EyeGate Pharma Announces Positive Results in Second PRK Study
13 11월 2018 - 8:55PM
Data confirms results from earlier
study
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) today announced
top-line data from its study evaluating the potential of EyeGate’s
Ocular Bandage Gel (OBG) to help clinicians better manage corneal
epithelial defects in patients following photorefractive
keratectomy (PRK) surgery, compared to current standard of care.
Daniel S. Durrie, M.D., Founder, Durrie Vision in Overland Park,
KS, said, “This is the first time I have seen a product heal an
epithelial defect without a bandage contact lens. Working with PRK
patients creates an ideal epithelial defect challenge model to
demonstrate the potential to heal all types of ocular surface
wounds.”
The PRK study enrolled 45 subjects undergoing a bilateral PRK
procedure. The trial was designed to assess safety and efficacy by
comparing two dosing regimens of EyeGate’s OBG to the current
standard of care, a bandage contact lens plus artificial tears. The
efficacy assessments included the percentage of subjects achieving
complete wound healing on day 3 and day 4 and wound size on day 3.
These assessments were evaluated by an independent masked reading
center, using digital slit-lamp photographs of fluorescein staining
in all treated eyes, and a protocol-driven method in order to
quantify the outcomes.
Both of the OBG dosing regimens outperformed the standard of
care in the number of eyes healed at day 3 and day 4 post-surgery.
At day 3, 73% and 87% of eyes receiving the two OBG treatment
regimens were completely healed compared with 67% for
standard-of-care. At day 4 post-surgery, 100% in both OBG treatment
groups were completely healed, vs. 87% in the standard-of-care
comparator group. Additionally, the maximum wound size was 67% and
49% smaller at day 2 post-surgery for the two OBG groups compared
to the standard-of-care. Importantly, there were no safety concerns
observed in any group.
Stephen From, CEO of EyeGate, said, “We are very pleased with
the data from this second PRK study, which demonstrated the ability
to replicate the data from our first study. This data showed a
similar magnitude and rate of response reinforcing our belief that
OBG has the potential to manage the healing of epithelial corneal
wounds. Consequently, we believe that all of our data is sufficient
and robust enough to create a path toward regulatory filings for
approval and commercialization.”
About EyeGate EyeGate is a clinical-stage
specialty pharmaceutical company focused on developing and
commercializing products using its two proprietary platform
technologies for treating diseases and disorders of the eye.
EyeGate’s OBG platform is based on a crosslinked thiolated
carboxymethyl hyaluronic acid (CMHA-S), a modified form of the
natural polymer hyaluronic acid, which is a gel that possesses
unique physical and chemical properties such as hydrating and
healing when applied to the ocular surface. The ability of CMHA-S
to adhere longer to the ocular surface, resist degradation and
protect the ocular surface makes it well-suited for treating
various ocular surface injuries including surgical trauma.
EGP-437, EyeGate’s other product in clinical trials,
incorporates a reformulated topically active corticosteroid,
Dexamethasone Phosphate that is delivered into the ocular tissues
through EyeGate’s proprietary innovative drug delivery system, the
EyeGate II Delivery System. For more information, please visit
www.EyeGatePharma.com.
EyeGate Social Media EyeGate uses its website
(www.EyeGatePharma.com), Facebook page
(https://www.facebook.com/EyeGatePharma/), corporate Twitter
account (https://twitter.com/EyeGatePharma), and LinkedIn page
(https://www.linkedin.com/company/135892/) as channels of
distribution of information about EyeGate and its product
candidates. Such information may be deemed material information,
and EyeGate may use these channels to comply with its disclosure
obligations under Regulation FD. Therefore, investors should
monitor EyeGate's website and its social media accounts in addition
to following its press releases, SEC filings, public conference
calls, and webcasts. The social media channels that EyeGate intends
to use as a means of disclosing the information described above may
be updated from time to time as listed on EyeGate's investor
relations website.
Forward-Looking Statements Some of the
statements in this press release are “forward-looking” and are made
pursuant to the safe harbor provision of the Private Securities
Litigation Reform Act of 1995. These “forward-looking” statements
include statements relating to, among other things, the
commercialization efforts and other regulatory or marketing
approval efforts pertaining to EyeGate’s products, including
EyeGate’s EGP-437 combination product and the EyeGate OBG product,
as well as the success thereof, with such approvals or success may
not be obtained or achieved on a timely basis or at all. These
statements involve risks and uncertainties that may cause results
to differ materially from the statements set forth in this press
release, including, among other things, certain risk factors
described under the heading “Risk Factors” contained in EyeGate’s
Annual Report on Form 10-K filed with the SEC on March 2, 2018 or
described in EyeGate’s other public filings. EyeGate’s results may
also be affected by factors of which EyeGate is not currently
aware. The forward-looking statements in this press release speak
only as of the date of this press release. EyeGate expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to such statements to reflect any change in
its expectations with regard thereto or any changes in the events,
conditions or circumstances on which any such statement is
based.
Contact Joseph Green / Andrew Gibson Edison
Advisors for EyeGate Pharmaceuticals 646-653-7030 /
7719jgreen@edisongroup.com / agibson@edisongroup.com
AB Corporate Bond ETF (NASDAQ:EYEG)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
AB Corporate Bond ETF (NASDAQ:EYEG)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024