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FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Outlook Therapeutics’ biologics license application (BLA) resubmission for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD). The recent CRL included only 1 deficiency, for…
Glaucoma techniques advance with innovative viscoelastic delivery
(Image Credit: AdobeStock/rohane) “Modern devices for delivering viscoelastics during viscocanaloplasty have changed greatly over the past few years, resulting in better outcomes with improved ergonomics and user-friendliness for the surgeons who are performing the procedures,” said Edward Yung, MD, of…
Inside the CCOI Myopia Workshop with Assoc Prof Daniel Ting
The CCOI Myopia Workshop in Paris on September 8, 2025, will bring together global experts to address the rising epidemic of myopia. (Image credit: AdobeStock/racesy) As myopia rates continue to climb globally—emerging as a major concern not only in Asia…
Study finds value in home OCT monitoring
(Image credit: AdobeStock/Pixel-Shot) A study published in Ophthalmology Science shows that by analyzing up-to daily home OCT images, artificial intelligence (AI) can accurately track disease activity in patients with wet age-related macular degeneration (AMD). This may allow physicians to manage…
Michael X. Repka, MD, MBA, on building consensus and future directions
In advance of the upcoming CCOI Myopia Workshop, scheduled for September 8 in Paris, France, Michael X. Repka, MD, MBA—program co-chair of the event and current president of the American Academy of Ophthalmology—spoke about the challenges and opportunities facing the…
Surgical innovation in dry eye disease: Salivary gland transplant
(Image Credit: AdobeStock/Alessandro Grandini) Dry eye disease (DED), as defined by the Tear Film and Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II), is a multifactorial disease of the ocular surface. It is characterized by a loss of…
First patient dosed in Qlaris Bio’s phase 2 Nightingale clinical trial for QLS-111
(Image Credit: AdobeStock) The first patient has been dosed in Qlaris Bio’s Phase II Nightingale clinical trial for QLS-111 in patients with normal tension glaucoma (NTG).1 The study, which is Qlaris Bio’s third phase 2 clinical trial of the company’s…
Possible protective role of cannabis in preventing postoperative proliferative vitreoretinopathy after retinal detachment repair
(Image credit: AdobeStock/yellowj) Long-term cannabis use might play a role in reducing proliferative vitreoretinopathy (PVR) development,1 according to first author Ahmed M. Alshaikhsalama, MD. He is from the Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas. He and…
Unpacking high-yield ophthalmology tips and clinical pearls, with Nicole Bajic, MD
In this inaugural episode of iOpeners, host Nicole Bajic, MD, a comprehensive ophthalmologist at the Cole Eye Institute in Cleveland, Ohio, speaks with Bill Trattler, MD, a refractive, corneal, and cataract eye surgeon at the Center For Excellence In Eye…
Meeting expectations with evolving technology
(Image Credit: AdobeStock) As an ophthalmology resident, I am increasingly meeting patients who underwent LASIK surgery 15 or 20 years ago. They were the early adopters of refractive surgery, thrilled to toss their glasses in their youth. Now in their…