Commercial-stage pharmaceutical company EyePoint Pharmaceuticals Inc. (EYPT:NASDAQ), which is engaged in developing and commercial-
izing therapeutics for serious eye disorders, announced "six-month interim data from the Phase 1 Durasert® and Vorolanib in Ophthal-
mology (DAVIO) clinical trial of EYP-1901, a bioerodible sustained delivery intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment targeting wet age-related macular degeneration (wet AMD)."
The company advised that the data was presented during the American Academy of Ophthalmology's Annual Meeting on the Retina Subspecialty Day held in New Orleans on Saturday, November 13, 2021. The presentation was delivered by David S. Boyer, M.D., Sr. Partner at Retina-Vitreous Associates Medical Group and adjunct clinical professor of Ophthalmology with the USC/Keck School of Medicine.
EyePoint Pharmaceuticals stated that after six months of treatment with EYP-1901 in the study, there were no dose limiting toxicities or any ocular or drug-related serious adverse events recorded. The company highlighted that in the trial, "76% and 53% of patients were rescue-free up to four and six months, respectively, following a single injection of EYP-1901."
The company's CEO Nancy Lurker stated, "We are very encouraged by these data that reinforce EYP-1901's positive safety profile and its durable anti-VEGF activity up to six months so far in the majority of enrolled patients after a single intravitreal injection…Wet AMD is a leading cause of blindness, and these data bring us one step closer to potentially changing the standard of care for patients by offering an in-office sustained delivery treatment option with the potential for up to every six-month dosing."
The company described EYP-1901 as "a sustained delivery anti-VEGF (voralanib) investigational treatment that utilizes a bioerodible formulation of its Durasert® drug delivery technology." The firm noted that Durasert® has already been approved for use in four other products by the U.S. Food and Drug Administration (FDA) including its YUTIQ® for treating chronic non-infectious uveitis which affects the posterior segment of the eye.
The Phase 1 DAVIO clinical study of EYP-1901 enrolled a total of 17 patients who had previously undergone treatment for wet AMD. There were no adverse effects experienced in the study, nor were there reports of any other adverse results such as endophthalmitis, implant migration in the anterior chamber, posterior segment inflammation, vitreous floaters, retinal detachments or retinal vasculitis.
EyePoint Scientific Advisory Board Member and DAVIO Clinical Investigator David S. Boyer, M.D., commented, "We are very encouraged by today's data results, which demonstrated the safety and sustained anti-VEGF activity of EYP-1901 in wet AMD patients…Seeing treatment improvements for these patients is very promising, and we look forward to starting the next phase of this development program next year."
EyePoint Pharma' COO Jay S. Duker, M.D., remarked, "Our clinical trial includes patients with previously treated wet AMD, who received frequent anti-VEGF injections prior to entering DAVIO. We were thrilled to see how well tolerated the EYP-1901 inserts appear to be and how well patients responded to EYP-1901 for both vision and anatomical endpoints over the six-month interim report of this 12-month study. These results are not only promising as we plan to move EYP-1901 into Phase 2 in wet AMD, but also for the potential to change the treatment paradigm for many wet AMD patients…We are encouraged by responses to date and will continue to monitor the progress of these patients as they complete the second half of this trial."
The firm indicated that it intends to launch a Phase 2 wet AMD clinical trial during 2022 and has lined up a Type C meeting at the beginning of December with the U.S. Food and Drug Administration (FDA) to present its plans and obtain guidance regarding potential EYP-1901 registration trials. The firm noted that it also plans to proceed with additional clinical studies for EYP-1901 clinical trials for treating diabetic retinopathy (DR) and retinal vein occlusion.
According to the company, the two basic types of age-related macular degeneration, "dry" (atrophic) and "wet" (exudative), combined impact up to 11 million people in the U.S. The firm noted that approximately 15% of those individuals are afflicted with wet AMD, which can often lead to blindness. Currently, the standard approach to wet AMD treatment is administering intravitreal injections monthly or bi-monthly which presents ongoing challenges for both patients and doctors.
EyePoint is a pharmaceutical company headquartered in Watertown, Mass. that is focused on developing and commercializing medicines for treating serious eye disorders. The form has developed proprietary intraocular drug delivery technology which it calls Durasert® that it is using in its drug pipeline candidate, EYP-1901, as a potential semi-annual intravitreal anti-VEGF treatment designed to address wet AMD. The firm's FDA approved products include YUTIQ®, for chronic non-infectious uveitis and DEXYCU® for treatment postoperative inflammation after ocular surgery.
EyePoint Pharmaceuticals began the day with a market cap of around $403.1 million with approximately 28.77 million shares outstanding and a short interest of about 5.3%. EYPT shares opened 37% higher today at $19.25 (+$5.24, +37.40%) over Friday's $14.01 closing price and reached a new 52-week high price this morning of $21.50. The stock has traded today between $14.10 and $21.50 per share and closed at $14.30 (+$0.29, +2.07%).
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