.Products
Orasis secures financing to support US commercial launch of Qlosi
With $78 million in Series D financing, the preservative-free pilocarpine solution is one step closer to availability.
Products
J&J expands US rollout of TECNIS Odyssey IOL
Purely refractive presbyopia-correcting lens provides full visual range with minimal visual complaints and higher tolerance to residual refractive errors.
Pipeline
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.
Pipeline
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.
Pipeline
Refractive tech startup TECLens gets J&J investment
Private medical device company’s corneal cross-linking technology operates as a non-invasive, in-office treatment for keratoconus and progressive pediatric myopia.
Events
Experts weigh in on key trends in anterior segment innovations
Ophthalmic leaders cover market opportunities, bridging the gap between physicians and industry, as well as premium patient outcomes for the future.
Products
Bausch + Lomb's enVista Envy IOL secures Canadian approval
Acceptance marks first global regulatory approval for the new lens; company notes FDA approval is pending.
Pipeline