Nyxol (phentolamine mesylate ophthalmic solution 1%) / Opus Genetics - LARVOL DELTA

Opus Genetics Announces Presentation on Phentolamine Ophthalmic Solution 0.75% in Dim Light Disturbances at World Cornea Congress IX (GlobeNewswire) - P3 | N=144 | LYNX-1 (NCT04638660) | Sponsor: Ocuphire Pharma, Inc. | "As previously reported, the LYNX-1 Phase 3 study met its primary endpoint, with a statistically significant greater percentage of Phentolamine Ophthalmic Solution 0.75%-treated participants gaining 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8, compared to placebo (13% vs. 3%; p<0.05). The effect of Phentolamine Ophthalmic Solution 0.75% increased at Day 15, with 21% of participants gaining 15 or more letters of mLCVA compared to 3% of participants given the placebo (p<0.01). Patient reported outcomes for glare, halos, and starbursts were significantly lower for the Phentolamine Ophthalmic Solution 0.75% group compared to placebo at Day 15 (p<0.01)...LYNX-2 is fully enrolled, with topline results expected mid 2025."

P3 data • P3 data: top line • Ophthalmology

VEGA-3: Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia (clinicaltrials.gov) - P3 | N=545 | Active, not recruiting | Sponsor: Ocuphire Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

LYNX-2: Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects with Post-refractive Surgery Visual Disturbances (clinicaltrials.gov) - P3 | N=200 | Active, not recruiting | Sponsor: Ocuphire Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

Opus Genetics Announces Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting (GlobeNewswire) - "Opus Genetics, Inc...today announced that three abstracts on its investigational gene therapy candidates have been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting, to take place May 4-8, 2025 in Salt Lake City, UT. The abstracts feature 12-month data from the first three adult patients in our ongoing Phase 1/2 trial of OPGx-LCA5, as well as pre-clinical results on OPGx-MERTK and OPGx-RDH12. An abstract summarizing a subset analysis from the previously completed LYNX-1 Phase 3 trial of Phentolamine Ophthalmic Solution 75% has also been accepted for presentation...Previously announced results showed OPGx-LCA5 to be well tolerated, with all three adult patients showing visual improvement at six months. New data from the study, to be presented at ARVO, show that subjective and objective signs of efficacy persisted for a year."

P1/2 data • P3 data • Preclinical • Genetic Disorders • Ophthalmology • Rare Diseases • Retinal Disorders • Retinitis Pigmentosa

Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine Ophthalmic Solution 0.75% Programs (GlobeNewswire) - "Opus Genetics, Inc...today announced completion of enrollment in the VEGA-3 Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for presbyopia. Opus also announced that enrollment in the LYNX-2 pivotal Phase 3 trial, evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of visual loss in low light conditions associated with keratorefractive surgery, is well-underway with anticipated completion of enrollment in the first half of 2025. In addition, the FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% as treatment of significant chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (i.e., glare, halos, starburst)."

Enrollment status • Fast track • Ophthalmology

VEGA-3: Evalyate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia (clinicaltrials.gov) - P3 | N=545 | Recruiting | Sponsor: Ocuphire Pharma, Inc.

New P3 trial • Ophthalmology

LYNX-2: Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Ocuphire Pharma, Inc.

New P3 trial • Surgery • Ophthalmology

VEGA-2: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (clinicaltrials.gov) - P3 | N=333 | Completed | Sponsor: Ocuphire Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

Ocuphire Pharma to Present at ESCRS 2023 and MODLive! Conferences in September (GlobeNewswire) - "Ocuphire Pharma, Inc...today announced that it will present clinical data on APX3330 and Nyxol at the 41st Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) to take place September 8th - 11th, in Vienna, Austria."

Clinical data • P2 data • P3 data • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Ocuphire Pharma Announces Financial Results for Second Quarter 2023 and Provides Corporate Update (Yahoo Finance) - "Research and development expenses for the three and six months ended June 30, 2023 were $4.7 million and $10.3 million, respectively, compared to $3.2 million and $7.9 million, respectively, for the three and six months ended June 30, 2022. The increases from the comparable periods in 2022 were primarily attributable to increased clinical costs of for Nyxol and APX3330 period over period as well as increased consulting and other costs during the current period."

