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The US Food and Drug Administration (FDA) has cleared GenEditBio Limited’s Investigational New Drug (IND) application to...
01/05/2026

The US Food and Drug Administration (FDA) has cleared GenEditBio Limited’s Investigational New Drug (IND) application to initiate phase 1/2 CLARITY trial activities for its lead in vivo genome-editing program GEB-101 for TGFBI corneal dystrophy.

TGFBI corneal dystrophy is a group of genetic eye disorders caused by mutations in the TGFBI gene, resulting in abnormal protein buildup in the stromal layer of the cornea. Current treatment options include phototherapeutic keratectomy and corneal transplantation.

The company can now initiate its phase 1/2 CLARITY trial activities for its lead in vivo genome-editing program GEB-101 for TGFBI corneal dystrophy.

Outlook Therapeutics, Inc. reported that the FDA has issued a complete response letter (CRL) concerning the resubmitted ...
01/05/2026

Outlook Therapeutics, Inc. reported that the FDA has issued a complete response letter (CRL) concerning the resubmitted biologics license application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg). The letter noted that the agency cannot approve the application in its current form for the treatment of wet age-related macular degeneration (wet AMD).

The FDA stated in the CRL that the additional mechanistic and natural history data included in the BLA resubmission did not change its prior review conclusion, according to Outlook Therapeutics. Although the single adequate and well-controlled study demonstrated efficacy, the FDA again recommended that confirmatory evidence of efficacy be submitted to support the application, without indicating what type of confirmatory evidence would be acceptable.

The letter noted the FDA is unable to approve the application for ONS-5010/LYTENAVA (bevacizumab-vikg) in its current form for the treatment of wet AMD, according to the company.

Inside the clinic: Mujahid A. Hines, MD, NVISION Eye Center in Roseville and Folsom, California, shares real-world exper...
01/04/2026

Inside the clinic: Mujahid A. Hines, MD, NVISION Eye Center in Roseville and Folsom, California, shares real-world experience

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance clinical and patient care.

Achieving a new level of refractive precision: Surgical strategies—Concentric lens positioning of an adjustable lens hel...
01/03/2026

Achieving a new level of refractive precision: Surgical strategies—Concentric lens positioning of an adjustable lens helps avoid a late myopic shift.

Concentric lens positioning of an adjustable lens helps avoid a late myopic shift.

(PRIMA) system implant restored central vision and led to a significant improvement in visual acuity from baseline to mo...
01/02/2026

(PRIMA) system implant restored central vision and led to a significant improvement in visual acuity from baseline to month 12 after implantation in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).1 Frank G. Holz, MD, FEBO, FARVO, and colleagues reported their results in the New England Journal of Medicine. Holz is a vitreoretinal surgeon and chair of the Department of Ophthalmology, University of Bonn, Germany.

This research may represent the first retinal prosthetic device treatment that may restore functional central vision to patients with GA due to AMD.

The novel system converts light into electrical signals to stimulate retinal cells.

From first-in-class pharmacologic therapies to next-generation retinal durability strategies and less invasive surgical ...
01/01/2026

From first-in-class pharmacologic therapies to next-generation retinal durability strategies and less invasive surgical platforms, 2025 emerged as a pivotal year for the ophthalmic pipeline.

Over the past 12 months, the US Food and Drug Administration (FDA) delivered a series of approvals that reshaped treatment paradigms across retina, cornea, cataract, refractive surgery, and ocular surface disease.

An in-depth look at the FDA approvals and clinical milestones that defined 2025 and how they are poised to influence practice patterns moving into 2026.

A recent Ophthalmology Times Case-Based Roundtable focused on extended anti-VEGF treatment durability. Peter K. Kaiser, ...
12/31/2025

A recent Ophthalmology Times Case-Based Roundtable focused on extended anti-VEGF treatment durability. Peter K. Kaiser, MD, served as moderator.

Strategies for treatment intervals, drug selection, and patient expectations.

As the year draws to a close, many clinicians are taking stock of the moments that shaped their practice in 2025. For Ne...
12/30/2025

As the year draws to a close, many clinicians are taking stock of the moments that shaped their practice in 2025. For Neda Shamie, MD—a cataract, LASIK, and corneal surgeon at the Maloney-Shamie-Hura Vision Institute in Los Angeles, California—one patient in particular left a lasting impact. The Eye Care Network caught up with Shamie to reflect on the most challenging case she managed this past year and the lessons it continues to carry forward.

Looking back on 2025, Neda Shamie shares how a challenging monocular patient reinforced the importance of patience, presence, and psychological support in ophthalmic care.

With dry eye disease (DED) presenting ongoing challenges for clinicians and patients, a recent Ophthalmology Times Viewp...
12/29/2025

With dry eye disease (DED) presenting ongoing challenges for clinicians and patients, a recent Ophthalmology Times Viewpoints panel aimed to explore practical strategies for improving management and long-term outcomes.

Kendall Donaldson, MD, MS, from Bascom Palmer Eye Institute in Miami, Florida, moderated the session, which included panelists Cecelia Koetting, OD, FAAO, from the University of Colorado Anschutz Medical Campus, Aurora; Selina McGee, OD, FAAO, who practices in Edmond, Oklahoma; and Karl Stonecipher, MD, in private practice in Greensboro, North Carolina.

Panel examines drug mechanisms, patient factors, and strategies to optimize results.

The year in optometry: 10 stories that defined eye care in 2025—The past year marked a pivotal period for optometry, wit...
12/28/2025

The year in optometry: 10 stories that defined eye care in 2025—The past year marked a pivotal period for optometry, with 2025 delivering meaningful clinical, regulatory, and legislative developments that reshaped eyecare practice.

An overview of the top 10 stories from Optometry Times in 2025.

Artificial intelligence (AI) continues to evolve with improved diagnostic abilities, individualized patient treatments, ...
12/27/2025

Artificial intelligence (AI) continues to evolve with improved diagnostic abilities, individualized patient treatments, and enhanced surgical accuracy. Some key developments include the analysis of retinal scans that provide earlier disease detection and the ability to spot tumors on slit-lamp photographs. Another advance is more individualized cataract surgery thus enhancing precision and visual outcomes.

AI currently is at the forefront of ophthalmologists’ minds. When asked about technologic advances in 2025, a recent survey found that ophthalmologists identified AI as by far the “most transformative trend in ophthalmology.”

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance clinical and patient care.

Extended durability, higher molar dose, fewer injections. From our panel discussion, a trio of retina experts explore ...
12/26/2025

Extended durability, higher molar dose, fewer injections. From our panel discussion, a trio of retina experts explore how aflibercept 8 mg is reshaping treatment strategy for retinal disease. .

A trio of retina specialists recently reviewed the clinical benefits of aflibercept 8 mg, including its extended dosing intervals, improved patient satisfaction, and enhanced treatment outcomes for various conditions.

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