Ophthalmology

Veeral Sheth, MD, is joined by the CEO of Neurotech to discuss the historic approval of revakinagene taroretcel (ENCELTO) for macular telangiectasia type 2.

Our top 5 headlines featured an oral drug delivering 16% weight loss, notable blood pressure reductions from a hypertension treatment, and 3 key FDA decisions.

ATSN-201 gene therapy has previously received Rare Pediatric Disease and Orphan Drug designations from the regulatory agency.

Our top 5 headlines include 5 key FDA decisions, including the first approval for stroke in 3 decades, an expanded indication for pediatric anaphylaxis, and more!

With this historic approval, revakinagene taroretcel (ENCELTO) becomes the first and only FDA-approved treatment for MacTel.

Veeral Sheth, MD, is joined by the CEO of Oculis to discuss the company's ophthalmic pipeline, including OCS-01 for DME and OCS-05 for acute optic neuritis.

The February 2025 month in review covers 7 key pipeline updates in ophthalmology, including regulatory approvals, label expansions, and topline trial results.

Eyelid pressure patching concomitantly with a decellularized, dehydrated amniotic membrane could prove a novel method to address PCED.

Epioxa has been assigned a target action date of October 20, 2025, for the regulatory agency’s review of the NDA.

The first of two Phase 3 pivotal trials investigating sozinibercept, COAST completed its final week 52 visit in patients with wet AMD.

Alvotech and Teva expect the review to be completed in the fourth quarter of 2025.

Awarded to Luxa Biotechnology, early clinical from the first cohort of patients with dry AMD will be presented at an upcoming medical meeting.

Our top 5 headlines include a target date for a cholesterol-lowering drug, long-term dermatology data, and an expanded dosing label for geographic atrophy.

The FDA approved an expanded label for avacincaptad pegol, removing limitations on the duration of dosing beyond 12 months.

The January 2025 ophthalmology month in review highlights the latest from the FDA, key updates to the ophthalmic pipeline, and the latest episode of New Insight.

Both doses of DURAVYU extended the time to the first supplemental injection versus aflibercept control in the Phase 2 VERONA trial.

Elevated HDL-C raised glaucoma risk, particularly for participants aged ≥55 years, contrary to its typical beneficial role in cardiovascular health.

The FDA’s approval marks the second indication for Genentech's refillable ocular implant in addition to wet age-related macular degeneration.

Awarded to Beacon Therapeutics, RMAT designation allows enhanced communications with the FDA across the development of the investigational gene therapy.

In this episode, Veeral Sheth, MD, is joined by the CEO of Orasis Pharmaceuticals to discuss Qlosi, a preservative-free, low-dose eye drop FDA-approved for presbyopia.

With a completed 12-week analysis, Outlook Therapeutics plans to resubmit the Biologics License Application for ONS-5010 in the first quarter of 2025.

With a Phase 3 trial expected in 2025, linsitinib is the first oral small-molecule therapy to demonstrate statistical significance in thyroid eye disease.

Samsara Vision announced the implantable miniature telescope improved distance and near vision 6 months post-surgery for patients with late-stage AMD.

All participants with RP treated with OCU400 gene therapy achieved vision improvement or preservation at 2 years of the Phase 1/2 trial.

4D-150 shows promising efficacy and safety in DME as FDA greenlights Phase 3 trial for Biologics License Application submission.