Anti-Inflammatory

Within the indication of lid margin disease, Ora has developed standardized grading scales for blepharitis and meibomitis based on anatomical classifications. These standardized validated photograph control scales have already been utilized in two IND studies.

Our Anti-Inflammatory Team
collaborates with internal clinical-regulatory teams to provide industry-leading support in program strategy
Broad International Experience
including multi-center, international post-operative cataract surgery anti-inflammatory trials
Bring Us Your Novel API
and we'll help you to transform it into a viable ophthalmic therapy
Aron Shapiro

Aron Shapiro
VP, Anti-infective, Glaucoma, AI, Retina

Anti-inflammatory therapies have a wide variety of ophthalmic applications. The anti-inflammatory market has experienced robust growth, with U.S. revenues increasing 39% and U.S. prescriptions increasing 16% from 2007 to 2009 (IMS(2009)).

The majority of broad-acting ophthalmic anti-inflammatories are typically developed for the treatment of post-operative inflammation after cataract surgery. Additional indications include dry eye and inflammatory conditions of the eyelid, such as blepharitis and meibomitis, as well as uveitis, one of the leading causes of blindness. Eye care providers treat a wide range of ocular inflammatory diseases, but they are restricted to relatively few anti-inflammatory therapeutic options.

Within the indication of lid margin disease, Ora has developed standardized grading scales for blepharitis and meibomitis based on anatomical classifications. These standardized validated photograph control scales have already been utilized in two IND studies.

Ora has conducted numerous Phase II – IV anti-inflammatory clinical trials and our research team has extensive experience in comfort, safety, and pharmacokinetic studies, as well as Phase III multi-center pivotal studies.

The potential for novel anti-inflammatory mechanisms of action has attracted a number of innovative companies to develop ophthalmic formulations as they search for the most efficient pathway to transform their novel APIs into viable ophthalmic therapies. These companies look to Ora’s capabilities, which include:

  • Preclinical Proof-of-Concept
  • Clinical/Regulatory Strategy
  • Study Design
  • Site Selection and Qualification
  • Clinical Study and Multi-Center Site Management