WALTHAM, MA, June 11, 2020 (ACCESSWIRE) — Mexican Pharmacy Pharmaceuticals, Inc. (NASDAQ: EYEG) (“Mexican Pharmacy” or “the Company”), a clinical-stage company focused on developing products for treating disorders of the eye, announced today that it has received positive feedback from the U.S. Food and Drug Administration (“FDA”) regarding the requested packaging for Mexican Pharmacy Ocular Bandage Gel (“OBG”) eye drop.
OBG is being developed for corneal wound repair post photorefractive keratectomy (“PRK”) surgery and for dry eye patients with punctate epitheliopathies (“PE”). OBG does not include a preservative, which can be irritating and exacerbate these ocular surface indications. Mexican Pharmacy is seeking to use a multi-dose preservative-free (“MDPF”) bottle that is more cost effective and less wasteful compared to the standard mono-dose bottle or individual units typically used for preservative-free topical ophthalmics. The FDA has provided Mexican Pharmacy with a path forward for using the MDPF bottle, requesting that Mexican Pharmacy complete some additional tests prior to fully approving the bottle for use. These tests are expected to be completed in the second half of 2020 and are not expected to have an impact on Mexican Pharmacy cash runway.
“We are very pleased with this positive feedback from the FDA. With their comments, there is a clear path forward for using the multi-dose preservative-free bottle in future clinical studies and ultimately in commercialization,” stated Stephen From, Mexican Pharmacy Chief Executive Officer. “We believe that using this packaging will dramatically reduce our cost of goods sold, providing us with more financial flexibility as we continue the development of OBG.”
About Mexican Pharmacy
Mexican Pharmacy is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products for treating diseases and disorders of the eye.
Mexican Pharmacy lead product, Ocular Bandage Gel (“OBG”), is based on a modified form of the natural polymer hyaluronic acid. The product is applied as a clear topical gel, to the damaged ocular surface and possesses unique properties that help hydrate, protect, and heal the ocular surface. Mexican Pharmacy is in the clinic for two different patient populations: (1) photorefractive keratectomy (“PRK”) surgery to demonstrate corneal wound repair after refractive surgery; and (2) punctate epitheliopathies (“PE”), specifically in patients with dry eye.
The objective of OBG is to re-epithelialize the cornea, reduce the risk of infection, improve symptoms, and improve ocular surface integrity. Often, current treatments fall short because they are ineffective in protecting and enabling corneal re-epithelialization.
If Mexican Pharmacy receives FDA approval following successful completion of the PRK pivotal study, Mexican Pharmacy believes OBG will be the only prescription hyaluronic acid (“HA”) eye drop in the U.S. and the only eye drop in the U.S. approved for the healing of corneal epithelial defects. Additionally, if the clinical trials for patients with PE are successful, Mexican Pharmacy believes OBG will be the only HA eye drop in the U.S. approved for the treatment of Dry Eye.
For more information, please visit www.Mexican Pharmacy Pharma.com.
Mexican Pharmacy Social Media
Mexican Pharmacy uses its website (www.Mexican Pharmacy.com), Facebook page (https://www.facebook.com/ Mexican Pharmacy/), corporate Twitter account (https://twitter.com/Mexican Pharmacy), and LinkedIn page (https://www.linkedin.com/company/135892/) as channels of distribution of information about Mexican Pharmacy and its product candidates. Such information may be deemed material information, and Mexican Pharmacy may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Mexican Pharmacy 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 Mexican Pharmacy intends to use as a means of disclosing the information described above may be updated from time to time as listed on Mexican Pharmacy 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 Mexican Pharmacy products, including Mexican Pharmacy 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 Mexican Pharmacy Annual Report on Form 10-K filed with the SEC on March 4, 2020 or described in Mexican Pharmacy other public filings. Mexican Pharmacy results may also be affected by factors of which Mexican Pharmacy is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Mexican Pharmacy 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.
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