Retinal Physician

The US Food and Drug Administration (FDA) has accepted and filed Nanoscope Therapeutics’ biologics license application (BLA) for sonpiretigene isteparvovec (Mogenry; MCO-010), an investigational optogenetic gene therapy for patients with retinitis pigmentosa (RP) and severe vision loss. According to the company, a Prescription Drug User Fee Act (PDUFA) date in the first half of 2027 has been issued, and the company is actively preparing to be commercial ready in the first half of 2027.

Recent advances have expanded the role of genetic testing in retinoblastoma beyond the detection of germline mutations. Genetic testing may now contribute to diagnosis and may also provide prognostic information regarding local recurrence and systemic metastasis. For ophthalmologists, understanding these emerging applications is essential for counseling patients and families, identifying children at risk, and ensuring appropriate early intervention.

Despite excellent local control of uveal melanoma, nearly 40% of patients develop metastatic disease over the long term.1 Molecular testing of tumor DNA and RNA has become integrated into clinical practice by stratifying patients into low-risk and high-risk categories for metastasis based on characteristic chromosomal and transcriptional signatures.2 For example, gene expression profiling (GEP) is broken down into class 1 and 2 with ascending risk of metastasis.3 However, DNA and RNA are...

Ocular tumor coding can be challenging because ocular oncology often involves evolving lesions, diagnostic uncertainty, and terminology that does not always translate cleanly into ICD-10-CM codes. Terms such as “suspicious lesion,” “pigmented mass,” or “possible melanoma” may reflect clinical concern, but diagnosis coding does not allow “rule-out” coding. Instead, the diagnosis code must reflect the condition documented at the time of the visit.

Michael A. Singer, MD, interviews Inflammasome Therapeutics co-founder Jayakrishna Ambati, MD, about kamuvudine-8 (K8), an investigational dual-inflammasome inhibitor being developed for geographic atrophy (GA).

Jay S. Duker, MD, discusses LUGANO’s missed primary endpoint, EyePoint’s ad hoc analysis of the data, and what the findings could mean for the ongoing phase 3 wet AMD program and Duravyu’s development in DME. On August 17, EyePoint, Inc. reported topline results from the phase 3 LUGANO trial of Duravyu (vorolanib intravitreal insert, or EYP-1901) for neovascular (wet) age-related macular degeneration (AMD).

Zeiss Medical Technology announced the 510k clearance from the US Food and Drug Administration (FDA) for Zeiss Clinic 360, an all-in-one cloud and browser-based software solution. According to a company press release, Zeiss Clinic 360 combines diagnostic and medical data into a comprehensive patient view that allows clinicians to evaluate disease progression, support treatment decisions, and improve workflow efficiency.

EyePoint reported top-line results from the phase 3 LUGANO trial of Duravyu (vorolanib intravitreal insert) 2.7 mg in patients with wet age-related macular degeneration (AMD). The study missed its primary endpoint in the full dataset but met several secondary endpoints. The primary endpoint assessed change from baseline in best-corrected visual acuity compared with on-label 2 mg aflibercept. Duravyu did not achieve noninferiority in the full analysis.

A post hoc analysis of the phase 3 GATHER2 trial, presented at the 2026 American Society of Retina Specialists meeting in Montreal, provides additional evidence linking retinal structure and visual function in geographic atrophy (GA). Investigators found that ellipsoid zone (EZ) integrity and low-luminance deficit (LLD) moved in parallel, supporting their use as complementary markers of disease progression and treatment response. Rachel A.

There is a fine balance between confidence and panic after someone in the business office resigns. Some people remain calm, convinced that a replacement is readily at hand—they just need to hire them. Post the ad, and in a week you will have a new employee. That is the equivalent of waving a magic wand and having a replacement appear. It is a lovely thought, but, sadly, it is not how things work.