--OMIDRIA demonstrates clear benefits across
traditional and femtosecond laser-assisted cataract surgery and in IFIS
cases--
SEATTLE--(BUSINESS WIRE)--Apr. 19, 2018--
Omeros Corporation (NASDAQ: OMER) announced that the results of four
real-world clinical studies evaluating the benefits of OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1% / 0.3% were
presented at the American Society of Cataract and Refractive Surgery and
American Society of Ophthalmic Administrators Annual Meeting held in
Washington, D.C., April 13-17, 2018. The studies examined the use of
OMIDRIA in both routine and complex cataract surgery cases performed in
high-volume surgery centers, with and without femtosecond laser.
The first presentation, a retrospective analysis, assessed whether the
use of OMIDRIA in femtosecond laser-assisted cataract surgery (FLACS) –
a procedure that is known to cause miosis (pupil constriction) due to
the increased inflammation generated by the laser – leads to a reduction
in the need for pupil expansion devices and in surgical time.
Investigators compared 100 consecutive femtosecond-assisted cataract
procedures in which epinephrine was used in the irrigation solution to
100 consecutive femtosecond-assisted procedures performed with OMIDRIA.
In the epinephrine group, 12 eyes (12 percent) required a Malyugin Ring®
to maintain or improve pupil size versus 2 eyes (2 percent) in the
OMIDRIA group (p=0.009). Surgical times in the OMIDRIA group were
reduced by an average of 78 seconds compared to those in the epinephrine
group (p = 0.007). The authors conclude that use of OMIDRIA achieves
faster surgery and a more manageable pupil.1
The second clinical study assessed the effects of OMIDRIA on pupil
dilation when used early in patients undergoing both FLACS and
traditional cataract surgery. A total of 77 patients underwent either
traditional phacoemulsification (n=57) or FLACS (n=20), all of whom
received OMIDRIA in the irrigation solution and administered through the
side-port incision at the beginning of the case. Pupil diameter was
measured before and after OMIDRIA administration as well as prior to
intraocular lens (IOL) insertion. In the traditional phacoemulsification
cases, the mean pupil diameter was 6.65 mm at baseline and 7.42 mm
intraoperatively before IOL insertion. Similarly, in the FLACS group,
the mean pupil diameter was 6.69 mm at baseline and 7.65 mm prior to IOL
insertion. The study demonstrates that OMIDRIA is effective in
maintaining and even increasing pupil size in traditional as well as in
femtosecond laser-assisted cataract procedures, which, without OMIDRIA,
frequently induce miosis.2
A third study evaluated the effect of OMIDRIA on pupil dilation, iris
billowing and iris prolapse in patients at high risk for intraoperative
floppy iris syndrome (IFIS). The randomized, double-masked,
investigator-initiated study enrolled 50 male subjects (50 eyes) who had
been exposed to tamsulosin (Flomax®), a prostate drug that
causes IFIS, prior to cataract surgery. The 50 patients were randomized
1:1 to receive either OMIDRIA or control. All subjects underwent routine
cataract surgery recorded endoscopically from the perspective of the
ophthalmic microscope. Investigators assessed pupil diameter and IFIS
symptoms in all 50 subjects (50 eyes). Mean pupil diameter during
surgery for the control group was 5.92mm and was 7.08mm for the
OMIDRIA-treated group (p < 0.001). Symptoms of IFIS were observed in all
25 (100 percent) patients in the control group and in only 3 (12
percent) of patients who received OMIDRIA. Iris prolapse occurred in 14
(56 percent) subjects in the control group versus 3 (12 percent) in the
OMIDRIA group. Iris billowing, graded according to a new grading scale
for intraoperative iris abnormalities, averaged 2.36 in the control
group and 1.68 in the treatment group, with Stage 3 (severe) billowing
seen in 10 (40 percent) vehicle subjects and 1 (4 percent) treatment
subject. All of the comparisons related to IFIS symptoms were
statistically significant with p < 0.001. The authors conclude that
OMIDRIA offers significant benefits in IFIS cases and could reduce the
complexity and unpredictability of such cases.3
A fourth study assessed clinical outcomes and surgical practice patterns
for cataract patients treated with either OMIDRIA or epinephrine. This
retrospective chart review included patients who received treatment at
one of two clinics by a single surgeon practicing at both locations. A
total of 635 eyes in 375 patients underwent cataract surgery with either
OMIDRIA (n=275) or epinephrine (n=360) in the irrigation solution. Mean
surgical time was significantly shorter with OMIDRIA versus epinephrine
(16.5 min vs 17.8 min; p = 0.006), and only 6 (2.2 percent) pupil
expansion devices were required in the OMIDRIA group vs 24 (6.7 percent)
in the epinephrine group (p = 0.008). Investigators conclude that
OMIDRIA reduced surgical time and decreased the need for pupil expansion
devices compared to the use of intracameral epinephrine.4
Detailed descriptions of all four clinical studies have been accepted
for publication by, or are planned for submission to, peer-reviewed
journals.
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 (1) to be effective in patients with intraoperative
floppy iris syndrome (IFIS), pseudoexfoliation and other ophthalmic
conditions, (2) to significantly reduce complication rates, use of
pupil-expanding devices, and surgical times, and (3) to significantly
improve uncorrected visual acuity on the first day following cataract
surgery. While OMIDRIA is broadly indicated for use in cataract surgery,
the above outcomes are not in its currently approved labeling. Surgical
time was not an endpoint in the OMIDRIA Phase 3 clinical trials and did
not reach statistical significance in post hoc analysis of the Phase 3
data.
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
In addition to Omeros’ commercial drug OMIDRIA, Omeros has multiple
Phase 3 and Phase 2 clinical-stage development programs focused on:
complement-associated thrombotic microangiopathies; complement-mediated
glomerulonephropathies; Huntington’s disease and cognitive impairment;
and addictive and compulsive disorders. In addition, Omeros has a
diverse group of preclinical programs and a proprietary G
protein-coupled receptor (GPCR) platform through which it controls 54
new GPCR drug targets and corresponding compounds, a number of which are
in preclinical development. The company also exclusively possesses a
novel antibody-generating platform.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934, which are subject to the “safe
harbor” created by those sections for such statements. All statements
other than statements of historical fact are forward-looking statements,
which are often indicated by terms such as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward
to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
“would” and similar expressions and variations thereof. Forward-looking
statements are based on management’s beliefs and assumptions and on
information available to management only as of the date of this press
release. Omeros’ actual results could differ materially from those
anticipated in these forward-looking statements for many reasons,
including, without limitation, risks associated with product
commercialization and commercial operations, unproven preclinical and
clinical development activities, regulatory oversight, intellectual
property claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 1, 2018. Given these risks,
uncertainties and other factors, you should not place undue reliance on
these forward-looking statements, and the company assumes no obligation
to update these forward-looking statements, even if new information
becomes available in the future.
1 Miosis Prevention in Femtosecond-Assisted Cataract
Surgery Using a Continuous Infusion of Phenylephrine and Ketorolac.
Walter K, Delwadia N
2 Effect of Early Phenylephrine
and Ketorolac Injection 1%/0.3% on Pupil Diameter in Traditional and
Femtosecond-Assisted Cataract Surgery. Gayton J.
3
Effect of Phenylephrine and Ketorolac Injection on Intraoperative
Floppy Iris Syndrome. Silverstein S., Rana V.
4 Clinical
Outcomes of Phenylephrine/Ketorolac (1%/0.3%) vs. Epinephrine in
Cataract Surgery in a Real-World Setting. Matossian C.
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Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360-668-3701
jennifer@cwcomm.org