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Opgx-Rdh12
Lca5, Leber Congenital Amaurosis, Leber Congenital Amaurosis (Lca)
Phase I/II
Not Yet Recruiting
Phase 1b/2a Dose Exploration Study to Determine Safety and Tolerability of Subretinal OPGx-RDH12-1001 for LCA5-Associated Inherited Retinal Degeneration (LCA5-IRD)
Jun 24, 2026
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Phentolamine Opthalmic Solution 0.75%, Low Dose Pilocarpine, Low Dose Pilocarpine Vehicle
Presbyopia
Phase III
Completed
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia
Dec 02, 2022
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Phentolamine Ophthalmic Solution 0.75%, Pilocarpine
Presbyopia
Phase II
Completed
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Dec 15, 2020
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Phentolamine Ophthalmic Solution 0.75%
Dim Light Vision Disturbances
Phase III
Completed
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
Nov 16, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Opus Genetics (IRD) have in its pipeline
IRD is currently developing the following drugs: Opgx-Rdh12, 0.75% Phentolamine Ophthalmic Solution, Opgx-Best1. These drug candidates are in various stages of clinical development as the company works toward FDA approval.