Top line Data expected in Q3 2018
WALTHAM, MA, USA I April 06, 2018 I EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), today announced completion of patient enrollment for the pivotal Phase 3 clinical study of its EGP-437 combination product for the treatment of non-infectious anterior uveitis.
Non-infectious anterior uveitis is characterized by the inflammation of the anterior chamber of the eye. Symptoms may include redness, soreness and inflammation of the eye, blurring of vision, sensitivity to light and a small pupil. If untreated anterior uveitis can cause permanent damage and vision loss.
The double-masked, randomized, positive-controlled trial enrolled 250 patients in the United States. The trial was designed to assess the safety and efficacy of iontophoretically-delivered EGP-437 in patients with unilateral or bilateral non-infectious anterior segment uveitis.
The primary efficacy endpoint of the trial was the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14. Subjects were provided three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment. Patients enrolled in the EGP-437 arm were provided placebo eye drops, while patients receiving placebo iontophoresis treatment are given prednisolone acetate (1%) drops. Eye drops for both arms were administered for a period of up to 28 days and for up to 8 drops per day.
“Completion of patient enrollment in this confirmatory Phase 3 clinical trial evaluating our unique EGP-437 combination product represents a major milestone for the company,” commented Stephen From, President and Chief Executive Officer of EyeGate. “Congratulations to our committed team of trial investigators and coordinators on this critical milestone. We expect top line data in the third quarter and, assuming positive data from this trial, we plan to submit a New Drug Application to the FDA in the first half of 2019.”
In 2015, EyeGate and a subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE:VRX) and (TSX:VRX) entered into an exclusive, worldwide licensing agreement, through which EyeGate granted Valeant worldwide commercial and manufacturing rights, as part of its Bausch + Lomb business, to its EyeGate® II Delivery System and EGP-437 combination product in the field of uveitis. Completion of patient enrollment has triggered a milestone payment from Valeant under this licensing agreement.
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 CMHA-S platform is based on a cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which is an eye drop 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.
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.
SOURCE: EyeGate
Post Views: 98
Top line Data expected in Q3 2018
WALTHAM, MA, USA I April 06, 2018 I EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), today announced completion of patient enrollment for the pivotal Phase 3 clinical study of its EGP-437 combination product for the treatment of non-infectious anterior uveitis.
Non-infectious anterior uveitis is characterized by the inflammation of the anterior chamber of the eye. Symptoms may include redness, soreness and inflammation of the eye, blurring of vision, sensitivity to light and a small pupil. If untreated anterior uveitis can cause permanent damage and vision loss.
The double-masked, randomized, positive-controlled trial enrolled 250 patients in the United States. The trial was designed to assess the safety and efficacy of iontophoretically-delivered EGP-437 in patients with unilateral or bilateral non-infectious anterior segment uveitis.
The primary efficacy endpoint of the trial was the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14. Subjects were provided three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment. Patients enrolled in the EGP-437 arm were provided placebo eye drops, while patients receiving placebo iontophoresis treatment are given prednisolone acetate (1%) drops. Eye drops for both arms were administered for a period of up to 28 days and for up to 8 drops per day.
“Completion of patient enrollment in this confirmatory Phase 3 clinical trial evaluating our unique EGP-437 combination product represents a major milestone for the company,” commented Stephen From, President and Chief Executive Officer of EyeGate. “Congratulations to our committed team of trial investigators and coordinators on this critical milestone. We expect top line data in the third quarter and, assuming positive data from this trial, we plan to submit a New Drug Application to the FDA in the first half of 2019.”
In 2015, EyeGate and a subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE:VRX) and (TSX:VRX) entered into an exclusive, worldwide licensing agreement, through which EyeGate granted Valeant worldwide commercial and manufacturing rights, as part of its Bausch + Lomb business, to its EyeGate® II Delivery System and EGP-437 combination product in the field of uveitis. Completion of patient enrollment has triggered a milestone payment from Valeant under this licensing agreement.
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 CMHA-S platform is based on a cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which is an eye drop 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.
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.
SOURCE: EyeGate
Post Views: 98
