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APRACLONIDINE HYDROCHLORIDE
Apraclonidine Hydrochloride is a marketed drug primarily indicated for the prevention of post-surgical intraocular pressure (IOP) elevation. Its key strength lies in its established market presence and the protection offered by a key composition patent expiring in 2028. The primary risk is the eventual patent expiry, which could lead to increased competition from generics.
At a glance
| Generic name | APRACLONIDINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1987 |
Approved indications
- Post-surgical IOP elevation prevention
Common side effects
- Conjunctival blanching
- Upper lid elevation
- Mydriasis
- Burning
- Discomfort
- Foreign body sensation
- Dryness
- Itching
- Blurred or dimmed vision
- Allergic response
- Conjunctival microhemorrhage
- Abdominal pain
Serious adverse events
- Bradycardia
- Vasovagal attack
- Palpitations
- Orthostatic episode
- Ocular injection
- Irregular heart rate
- Ocular inflammation
- Hypotony
- Shortness of breath
- Hypersensitivity
Key clinical trials
- A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness (PHASE3)
- Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis (PHASE4)
- Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis (PHASE2)
- Randomized Prospective Study of Selective Laser Trabeculoplasty (SLT) Versus Argon Trabeculoplasty (ALT) in Patients With Pseudoexfoliation Glaucoma and Ocular Hypertension (PHASE3)
- Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- APRACLONIDINE HYDROCHLORIDE CI brief — competitive landscape report
- APRACLONIDINE HYDROCHLORIDE updates RSS · CI watch RSS