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Aequus Announces Canadian Filing of New Drug Submission (NDS) for Preservative - Free Glaucoma Medication
Thursday, January 13, 2022Company Profile | Follow Company
Health Canada Submission of Preservative-Free Prescription 'Zimed PF' Accepted for Screening
Vancouver, BC, January 13, 2022--(T-Net)--Aequus Pharmaceuticals Inc. (TSX-V:AQS, OTCQB: AQSZF), a specialty pharmaceutical company announced today that it has submitted a New Drug Submission (NDS) application to Health Canada for preservative-free bimatoprost 0.03% eye drops termed 'Zimed PF'. At this stage, Health Canada has accepted the submission for Screening.
"For the first time, a preservative-free glaucoma eye drop, in a multi-dose format, has been submitted for review to Health Canada," says Doug Janzen, Chairman and CEO at Aequus. "We are proud to be the first to take on a submission of this type, and further expand our commitment to innovative and value-added ocular therapies in Canada."
The Zimed PF formulation was selected based on extensive clinical data demonstrating the efficacy and safety of the bimatoprost molecule and0.03% concentration for the reduction of intraocular pressure in patients with ocular hypertension or glaucoma. Upon approval, this preservative-free formulation, will also provide eye care professionals a new option for patients who are sensitive to preservatives or have ocular surface disease.
"Preservative-free glaucoma medications in multi-dose bottles have been well-received by eye care professionals in many countries around the world. Zimed™ PF will provide an environmentally- and patient-friendly format, compared to glaucoma medications only available in single use, plastic ampoules," says Grant Larsen, CCO at Aequus.
According to Health Canada, the target review time for an NDS is 355 days. Aequus is moving ahead with plans in accordance with this timeline but acknowledges that review timing may be affected by factors out of our control such as backlogs caused by COVID-19.
About Aequus Pharmaceuticals
Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF ) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its sales and marketing efforts to include several commercial products in ophthalmology and transplant. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas.
This release may contain forward-looking statements or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect", "potential" and similar expressions. Forward- looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements include but are not limited to statements relating to: the implementation of our business model and strategic plans; revenue growth trends into the future; expected timing for product launches; the Company's expected revenues; the regulatory approval of its products; the Company's ability to attract international partners; and ongoing discussions with and the Company's ability to secure potential partners to further grow our product portfolio. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Aequus, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. [ MORE ] |
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