PMP2207 (Blepharitis) – Phase III

Premark’s lead development asset is a novel ocular formulation of 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 II. 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 III programme is designed to deliver the following product profile:

PMP2207 Target Product Profile - Blepharitis

Based on Phase II 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