Omidria (phenylephrine/ketorolac) / Omeros - LARVOL DELTA

Optimizing pain management and pupil dilation in cataract surgery: a systematic review and meta-analysis of phenylephrine/ketorolac (OMIDRIA®). (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Phenylephrine/ketorolac (OMIDRIA®) demonstrates superior efficacy in maintaining intraoperative mydriasis, reducing postoperative pain, and minimizing opioid use without increasing adverse events. This combination offers a preferable alternative to traditional agents, potentially setting a new standard for pain management and pupil dilation in cataract surgery."

Clinical • Journal • Retrospective data • Cataract • Inflammation • Ophthalmology • Pain

Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma. (PubMed, Future Sci OA) - "Intracameral phenylephrine 1.0%/ketorolac 0.3% (OMIDRIA®) is used during cataract surgery to prevent intraoperative miosis and reduce postoperative pain...The method met the acceptance criteria with respect to selectivity, specificity, precision, accuracy, linearity, dilution integrity, and stability. The validated method can use plasma as a surrogate matrix for quantitation of ketorolac in aqueous and vitreous humor, thereby eliminating the need to procure human vitreous and aqueous samples for validation prior to initiation of a clinical trial."

Journal • Cataract • Ophthalmology • Pain

EPICAT: Effectiveness of Periocular Drug Injection in CATaract Surgery (clinicaltrials.gov) - P3 | N=628 | Terminated | Sponsor: Luigi Rondas | Trial completion date: Apr 2024 ➔ Aug 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Aug 2024; Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.

Surgery • Trial completion date • Trial primary completion date • Trial termination • Cataract • Macular Edema • Ophthalmology • Retinal Disorders

Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC. (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Inder Paul Singh, M.D.

New P1/2 trial • Surgery • Cataract • Ophthalmology

Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3% (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: DHS Consulting

New P1 trial • Surgery • Cataract • Conjunctivitis • Ophthalmology

Dropless Cataract Surgery: The Effect of Intracameral Phenylephrine/Ketorolac Infusion as a Single Agent on Postoperative Outcomes. (PubMed, Cureus) - "However, a 13.8% AE rate is comparable to the rates of postoperative CME, corneal edema, pain, and irritation in the published literature. Thus, more research is needed to truly define this approach as inferior or non-inferior to the current standard of care."

Journal • Surgery • Cataract • Inflammation • Macular Edema • Ophthalmology • Pain

Omeros Corporation Reports First Quarter 2024 Financial Results (Businesswire) - "Our Phase 1 multiple-ascending-dose study of OMS1029 is expected to read out data later this quarter....Several large market indications are being evaluated for Phase 2 clinical development of OMS1029 and we expect to select an indication in the third quarter of 2024. The indications under consideration include neovascular age-related macular degeneration, sometimes referred to as 'wet AMD.'...'Through the sale of a portion of our OMIDRIA royalties in February, we have extended our cash runway into 2026....Omeros continues to retain any and all royalties on ex-U.S. OMIDRIA sales and, from and after January 1, 2032, all royalties globally....For the first quarter of 2024, we earned OMIDRIA royalties of $9.4 million on Rayner’s U.S. net sales of $31.2 million. This compares to earned OMIDRIA royalties of $9.2 million during the first quarter of 2023 on U.S. net sales of $30.7 million.'"

Commercial • New P2 trial • P1 data • Pain • Rare Diseases • Wet Age-related Macular Degeneration

Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery (clinicaltrials.gov) - P4 | N=15 | Completed | Sponsor: Silverstein Eye Centers | Unknown status ➔ Completed | N=75 ➔ 15

Enrollment change • Surgery • Trial completion • Cataract • Inflammation • Ophthalmology • Pain

Retrospective Study of Cataract Surgery Complication Rates at a VA Center: Comparing Omidria Vs. Standard of Care (ASCRS-ASOA 2023) - "Purpose To compare cataract surgery complications at a VA Center after intracameral phenylephrine 1%/ketorolac 0.3% or epinephrine/lidocaine.Hundreds of ophthalmology residents train nationwide in the VA system annually & dozens at our center.Assessing resident surgeries may offer insight the impact of intraoperative medications on surgical outcomes.MethodsWe conducted a retrospective chart review of cataract surgeries (January 2016 through June 2022), comparing patients who received intracameral phenylephrine/ketorolac to those who received phenylephrine/lidocaine.All patients received the same pre- and post-operative care.Patients with previous eye trauma or eye surgery were excluded.The primary endpoint is the rate of complications, including those related to poor pupil dilation and IFIS.Secondary endpoints include mean surgical time, PED use, and post-operative inflammation.Data will also be stratified by resident vs attending surgeon, cataract density, use of..."

Retrospective data • Surgery • Cataract • Inflammation • Ophthalmology

Complication Rates in Cataract Surgery Patients Receiving Omidria & Steroids Intraoperatively Vs Postoperative Topical NSAID and Steroid (ASCRS-ASOA 2023) - "Purpose To compare the rates of inflammation, complications including CME, need for rescue therapy, and pain and discomfort in cataract surgery patients receiving either topical post-operative therapy with NSAID, steroid, and antibiotic drops or intraoperative NSAID, antibiotic, and steroid with no topical medications.MethodsPatients undergoing bilateral cataract surgery will have one eye randomized to the control group to receive post-operative topical NSAIDs, steroids, and antibiotics, and the intervention eye randomized to receive Omidria, intracameral moxifloxacin, and either Dextenza or subconjunctival triamcinolone.All eyes will have a 3-day pre-operative course of a topical NSAID and will be followed for 3 months following surgery.The primary endpoint is postoperative inflammation at 1 day, 1 week, 1 month, and 3 months.Secondary endpoints include complication rates, rate of CME, need for rescue therapy, and patient pain.ResultsWe hypothesize that intervention..."

