Melt Pharmaceuticals Inc. today announced positive topline results from its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery.According to the company, based on a Special Protocol Assessment agreement with the FDA earlier this year, the study design and … [Read more...] about Melt Pharmaceuticals reports positive Phase 3 topline efficacy results for MELT-300
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Innovation and the clinician-scientist
Innovation in ophthalmology often arises from unexpected sources, driven by collaboration between researchers and clinicians. Here, 2 pioneering clinician-scientists specializing in the cornea share their insights on the origins of their innovations, the journey to realization, and the essence of being a clinician-scientist.Edward J. Holland, MD: The seed of innovation often … [Read more...] about Innovation and the clinician-scientist
Connect, learn, and innovate in a family-friendly atmosphere: What to expect at EnVision Summit 2025
The EnVision Summit, co-founded by Bonnie An Henderson, MD, is a unique family-friendly, multispecialty CME ophthalmology conference, along with a newly introduced optometry track. Henderson sits down with Ophthalmology Times' Sheryl Stevenson, group editorial director - eye care, to talk about the 2025 conference that will take place February 14 to 17 at the Caribe Hilton San … [Read more...] about Connect, learn, and innovate in a family-friendly atmosphere: What to expect at EnVision Summit 2025
European Commission approves Opuviz as aflibercept biosimilar
November 19, 2024 1 min read Key takeaways: Opuviz was approved in Europe for wet AMD and vision loss related to other retinal conditions. It is the second European-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership. The European Commission has approved Opuviz 40 mg/mL solution, a biosimilar referencing … [Read more...] about European Commission approves Opuviz as aflibercept biosimilar
Study of atropine-based myopia treatment fails to meet primary efficacy endpoint
November 19, 2024 1 min read Eyenovia’s phase 3 CHAPERONE study evaluating low-dose atropine delivered via the company’s Optejet dispenser is not meeting its primary endpoint of a less than 0.50 D progression in visual acuity over 3 years, according to a press release. “We are disappointed that the [Data Review Committee (DRC)] determined that the CHAPERONE study does … [Read more...] about Study of atropine-based myopia treatment fails to meet primary efficacy endpoint
VIDEO: ONL1204 has different approach for treatment of geographic atrophy
November 19, 2024 1 min watch CHICAGO — In this video, Joan W. Miller, MD, chair of ophthalmology at Mass Eye and Ear, discusses study results presented at the AAO meeting on ONL1204 from ONL Therapeutics. “It’s a very different approach, really more of a neuroprotective approach for [geographic atrophy] and that I think is kind of exciting,” Miller said. Published … [Read more...] about VIDEO: ONL1204 has different approach for treatment of geographic atrophy
FDA accepts NDA from Aldeyra Therapeutics for reproxalap for dry eye
The FDA has accepted the resubmitted new drug application (NDA) from Aldeyra Therapeutics for its first-in-class investigational candidate, topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease. At the same time, Aldeyra is choosing to expand their option agreement with AbbVie, granting the manufacturer more cash to bring the drug to … [Read more...] about FDA accepts NDA from Aldeyra Therapeutics for reproxalap for dry eye
SpyGlass Pharma completes enrollment in Phase I/II study of its long-term drug delivery platform for glaucoma and ocular hypertension
SpyGlass Pharma today announced completion of enrollment in its Phase I/II, randomized, multi-center, controlled clinical trial (NCT06120842) evaluating SpyGlass’ drug delivery platform in patients with glaucoma or ocular hypertension.According to the company, its platform is designed to deliver multiple years of bimatoprost to lower intraocular pressure (IOP) and is implanted … [Read more...] about SpyGlass Pharma completes enrollment in Phase I/II study of its long-term drug delivery platform for glaucoma and ocular hypertension
Adverum reports positive 52-week, 4-year data for wet AMD gene therapy
November 19, 2024 1 min read Adverum Biotechnologies reported positive 52-week data from the phase 2 LUNA trial as well as long-term follow-up results from the OPTIC trial of Ixo-vec in patients with wet age-related macular degeneration. “Today’s clinical updates underscore Ixo-vec’s potential best-in-class product profile in wet AMD and highlight that we have … [Read more...] about Adverum reports positive 52-week, 4-year data for wet AMD gene therapy
FDA issues CRL to Astellas’ Supplemental New Drug Application for avacincaptad pegol intravitreal solution (IZERVAY)
Astellas Pharma Inc. announced the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for avacincaptad pegol intravitreal solution (IZERVAY). In the November 15 CRL, the FDA stated it cannot approve a supplemental New Drug Application in its present form. IZERVAY had an expected Prescription Drug User Fee Act (PDUFA) date of November … [Read more...] about FDA issues CRL to Astellas’ Supplemental New Drug Application for avacincaptad pegol intravitreal solution (IZERVAY)