Omeros Corporation announced that it is advancing two of its product candidates from its PharmacoSurgery platform - OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery - into phase 3 clinical development programmes. Both of these product candidates are added to standard irrigation solutions and delivered intra-operatively to the operative site throughout the surgical procedure to preemptively block the molecular-signalling and biochemical cascade caused by surgical trauma and to provide clinical benefits both during and after surgery.
"I am pleased to report today that we have already begun advancing phase 3 clinical programmes for OMS103HP and OMS302," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Both of these drugs generated positive efficacy and safety data in large phase 2 clinical trials and, based on our analysis of those data, we are optimistic that each drug's clinical benefits will be further demonstrated in its respective phase 3 clinical programme."
The OMS103HP Phase 3 clinical programme will evaluate the drug's safety and efficacy in improving postoperative joint function and reducing pain following arthroscopic partial meniscectomy surgery. The programme will consist of two randomized, double-blind, vehicle-controlled, multicenter trials to be conducted in North America and Europe. Omeros expects data from the North American trial in the first half of 2012. The Company is in discussions with European regulatory authorities regarding the second clinical trial and, assuming sufficient resources, plans to begin that trial during the fourth quarter of 2011. The primary endpoint for these trials will be performance on the Knee Injury and Osteoarthritis Outcome Score (KOOS), a validated patient-reported outcomes measure used in the successful phase 2 meniscectomy trial.
OMS302 will be evaluated for safety and efficacy in patients undergoing intra-ocular lens replacement surgery. The trials will enrol both cataract surgery and refractive lens exchange patients. This clinical program will involve two randomized, double-blind, placebo-controlled, multicenter trials. The first trial will be conducted in North America and data are expected in the first half of 2012. Omeros will initiate the second trial in Europe following discussions with regulators to ensure that data collected meet European expectations for marketing approval. The co-primary endpoints for these trials - maintenance of intraoperative pupil dilation (mydriasis) and reduction of postoperative pain - are the same as those achieved in the recently completed 221-patient phase 2b trial.
OMS103HP is Omeros' PharmacoSurgery product candidate being developed for use during arthroscopic procedures, including partial meniscectomy surgery, and was designed to provide a multimodal approach to preemptively block the inflammatory cascade induced by arthroscopy. OMS103HP is a proprietary combination of anti-inflammatory/analgesic active pharmaceutical ingredients (APIs), each with well-known safety and pharmacologic profiles. Each of the APIs are components of generic, FDA-approved drugs that have been marketed in the United States as over-the-counter or prescription drug products for over 15 years and have established and well-characterized safety profiles.
In a phase 2 clinical trial that evaluated OMS103HP in patients undergoing partial meniscectomy surgery, OMS103HP provided clinically meaningful and significantly greater efficacy than vehicle as measured by patient-reported functional scores using the Knee Injury and Osteoarthritis Outcome Score (KOOS), passive knee flexion and visual analog scale pain scores. The patient-reported outcomes measuring symptoms, pain, activities of daily living, sport and recreational activities and quality of life associated with the operated knee showed a sustained benefit through postoperative Day 90.
In the first quarter of 2011, Omeros announced that OMS103HP failed to meet pre-specified efficacy endpoints in a Phase 3 clinical program in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Omeros is unable to draw any conclusions about OMS103HP's effect in the phase 3 ACL programme due to confounding factors, and the company has no plans to conduct additional ACL reconstruction trials at this time. The primary endpoint for Omeros' meniscectomy phase 3 trials is different than that used in its ACL program. Accordingly, Omeros believes that the results of its ACL programme do not affect the viability of its meniscectomy programme.
OMS302 is Omeros' PharmacoSurgery product candidate being developed for use during ophthalmological procedures including cataract and other lens replacement surgery. OMS302 is a proprietary combination of an anti-inflammatory API and an API that causes mydriasis (pupil dilation), each with well-known safety and pharmacologic profiles. FDA-approved drugs containing each of these APIs have been used in ophthalmological clinical practice for more than 15 years, and both APIs are contained in generic, FDA-approved drugs.
In a phase 2b clinical trial that evaluated OMS302 in patients undergoing cataract surgery, OMS302 demonstrated clinically meaningful and statistically significant benefits in both prespecified co-primary endpoints - maintenance of intraoperative mydriasis and reduction of pain in the early postoperative period. OMS302 also reduced the frequency of complaints of moderate and severe pain.
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, coagulopathies and disorders of the central nervous system.