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Topic: OMIDRIA

CMS (US Medicare) awarded Omidria "Separate Payment" instead of bundling it as a "surgical supply" in the ASC setting.
CMS wrote:https://charts.stocktwits.com/production/original_260997662.png

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

CMS Confirms Continued Separate Payment for Omeros’ FDA-Approved OMIDRIA ® in Ambulatory Surgery Centers Separate payment for OMIDRIA retroactively effective as of October 1, 2020 —
December 03, 2020 07:30 AM Eastern Standard Time
SEATTLE--( BUSINESS WIRE )--Omeros Corporation (Nasdaq: OMER) announced today that the Centers for Medicare & Medicaid Services (CMS) confirmed separate payment in ambulatory surgery centers (ASCs) for Omeros’ cataract surgery drug OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system (OPPS) and the ASC payment system for calendar year 2021, CMS confirmed that OMIDRIA qualifies for separate payment under CMS’ policy for non-opioid pain management surgical drugs when used in the ASC setting. This separate payment for OMIDRIA is effective retroactively beginning October 1, 2020.

“Omeros appreciates CMS’ decision to continue paying separately for our ophthalmic drug OMIDRIA,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Having just come off its pass-through status, this is the first time that OMIDRIA qualifies under CMS’ payment policy for non-opioid pain-management surgical drugs in the ASC setting. In addition to reducing patient exposure to opioids, CMS’ decision continues to provide important access to OMIDRIA for Medicare beneficiaries and to allow ophthalmic surgeons to use their best medical judgment to treat those patients. This is a good outcome for surgical facilities, surgeons and their patients.”

OMIDRIA is the first and only FDA-approved product for use during cataract or lens replacement surgery that prevents pupil constriction during surgery and reduces postoperative ocular pain. In post-marketing studies, OMIDRIA has been shown to have a broad range of benefits, including the reduction of sight-threatening complications and mitigating the need for intra- and postoperative steroids. OMIDRIA is approved for use in both adults and children.

About OMIDRIA ®

Omeros’ OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown to (1) prevent intraoperative floppy iris syndrome (IFIS) and iris prolapse, (2) significantly reduce complication rates (including sight-threatening cystoid macular edema and breakthrough iritis), use of pupil-expansion devices, and surgical times, (3) significantly reduce intraoperative use of the opioid fentanyl and postoperative prescription opioids, (4) enable performance of surgery and postoperative care without the use of steroids, and (5) significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the post-launch outcomes cited above are not in its currently approved labeling.

Important Safety Information for OMIDRIA ®

Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a rolling biologics license application under review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3 inhibitor OMS906, which targets the complement system’s alternative pathway, recently entered the clinic, and the company’s PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

AstraZeneca buying Alexion in $39B
Cash + stock deal
Dec. 12, 2020

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

OMEROS TO PRESENT AT THE 39TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE
SEATTLE--(BUSINESS WIRE)--Jan. 11, 2021-- Omeros Corporation (Nasdaq: OMER) today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference this week. This conference is being held as a virtual conference this year. The presentation is scheduled for Wednesday, January 13, 2021 at 10:50 a.m. EST.

The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company’s website at www.omeros.com under “Events.” The archived webcast will be available for 30 days.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

BIOLOGICS LICENSE APPLICATION FOR NARSOPLIMAB IN HSCT-TMA ACCEPTED FOR PRIORITY REVIEW BY U.S. FDA
-- FDA sets PDUFA date of July 17, 2021 --

SEATTLE--(BUSINESS WIRE)--Jan. 19, 2021-- Omeros Corporation (Nasdaq: OMER) announced today that the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the BLA.

FDA grants Priority Review to applications for therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, prevention or diagnosis of serious conditions. Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designations and orphan drug designations from FDA for each of HSCT-TMA and IgA nephropathy.

"The filing of our BLA by FDA marks an important milestone on the path to commercialization of narsoplimab," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "There is no FDA-approved product for the treatment of transplant-associated TMA, a frequently fatal complication of stem cell transplantation. We appreciate FDA’s collaborative approach throughout the development of our breakthrough therapy-designated product narsoplimab, and we are committed to continue working closely with the FDA review team to make the drug available to patients who need it."