Commercial • CNS Disorders • Diabetic Macular Edema • Diabetic Retinopathy • Inflammatory Bowel Disease • Ophthalmology • Pain • Peripheral Neuropathic Pain

VEGA-2: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (clinicaltrials.gov) - P3 | N=320 | Active, not recruiting | Sponsor: Ocuphire Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

Ocuphire Announces APX3330 and Nyxol Data Presentations at ASCRS 2023 and Eyecelerator (GlobeNewswire) - "Ocuphire Pharma, Inc...announced presentations featuring results from the Company’s recently completed trials of APX3330 and Nyxol® at the American Society of Cataract and refractive Surgery (ASCRS) to be held in San Diego, CA May 5-8, 2023. In addition, Ocuphire, represented by Chief Medical Advisor Jay Pepose M.D., Ph.D, will also be featured in the Marketplace Company Showcase at Eyecelerator @ ASCRS 2023 on May 4."

Clinical data • Diabetic Retinopathy • Glaucoma • Ophthalmology

Ocuphire Announces APX3330 and Nyxol Data Presentations at ARVO 2023 Annual Meeting (GlobeNewswire) - "Oral Presentation to Feature Results from ZETA-1 Phase 2 Trial of APX3330 in Diabetic Retinopathy Patients; Results from Phase 3 LYNX-1 Trial of Nyxol® in Dim Light Vision Disturbance to be Presented for the First Time to the Medical Community...Ocuphire Pharma...announced five presentations featuring results from the Company’s recently completed trials of APX3330 and Nyxol at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, to take place in New Orleans, LA from April 23 to April 27, 2023."

Clinical data • P2 data • P3 data • Diabetic Retinopathy • Glaucoma • Ophthalmology

VEGA-2: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (clinicaltrials.gov) - P3 | N=320 | Recruiting | Sponsor: Ocuphire Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology

Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date of September 28, 2023 for Nyxol Eye Drops for Reversal of Mydriasis (GlobeNewswire) - "Ocuphire Pharma...today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nyxol® (phentolamine ophthalmic solution 0.75%) for the treatment of pharmacologically-induced mydriasis (RM). The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of September 28, 2023....The NDA filing is supported by positive results from the comprehensive MIRA clinical program collectively involving over 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial."

NDA • PDUFA date • Glaucoma • Ophthalmology

VEGA-2: Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia (clinicaltrials.gov) - P3 | N=320 | Not yet recruiting | Sponsor: Ocuphire Pharma, Inc.

New P3 trial • Ophthalmology

"$OCUP Ocuphire Pharma Announces Submission of New Drug Application to FDA for Nyxol® Eye Drops for Reversal of Mydriasis https://t.co/1piGUqJHUA" (@stock_titan)

NDA • Ophthalmology

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances (clinicaltrials.gov) - P3 | N=145 | Completed | Sponsor: Ocuphire Pharma, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2022 ➔ May 2022

Trial completion • Trial primary completion date • Ophthalmology • Retinal Disorders

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances (clinicaltrials.gov) - P3 | N=160 | Active, not recruiting | Sponsor: Ocuphire Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Retinal Disorders

MIRA-4: Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (clinicaltrials.gov) - P3 | N=23 | Completed | Sponsor: Ocuphire Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Pediatrics

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) (clinicaltrials.gov) - P3 | N=368 | Completed | Sponsor: Ocuphire Pharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3) (clinicaltrials.gov) - P3 | N=368 | Active, not recruiting | Sponsor: Ocuphire Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology

MIRA-4: Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (clinicaltrials.gov) - P3 | N=23 | Active, not recruiting | Sponsor: Ocuphire Pharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Pediatrics

MIRA-4: Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (clinicaltrials.gov) - P3 | N=20 | Recruiting | Sponsor: Ocuphire Pharma, Inc.

New P3 trial • Ophthalmology • Pediatrics

Virtual Investor R&D Day hosted by Ocuphire (GlobeNewswire) - "Virtual Investor R&D Day for the investment community at which six ophthalmic Key Opinion Leaders (KOLs) from retina, optometry and refractive surgery practices will share their thoughts on three large unmet indications, RM, presbyopia, and DR/DME, addressed by Ocuphire's two late-stage clinical drug assets and provide status updates on the development programs for Nyxol and APX3330."

Live event