PMP2207 (Blepharitis) – Phase 3
A novel ocular ointment formulation of pimecrolimus, an established anti-inflammatory medicine. The active agent has a well-characterized safety profile and is free from corticosteroid side effects.
PMP2207 has completed Phase 2. The results of the 12-week, randomized, double-blind study, generated clear evidence of a clinically meaningful treatment effect. Compared to patients receiving the ointment vehicle, those treated with PMP2207 experienced a greater improvement in both the signs and symptoms of blepharitis, which was evident after only 2 weeks and was sustained throughout the 12 weeks of treatment.
Based on these findings, the Phase 3 programme is designed to deliver the following product profile:
PMP2207 Target Product Profile - Blepharitis
Based on Phase 2 clinical results
Mechanism of Action
- A selective inhibitor of pro-inflammatory mediators
- The first systematically studied and approved drug treatment
Presentation & Dosing
- Prescription only product
- Ophthalmic ointment applied to the eyelid and eyelid margin twice daily
Efficacy
- Provides relief of signs and symptoms of blepharitis within 2 weeks
- Reduced redness and swelling of the eyelid margin
- Reduction in ocular debris
- Reduced ocular discomfort
- Maintains control of signs and symptoms for 3 months
Safety
- Avoids safety issues associated with prolonged use of topical corticosteroids
- Avoids potential for precipitating bacterial resistance associated with prolonged use of antibiotics
- Well documented safety profile of active pharmaceutical ingredient