$EYEG Receives Approval from FDA to Initiate PRK P
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Posted On: 06/03/2019 9:45:46 AM
$EYEG Receives Approval from FDA to Initiate PRK Pivotal Study
WALTHAM, MA / ACCESSWIRE / June 3, 2019 / EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) ("EyeGate" or "the Company"
announced today it has received approval from the U.S. Food and Drug Administration ("FDA" to initiate its photorefractive keratectomy ("PRK" pivotal study. The FDA has determined that EyeGate provided sufficient data to support initiation of the clinical study and has requested that EyeGate make some modifications to the patient informed consent document prior to enrollment. EyeGate will address these modifications immediately and expects enrollment to begin this month.
Stephen From, CEO of EyeGate, said, "We are extremely pleased with the feedback received from the FDA regarding the design of our PRK pivotal study and plan to begin enrollment as soon as possible. We expect to receive topline results by year-end 2019 and, assuming these are positive, plan to submit the de novo application for commercialization shortly thereafter. Our OGB platform, if approved, will be the first prescription Hyaluronic Acid ("HA" eyedrop formulation in the U.S. market providing a huge opportunity for us."
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 development, 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.
WALTHAM, MA / ACCESSWIRE / June 3, 2019 / EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) ("EyeGate" or "the Company"
announced today it has received approval from the U.S. Food and Drug Administration ("FDA" to initiate its photorefractive keratectomy ("PRK" pivotal study. The FDA has determined that EyeGate provided sufficient data to support initiation of the clinical study and has requested that EyeGate make some modifications to the patient informed consent document prior to enrollment. EyeGate will address these modifications immediately and expects enrollment to begin this month. Stephen From, CEO of EyeGate, said, "We are extremely pleased with the feedback received from the FDA regarding the design of our PRK pivotal study and plan to begin enrollment as soon as possible. We expect to receive topline results by year-end 2019 and, assuming these are positive, plan to submit the de novo application for commercialization shortly thereafter. Our OGB platform, if approved, will be the first prescription Hyaluronic Acid ("HA"
eyedrop formulation in the U.S. market providing a huge opportunity for us." 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 development, 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.
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Anything I write is pure gibberish...perhaps thought provoking and fun...but investment advice??? I don't think so.