- Organizations: Opus GeneticsOcuphire Pharma
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.
Pipeline
Opus Genetics reports positive pediatric data from LCA5 gene therapy study
Ongoing phase 1/2 trial on OPGx-LCA5 indicates large gains in cone-mediated vision, with durable responses observed out to 18 months among adult patients.
Pipeline
Opus Genetics doses first patient in LYNX-3 phentolamine 0.75% study
Third phase 3 trial is evaluating the PF-based eye drop for chronic night driving impairment in keratorefractive patients with reduced mesopic vision.
Pipeline
FDA clears Opus Genetics' IND for BEST1 IRD gene therapy
Company plans to initiate phase 1/2 clinical trial on OPGx-BEST1, a potential first-ever treatment for this patient base.
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.
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.Pipeline
Opus Genetics reports first-in-human trial data on LCA gene therapy
One-month findings from the first of three pediatric dosings indicate a clinically meaningful improvement in vision following just one dosing.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.
Pipeline
Opus Genetics and FDA agree on SPA for phase 3 NPDR gene therapy trial
Study’s newly-established primary endpoint will support a potential new drug application submission of APX3300 for market approval.
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.
Pipeline
FDA grants Opus Genetics Rare Pediatric Disease Designation for LCA gene therapy
Designation qualifies OPGx-LCA5 to receive a priority review voucher, if approved.
Research
Foundation Fighting Blindness grants Opus Genetics $1.7M to fund IRD programs
Project-based funding will support the advancement of two preclinical trials targeting retinitis pigmentosa.
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