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Each month, our editorial staff compiles a recap of the top news in ophthalmology. Our December 2023 month-in-review features a recap of This Year in Medicine, the latest updates to the ophthalmic pipeline, and the newest episode of our KOL-led podcast series.
A historic year in ophthalmology certainly did not slow down in the last quarter of the year. To mark the end of the calendar year, the HCPLive Ophthalmology team compiled a list of our 7 top stories in ophthalmology in December to provide more insight into our coverage of eye care. Our December 2023 month-in-review in ophthalmology includes a trio of features from our This Year in Medicine series, the final updates to the pipeline in 2023, and the latest episode of our KOL-led ophthalmology podcast series, New Insight with Veeral Sheth, MD.
At the end of each year, HCPLive and its sister publications collaborate to produce feature content for the This Year in Medicine series. The series offers a chance to contemplate the year of developments and challenges across medicine, and lock in the landmarks that defined the year in each medical specialty.
In 2023, the eye care space was host to watershed approvals and distressing safety reports. A trio of features for This Year in Medicine tackled the most important developments of the year, recalls related to common ophthalmic products, and safety reports related to a historic treatment approval.
A landmark year in medicine can be defined by how groundbreaking innovations or revolutionary tools reshape and remake clinical practice, and embody a better tomorrow for patient care. Leading KOLs in eye care and beyond described the defining moment of the year and how 2023 will pave the way for the future of ophthalmology.
Over-the-counter eye drops were a major point of concern for both the medical field and consumers, as reports of eye infections, and even death, were linked to artificial tears, including those sold by major brands, such as CVS Health and Rite Aid. Safety warnings from the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) led to the recall of dozens of ophthalmic drug products and increased vigilance towards OTC products sold online.
The FDA approval of pegcetacoplan injection (SYFOVRE) from Apellis Pharmaceuticals marked the first agent approved for treating geographic atrophy (GA) secondary to age-related macular degeneration. However, reports of retinal vasculitis linked to pegcetacoplan injection left the retina community concerned about its benefit-to-risk profile and what the drug could mean for patients.
A robust pipeline for ophthalmology maintained its impressive showing in December, with encouraging new trial data and FDA approvals marking the month. A glimpse into the pipeline's future added to the month's highlights.
Topline results from the phase 2 DAVIO 2 trial showed EYP-1901, a sustained delivery maintenance treatment combining vorolanib with a bioerodible insert, achieved all primary and secondary endpoints in the treatment of wet AMD.
Announced by Eyepoint Pharmaceuticals on December 7, 2023, results from DAVIO 2 showed a statistical non-inferiority change in best-corrected visual acuity (BCVA) with EYP-1901 compared to aflibercept, and a favorable safety profile.
On December 14, 2023, the FDA approved NDA for a single administration of travoprost intracameral implant (iDose® TR), a long-duration prostaglandin analog indicated for intraocular pressure reduction among patients with ocular hypertension or open-angle glaucoma.
Granted to Glaukos, the first-of-its-kind intracameral implant is designed to continuously deliver therapeutic levels of travoprost inside the eye for extended durations of time.
Announced on December 19, 2023, Outlook Therapeutics submitted a Special Protocol Assessment (SPA) request to the FDA for a required additional study of ONS-5010, an ophthalmic bevacizumab formulation indicated for the treatment of nAMD.
The FDA is expected to submit a response to the SPA in early February 2024 and Outlook Therapeutics plan to resubmit the ONS-5010 Biologics License Application by the end of calendar year 2024.
Before the end of 2023, HCPLive Ophthalmology's podcast series hosted by Veeral Sheth, MD, the director of clinical research at University Retina and Macula Associates, successfully wrapped its inaugural 10-episode season. But, for a first look at what's to come in 2024, HCPLive Ophthalmology released the first episode of the second season.
In this episode, Sheth spoke with George Magrath, MD, the chief executive officer and board member of Ocuphire Pharma, on the company’s flagship retinal product, APX3330 for diabetic retinopathy. The company recently met with the FDA for an end-of-phase 2 meeting, supporting the advancement of APX3330 into phase 3 trials. In the episode, the two retina specialists discussed the company’s preparations for the phase 3 clinical trial program, Magrath’s background and journey across eye care, and expert insight into leading a small, but high-functioning research team.