- organizations:Ocuphire Pharma
Business
Ocuphire Pharma just purchased Opus Genetics
Operating under the name “Opus Genetics,” the combined company features a pipeline of IRD-targeted gene therapy candidates.
Products
Ocuphire reports favorable phase 3 data on RYZUMVI
Phentolamine ophthalmic solution 0.75% demonstrates rapid reversal of pharmacologically-induced mydriasis in newly published findings.
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.
Research
Ocuphire releases post-hoc phase 2 data on DR oral supplement
Presented at ARVO, results from an analysis of the ZETA-1 trial demonstrate favorable safety and tolerability for oral supplementation.
Pipeline
Ocuphire enrolls first patient in LYNX-2 phase 3 study for phentolamine
Trial is evaluating phentolamine ophthalmic solution 0.75% (PS) for decreased VA under low (mesopic) light conditions after keratorefractive surgery.Products
Viatris launches RYZUMVI in the United States
As the first and only commercially available treatment for reversal of mydriasis (RM), the eye drop is now available through four distributors.
Pipeline
FDA grants SPA agreement to Ocuphire for phase 3 trial on phentolamine solution
LYNX-2 study is anticipated to begin enrollment in Q1 2024 for the treatment of dim light or night vision disturbances.
Business
Ocuphire Pharma names new CEO
Effective November 1, the search has ended 5 months after sacking its previous CEO.
Products
FDA approves Ocuphire and Viatris's RYZUMVI for RM
RYZUMVI is now the only commercially available treatment option in the U.S. indicated for the reversal of mydriasis (RM).
Business
Ocuphire Pharma ousts CEO; names interim leader
Rick Rodgers will serve as CEO on an interim basis.
Pipeline
FDA accepts Ocuphire NDA for Nyxol to treat RM
A PDUFA target action date has been set for later this fall.
Pipeline
Ocuphire releases topline data from phase 2 trial for DR
Results from the ZETA-1 trial of oral APX330 demonstrate favorable safety and tolerability.
Research
First patient enrolled in pivotal phase 3 trial of Nyxol for presbyopia
Ocuphire Pharma's VEGA-2 phase 3 trial is evaluating Nyxol for single use and in combination with low-dose (0.4%) pilocarpine.
Archives
Are those dilation reversal drops available yet? — Weekly Glance
Not quite, but we have an update!
Pipeline
Ocuphire submits NDA to FDA for Nyxol
Ocuphire is seeking an NDA for Nyxol for the reversal of pharmacologically-induced mydriasis.
Business