Omeros Corporation, a clinical-stage biopharmaceutical company, has announced positive data from the second of its two pivotal phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.
In this second phase 3 clinical trial comparing OMS302 to placebo, OMS302 met its co-primary endpoints by demonstrating statistically significant (p<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (p=0.0002) reduction of pain in the early postoperative period. OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.
Now with positive data from both trials in the OMS302 phase 3 clinical programme, Omeros plans to submit a New Drug Application (NDA) with the US Food and Drug Administration in the first half of 2013 and a Marketing Authorization Application (MAA) with the European Medicines Agency in mid-2013, potentially allowing sales in 2014.
This multicenter, double-blind, phase 3 clinical trial enrolled 416 patients randomized 1:1 to receive either OMS302 or placebo. The co-primary endpoints were maintenance of intraoperative mydriasis (pupil dilation) and reduction of pain in the early postoperative period. Mydriasis is critical to the safety and surgical ease of lens replacement surgery as intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time. OMS302 also achieved statistical significance in other clinically relevant measures. The results from this trial are consistent with those from Omeros' first OMS302 phase 3 and earlier phase 2b clinical trials.
In this study, as with the earlier clinical trials, OMS302 was well tolerated. The final review of all safety data will occur following the last safety assessment in January 2013. To date, no safety concerns have been identified. Results from this study are expected to be presented at an upcoming major ophthalmology meeting. Omeros also plans to publish the results in a leading peer-reviewed ophthalmology journal.
"The data from this second phase 3 trial are as compelling as those from the first phase 3 and earlier phase 2b trials," stated Alan S. Crandall, director of glaucoma and cataract, senior vice chairman of ophthalmology and visual sciences at the Moran Eye Center, University of Utah, and past president of the American Society of Cataract and Refractive Surgery. "Collectively, these data consistently and convincingly demonstrate that OMS302 addresses two universal needs in lens replacement surgery – maintenance of intraoperative mydriasis and management of postoperative pain. I expect that OMS302 will represent a significant and widely used advance in the practice of ophthalmologic surgeons who perform intraocular lens replacement, improving both surgical ease and patient outcomes."
"As a clinical investigator in both OMS302 phase 3 trials, I was impressed by the substantial benefits observed in a large cohort of my patients who participated in the studies," stated Steven H. Dunn, Fellow of the American Academy of Ophthalmology, Houston Eye Associates. "A good number of patients generally had better postoperative courses and greater overall satisfaction with the entire surgical experience – both critically important to ophthalmologic surgeons and their practices. The maintenance of pupil diameter throughout the lens replacement surgery facilitates the technical aspects of the procedure and, I believe, could reduce the potential for surgical and postoperative complications."
"This successful trial marks another major milestone for Omeros, our employees and our shareholders," said Gregory A. Demopulos, chairman and chief executive officer of Omeros. "We are on track to submit an NDA in the first half of 2013 and an MAA shortly thereafter, and we are continuing to build out our commercialization plan in anticipation of a 2014 market launch. With the anticipated arrival later this year of phase 3 results from our OMS103HP meniscectomy trial as well as phase 1 data from our PDE10 program, together with additional programmes advancing into the clinic in 2013, we expect that OMS302 will be the first of many Omeros products to improve the lives of patients."
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR) surgery, including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent. FDA-approved drugs containing each of these agents have been used in ophthalmological clinical practice for more than 15 years, and both are contained in generic, FDA-approved drugs.
ILR surgery involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR surgery and delivered intracamerally to maintain intraoperative mydriasis (pupil dilation), to prevent surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.