Clinical • Surgery • Cataract • Inflammation • Ophthalmology • Pain

Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: University of Florida | N=70 ➔ 0 | Trial completion date: Aug 2022 ➔ Aug 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Aug 2022 ➔ Aug 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Cataract • Pain

"$OMER Omeros Completes Sale of OMIDRIA® Franchise to Rayner Surgical https://t.co/Gn9PTvLyyD" (@stock_titan)

EPICAT: Effectiveness of Periocular Drug Injection in CATaract Surgery (clinicaltrials.gov) - P3; N=808; Recruiting; Sponsor: Luigi Rondas

New P3 trial • Cataract • Macular Edema • Ophthalmology • Retinal Disorders

No Drop Post-Op Cataract Surgery (clinicaltrials.gov) - P4; N=100; Completed; Sponsor: Wake Forest University Health Sciences; Recruiting ➔ Completed; N=200 ➔ 100

Enrollment change • Trial completion • Cataract • Macular Edema • Ophthalmology

Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain (clinicaltrials.gov) - P4; N=70; Not yet recruiting; Sponsor: University of Florida; Trial completion date: May 2022 ➔ Aug 2022; Initiation date: May 2021 ➔ Aug 2021; Trial primary completion date: May 2022 ➔ Aug 2022

Trial completion date • Trial initiation date • Trial primary completion date • Cataract • Pain

Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain (clinicaltrials.gov) - P4; N=70; Not yet recruiting; Sponsor: University of Florida

New P4 trial • Cataract • Pain

Prevention of macular edema after cataract surgery Het voorkomen van netvlieszwelling (maculaoedeem) na een staaroperatie (clinicaltrialsregister.eu) - P3; N=808; Ongoing; Sponsor: Academic Hospital Maastricht (azM)

New P3 trial • Cataract • Macular Edema • Ocular Infections • Ophthalmology

"$OMER CMS Confirms Continued Separate Payment for Omeros’ FDA-Approved OMIDRIA® in Ambulatory Surgery Centers https://t.co/eigcWj4eDb" (@stock_titan)

FDA event

Surgeon shares pearls for new drug delivery options (Healio) - "In a Healio Video Perspective from the virtual OSN New York meeting, Lisa Nijm, MD, JD, discusses the importance of new drug delivery options over the use of drops in the COVID-19 era. She discusses pearls for using Dexycu (EyePoint), Dextenza (Ocular Therapeutix) and Omidria (Omeros) in cataract surgery."

Video

Omeros seeks new payment status for Omidria after pass-through expires (Healio) - "''CMS' policy for separate payment applies to non-opioid pain management surgical drugs that are used in the ASC setting and that are policy-packaged under CMS' Outpatient Prospective Payment System,' the release said. In previous annual rules, CMS considered Omidria to be 'a non-opioid pain management drug used in the ASC setting that is policy packaged as a drug that functions as a supply in a surgical procedure.'"

Online posting

Real-world opioid prescribing after cataract surgery among patients who received intracameral phenylephrine and ketorolac 1.0%/0.3. (PubMed, Curr Med Res Opin) - "Patients without recent opioid use who received P/K during cataract surgery, despite greater incidence of preoperative comorbidities and higher risk for surgical complexity, were prescribed fewer opioid pills following surgery than patients who did not receive P/K."

Clinical • Journal • Real-World Evidence • Cataract • Ophthalmology

Studies Evaluate Effectiveness of Intracameral Omidria for Reducing Postoperative CME (Eyewire News) - "Denise M. Visco...recently co-authored a retrospective study that examined 2,218 eyes (n=1402) to assess the effectiveness of Omidria during cataract surgery compared with postoperative topical steroids in reducing incidence...'At a certain point in time, my practice converted from a combined topical steroid/nonsteroidal regimen to intracameral nonsteroidal and topical nonsteroidal only. The goal of the study was to see if I was delivering the same quality of care for patients after the change,' Dr. Visco said....'There's a lot of good science out there showing that Omidria alone reduces COX-1 and COX-2 enzymatic reaction after cataract surgery, at least up to 10 hours,' Dr. Walter said."

Media quote

No Drop Post-Op Cataract Surgery (clinicaltrials.gov) - P4; N=200; Recruiting; Sponsor: Wake Forest University Health Sciences; Active, not recruiting ➔ Recruiting

Enrollment open • Cataract • Macular Edema • Ophthalmology

Continuous intracameral phenylephrine-ketorolac irrigation for miosis prevention in femtosecond laser-assisted cataract surgery: Reduction in surgical time and iris manipulation. (PubMed, J Cataract Refract Surg) - "These data support the hypotheses that using phenylephrine and ketorolac reduces FLACS time and the need for pupil expansion devices."

Journal • Cataract • Ophthalmology

Case Studies in Pupil Dilation (Cataract & Refractive Surgery Today) - "Eric D. Donnenfeld, MD: A patient with a history of trauma and floppy eyelid syndrome presented for cataract surgery. Although the patient's pupil was not that small, I decided to place an I-Ring pupil expansion device (Beaver Visitec International) given the patient's history of ocular trauma. I use phenylephrine and ketorolac intraocular solution 1%/0.3% (Omidria, Omeros) for all of my patients whose insurance covers it, but especially if they have a history of ocular trauma, small pupils, intraoperative floppy iris syndrome (IFIS), or pseudoexfoliation. This strategy has dramatically reduced my need for pupil expansion devices."

Online posting