This section highlights FDA-related milestones and regulatory updates for drugs developed by Opus Genetics (IRD).
Over the past two years, Opus Genetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYNX-3 and OPGx-BEST1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LYNX-3 FDA Regulatory Events
LYNX-3 is a drug developed by Opus Genetics for the following indication: Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYNX-3
- Announced Date:
- September 4, 2025
- Indication:
- Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions
Announcement
Opus Genetics, Inc announced that the first patient has been dosed in LYNX-3, the Company's pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.
AI Summary
Opus Genetics announced dosing of the first patient in LYNX-3, a pivotal Phase 3 clinical trial testing Phentolamine Ophthalmic Solution 0.75% for chronic night driving impairment in patients who have undergone keratorefractive surgery and have reduced mesopic vision.
LYNX-3 is a multicenter, randomized, double-masked, placebo-controlled study enrolling about 200 adults with documented low-light vision issues such as glare, halos, and starbursts after LASIK, PRK, SMILE or RK.
Participants will receive once-daily evening eye drops of Phentolamine 0.75% or placebo for two weeks. The trial’s main goal is to measure the percentage of patients who gain at least three lines of improvement in low-contrast vision under dim light after 15 days.
Secondary measures include patient reports of driving difficulty and night-vision disturbances, as well as overall binocular visual function and safety assessments.
In low-light conditions, Phentolamine works by reducing pupil size to block aberrant peripheral light rays while preserving retinal contrast sensitivity.
Read Announcement
OPGx-BEST1 FDA Regulatory Events
OPGx-BEST1 is a drug developed by Opus Genetics for the following indication: For the treatment of bestrophin-1 (BEST1)-related IRD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OPGx-BEST1
- Announced Date:
- August 18, 2025
- Indication:
- For the treatment of bestrophin-1 (BEST1)-related IRD.
Announcement
Opus Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1 (BEST1)-related IRD.
AI Summary
Opus Genetics IRD, a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application for OPGx-BEST1. This gene therapy is designed to treat bestrophin-1 (BEST1)-related inherited retinal disease, also known as Best disease or vitelliform macular dystrophy. Mutations in the BEST1 gene cause progressive vision loss and can lead to blindness.
With IND clearance, Opus Genetics plans to start a Phase 1/2 trial in the second half of 2025. The multi-center, open-label study will assess the safety, tolerability, and early signs of effectiveness after a single subretinal injection of OPGx-BEST1. Researchers will measure changes in visual function and retinal structure to explore the therapy’s biological activity.
OPGx-BEST1 uses Opus Genetics’ proprietary AAV-based platform to deliver a working copy of the BEST1 gene directly into retinal pigment epithelium cells. Preclinical studies showed restored BEST1 protein expression and improved retinal function in disease models, supporting the move into human trials.
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