Ocuphire Pharma, Inc. engages in the research and development of ophthalmic biopharmaceutical products. It focuses on developing and commercializing therapies for the treatment of several eye disorders. The company was founded by Mina Patel Soouch and Alan R. Meyer in February 2018 and is headquartered in Farmington Hills, MI.
Clinical Trials
49
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
3
6.1%
Completed
33
67.3%
Not yet recruiting
1
2.0%
Recruiting
5
10.2%
Terminated
1
2.0%
Unknown
4
8.2%
Withdrawn
2
4.1%
No approval data available
- Peer-reviewed LYNX-1 results show 21% of patients on 0.75% phentolamine drops gained at least three lines on a dim-light eye chart by day 15 versus 3% on placebo. - The once-nightly drop produces moderate pupil constriction lasting at least 20 hours by blocking iris dilator muscle receptors without engaging the ciliary muscle. - The FDA has granted Fast Track designation for night driving impairment, while confirmatory LYNX-3 topline results are expected in the first half of 2026. - Investigators caution the trial measured eye chart scores and symptoms, not real-world driving performance or crash risk, and the drug remains unapproved for night vision.
- All five participants in the low-dose Cohort 1 of the Phase 1/2 BIRD-1 trial showed clinically meaningful visual function improvement, with structural improvements in four of five. - OPGx-BEST1 showed no serious adverse events, dose-limiting toxicities or intraocular inflammation, with all treatment-related adverse events mild or moderate. - The FDA aligned on at least 3 decibels of microperimetry improvement in at least five prespecified loci plus a patient-reported outcome as a potential pivotal endpoint. - Higher-dose Cohort 2 was over-enrolled to eight participants, with dosing expected to complete in Q4 2026 and topline three-month data in Q2 2027.
- The FDA has accepted Viatris' supplemental New Drug Application for MR-141 (phentolamine ophthalmic solution 0.75%) to treat presbyopia, with a PDUFA goal date of October 17, 2026. - The application is supported by positive Phase 3 data from VEGA-2 and VEGA-3 trials, which met all primary and key secondary endpoints with no treatment-related serious adverse events. - Presbyopia affects approximately 90% of adults in the U.S. over age 45, representing nearly 128 million people who experience age-related loss of near vision focusing ability. - Phentolamine offers a physiological approach that relaxes the iris dilator muscle to improve near vision while preserving distance vision, unlike current treatments that engage the ciliary muscle.
- Opus Genetics has launched a clinical trial for OPGx-MERTK, an AAV-based gene therapy targeting MERTK-related retinitis pigmentosa, a rare inherited eye disease affecting approximately 60,000 patients worldwide. - The trial will be conducted at Cleveland Clinic Abu Dhabi starting in 2026, funded through Abu Dhabi's Healthcare Research and Innovation Fund, marking the first MERTK gene therapy clinical trial in the UAE. - The investigational therapy delivers a functional copy of the MERTK gene to retinal cells, addressing mutations that impair the retina's ability to recycle photoreceptor components and lead to progressive vision loss. - Currently, there are no approved treatments for MERTK-related retinitis pigmentosa, making this trial the first potential therapeutic opportunity for patients facing inevitable blindness from this condition.
- Opus Genetics' investigational gene therapy OPGx-LCA5 is helping individuals born blind regain partial sight in an ongoing Phase 1/2 clinical trial. - The therapy targets mutations in the LCA5 gene by delivering a functional copy directly to retinal cells to restore photoreceptor function. - Patient Lindsey Rambo, the second participant in the trial, shared her experience on Good Morning America, highlighting the life-changing potential of the treatment. - The company is advancing multiple gene therapy programs for inherited retinal diseases, including trials for both LCA5 and BEST1 mutations.
- Opus Genetics received FDA clearance for its IND application for OPGx-BEST1, a gene therapy targeting BEST1-related inherited retinal disease. - The company plans to initiate a Phase 1/2 multi-center, open-label trial in the second half of 2025 to evaluate safety and preliminary efficacy. - BEST1-related IRDs currently have no approved treatments, representing a significant unmet medical need for patients facing progressive vision loss. - The therapy uses AAV-based gene delivery to provide functional BEST1 gene copies directly to retinal pigment epithelium cells.
- Viatris announced positive top-line results from the Phase 3 LYNX-2 trial of MR-142, achieving its primary endpoint of ≥15-letter gain in mesopic low contrast distance visual acuity compared to placebo. - The study demonstrated patient-reported functional benefits in treating chronic night driving impairment in keratorefractive patients, addressing a condition with no current FDA-approved therapies. - MR-142 showed no evidence of tachyphylaxis over the 6-week study period and maintained a consistent safety profile with previous trials. - The FDA has granted Fast Track designation to MR-142, potentially accelerating development and review for this unmet medical need affecting millions of patients worldwide.
- Opus Genetics receives FDA Fast Track designation for Phentolamine Ophthalmic Solution 0.75% to treat night driving impairment in post-keratorefractive surgery patients. - The company completes enrollment in VEGA-3 Phase 3 trial evaluating the same solution for presbyopia, with 545 participants across 39 U.S. sites. - LYNX-2 Phase 3 trial for post-surgical night vision impairment is 95% enrolled, with completion expected in first half of 2025.
- Opus Genetics has dosed the first pediatric patient in their Phase 1/2 trial of OPGx-LCA5 gene therapy for Leber congenital amaurosis, with initial data expected by Q3 2025. - New 12-month data from the first three adult patients treated with OPGx-LCA5 confirms durability of positive responses observed at 6 months, with results to be presented at a medical conference in Q2 2025. - The company has scheduled an FDA meeting in March 2025 to discuss Phase 3 trial design and registrational endpoints, marking a significant step toward potential therapeutic advancement.
- Opus Genetics has reached an agreement with the FDA under a Special Protocol Assessment (SPA) for a Phase 3 trial of oral APX3330. - The Phase 3 trial will assess APX3330's efficacy in treating moderate to severe non-proliferative diabetic retinopathy (NPDR). - The primary endpoint is a reduction in 3-step or greater worsening on the binocular diabetic retinopathy severity scale (DRSS) score. - APX3330, a first-in-class Ref-1 inhibitor, aims to slow DR progression, with Opus seeking a partner to fund further development.
