Introduction to OMIDRIA
OMIDRIA, developed by Omeros Corporation, is a unique pharmaceutical product designed for intraocular use during cataract surgery and other intraocular lens replacement (ILR) procedures. It is a combination of phenylephrine and ketorolac injection, formulated to prevent intraoperative miosis (pupil constriction) and reduce postoperative pain.
Clinical Trials Overview
The FDA approval of OMIDRIA was based on the results of two pivotal phase III clinical trials conducted under the OMS302 program.
First Phase III Clinical Trial
This trial, conducted between September 2011 and March 2012, was a randomized, double-blind, placebo-controlled study that enrolled 405 patients across nine locations in the US. The primary outcome measure was intraoperative pupil diameter, while secondary measures included pain during the early postoperative period, postoperative best-corrected visual acuity, and postoperative inflammation as measured by the Summed Ocular Inflammation Score (SOIS)[3].
Second Phase III Clinical Trial
The second trial, conducted between April 2012 and January 2013, was also a randomized, double-masked, placebo-controlled study. It enrolled 416 patients across several study centers in the US and the Netherlands. This trial evaluated the pharmacokinetics of OMIDRIA and measured outcomes such as intraoperative pupil diameter, pain during the early and late postoperative periods, and safety as measured by adverse events[3].
Key Findings
Both trials demonstrated that patients administered with OMIDRIA showed statistically significant and clinically meaningful improvements in preventing miosis and reducing postoperative pain compared to the placebo group. The ocular adverse reactions in the OMIDRIA group were similar to those in the placebo group, including eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation[3][4].
Pediatric Clinical Trial Update
Omeros Corporation recently announced the successful completion of a pediatric clinical trial for OMIDRIA. This completion makes OMIDRIA eligible for an additional six months of marketing exclusivity. The trial involved patients and their families, as well as investigators and clinical site personnel, and marks a significant milestone in the drug's development and regulatory status[1].
Market Analysis
Current Market Position
OMIDRIA has become an integral part of cataract surgery, de-risking the procedure for surgeons and improving patient outcomes. It is the only approved drug for intraocular use to prevent intraoperative miosis and reduce postoperative pain in cataract surgery and ILR procedures[3].
Sale to Rayner Surgical Group
In a significant market development, Omeros Corporation entered into a definitive agreement to sell the OMIDRIA franchise to Rayner Surgical Group. This transaction, valued in excess of $1 billion, includes an upfront payment of $125 million, an additional $200 million in commercial milestone payments, and royalties on both US and ex-US net sales of OMIDRIA. Rayner will pay Omeros 50% of US net sales until the earlier of January 1, 2025, or the payment of the $200-million commercial milestone, after which the royalty rate will adjust to 30%. Outside the US, Omeros will receive a 15% royalty rate on OMIDRIA net sales throughout the applicable patent life on a country-by-country basis[2][5].
Expansion and Growth
Rayner plans to expand the sales force in both the US and internationally, strengthening its commercial presence and accelerating the growth of OMIDRIA sales. This move is expected to enhance the product's market penetration and revenue, particularly as Rayner integrates OMIDRIA into its ophthalmology franchise, which includes intraocular lenses, ophthalmic viscoelastic devices, and dry eye treatments[2][5].
Market Projections
Revenue Potential
The sale of the OMIDRIA franchise to Rayner is expected to generate significant revenue for Omeros through royalties. With a 50% royalty rate on US net sales until the earlier of January 1, 2025, or the payment of the $200-million commercial milestone, and a subsequent 30% rate thereafter, Omeros is poised to benefit from the continued growth and expansion of OMIDRIA sales. The 15% royalty rate on ex-US net sales further adds to the revenue potential[2][5].
Market Expansion
Rayner's plans to expand the sales force and strengthen its commercial presence globally are likely to increase OMIDRIA's market share. The product's integration into Rayner's ophthalmology portfolio, which includes a range of innovative products such as the FDA-approved RayOne EMV intraocular lens, is expected to drive growth and enhance market penetration[2].
Competitive Advantage
OMIDRIA's unique formulation and FDA approval give it a competitive edge in the ophthalmic market. As the only approved drug for preventing intraoperative miosis and reducing postoperative pain, OMIDRIA is well-positioned to continue dominating its niche in cataract surgery and ILR procedures[3].
Safety and Adverse Reactions
Clinical Trial Data
The clinical trials demonstrated that OMIDRIA had ocular adverse reaction rates similar to those of the placebo group. Common adverse reactions included eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Systemic exposure to phenylephrine may cause elevations in blood pressure, but overall, the safety profile of OMIDRIA has been favorable[1][4].
Conclusion
OMIDRIA has established itself as a critical component in cataract surgery and ILR procedures, offering significant benefits in preventing intraoperative miosis and reducing postoperative pain. The successful completion of the pediatric clinical trial and the sale of the franchise to Rayner Surgical Group position OMIDRIA for continued growth and market dominance.
Key Takeaways
- Clinical Trials: OMIDRIA was approved based on two pivotal phase III clinical trials showing significant improvements in preventing miosis and reducing postoperative pain.
- Pediatric Trial: Completion of the pediatric trial earns OMIDRIA an additional six months of marketing exclusivity.
- Market Sale: The sale to Rayner Surgical Group is valued over $1 billion, with significant royalties for Omeros.
- Market Expansion: Rayner plans to expand the sales force and strengthen its commercial presence globally.
- Safety Profile: OMIDRIA has a favorable safety profile with adverse reactions similar to those of the placebo group.
FAQs
Q: What is OMIDRIA used for?
A: OMIDRIA is used during cataract surgery and other intraocular lens replacement procedures to prevent intraoperative miosis and reduce postoperative pain.
Q: Who developed OMIDRIA?
A: OMIDRIA was developed by Omeros Corporation.
Q: What are the common adverse reactions associated with OMIDRIA?
A: Common adverse reactions include eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.
Q: What is the current market status of OMIDRIA?
A: OMIDRIA has been sold to Rayner Surgical Group, which plans to expand its sales force and commercial presence globally.
Q: What are the royalty rates Omeros will receive from Rayner?
A: Omeros will receive 50% of US net sales until the earlier of January 1, 2025, or the payment of the $200-million commercial milestone, after which the rate will adjust to 30%. Outside the US, Omeros will receive a 15% royalty rate on OMIDRIA net sales.
Sources
- Omeros Corporation Announces Completion of Patient Enrollment in Pediatric Trial of OMIDRIA®. Investor.Omeros.com.
- Omeros to Sell Omidria Franchise to Rayner in a Deal Worth More Than $1 Billion. Eyewire.News.
- Omidria™ for Use in Cataract and Other Intraocular Lens Replacement (ILR) Procedures. ClinicalTrialsArena.com.
- Safety | OMIDRIA® (phenylephrine and ketorolac). Omidria.com.
- Omeros Announces Agreement to Sell OMIDRIA® Franchise to Rayner Surgical in a Transaction Valued in Excess of $1 Billion. Investor.Omeros.com.