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

https://www.forbes.com/sites/stephenbro … asons-why/

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

Treating sequelae will be a huge task, with many patients, even ones who did not have severe CV19, over a long time period.

https://charts.stocktwits.com/production/original_292728494.jpg

{h/t to Stellar Capital for tweets}

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.

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Re: OMIDRIA

OMEROS AND QUANTUM LEAP ANNOUNCE FIRST PATIENTS DOSED WITH NARSOPLIMAB IN THE I-SPY COVID-19 TRIAL
-- Adaptive Platform Trial is Evaluating Drugs and Investigational Products in the Treatment of Critically Ill COVID-19 Patients --

SEATTLE & SAN FRANCISCO--(BUSINESS WIRE)--Mar. 23, 2021-- Omeros Corporation (Nasdaq: OMER) and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in the I-SPY COVID-19 Trial began earlier this month. The I-SPY COVID-19 Trial is an adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative. The goal of the trial is to screen rapidly, in parallel, multiple promising agents in order to identify drugs that will have a high impact on reducing mortality and avoid or reduce the duration of mechanical ventilation for critically ill COVID-19 patients.

“We’re excited that narsoplimab is one of the agents that has entered the I-SPY COVID-19 Trial,” said Laura Esserman, MD, MBA, co-founder of Quantum Leap Healthcare Collaborative, Principal Investigator of the I-SPY trial program, and Professor of Surgery and Radiology at the University of California – San Francisco. “The mechanism of action, specifically targeting endothelial injury, along with its safety profile and initial data generated in critically ill COVID-19 patients make a compelling case for this agent. The pulmonary and critical care investigators leading the I-SPY COVID Trial uniformly endorsed narsoplimab and made it a high-priority candidate for the trial. Together, we will be able to generate data on the ability of the agent to reduce the time to recovery and lower mortality.”

Narsoplimab is Omeros’ lead antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement. It is the only complement inhibitor invited to participate in the I-SPY COVID-19 Trial. Narsoplimab has been administered under compassionate use to treat severely ill COVID-19 patients requiring mechanical ventilation, with impressive outcomes.

“Omeros is pleased to be working with Quantum Leap Healthcare Collaborative in this important effort,” said Gregory Demopulos, MD, Omeros’ chairman and chief executive officer. “With the multiple variants of SARS-CoV-2 already spreading globally, it is clear that vaccines alone likely will not be sufficient. Drs. Esserman, Calfee, and Liu and their team have established an innovative, efficient and rapidly enrolling platform trial to help identify treatments that can be useful in the fight against COVID-19, and we look forward to learning the outcomes of I-SPY study patients treated with narsoplimab.”

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. Its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. Omeros’ MASP-3 inhibitor OMS906, which targets the complement system’s alternative pathway, recently entered the clinic, and the company’s PDE7 inhibitor OMS527 has successfully completed its Phase 1 trial. Omeros’ pipeline holds a diverse group of preclinical programs including a novel antibody-generating technology and a proprietary GPCR platform through which it controls 54 new GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing small-molecule GPR174 inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

About Narsoplimab

Narsoplimab, also known as “OMS721,” is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

About the I-SPY TRIALS

The I-SPY 2 TRIAL for stage II and III breast cancer is the longest running and most successful adaptive platform trial in oncology. Quantum Leap was able to use the existing I-SPY 2 TRIAL infrastructure methodology to develop the I-SPY COVID Trial (Investigation of Serial studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning). The I-SPY COVID Trial is designed to rapidly screen promising experimental treatments, and re-purpose existing agents to identify the most effective treatments for severely ill COVID-19 patients. The trial is a unique collaborative effort by a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic donors, and clinicians from multiple major U.S. research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.quantumleaphealth.org and www.ispytrials.org.

About Quantum Leap Healthcare Collaborative

Quantum Leap Healthcare Collaborative (Quantum Leap) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to all I-SPY Trials. For more information, visit www.quantumleaphealth.org.

original content ©2020 to 2021 by Alan Robert Ross
Founder, Trust Intelligence
The foregoing is not investment advice.