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PL9643 Ophthalmic Solution
PL9643 is a selective phosphodiesterase 4 (PDE4) inhibitor that reduces inflammatory mediator production in ocular tissues.
PL9643 is a selective phosphodiesterase 4 (PDE4) inhibitor that reduces inflammatory mediator production in ocular tissues. Used for Dry eye disease, Ocular surface inflammation.
At a glance
| Generic name | PL9643 Ophthalmic Solution |
|---|---|
| Also known as | Active study medication |
| Sponsor | ORA, Inc. |
| Drug class | Phosphodiesterase 4 (PDE4) inhibitor |
| Target | PDE4 |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
PDE4 inhibition increases intracellular cAMP levels in immune and inflammatory cells, suppressing the release of pro-inflammatory cytokines and chemokines. This mechanism reduces ocular surface inflammation and is being developed for dry eye disease and other inflammatory ocular conditions.
Approved indications
- Dry eye disease
- Ocular surface inflammation
Common side effects
- Ocular irritation
- Taste perversion
- Headache
Key clinical trials
- A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye (PHASE3)
- Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye (PHASE2)
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 |
|---|---|
| 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:
- PL9643 Ophthalmic Solution CI brief — competitive landscape report
- PL9643 Ophthalmic Solution updates RSS · CI watch RSS
- ORA, Inc. portfolio CI