Therapeutics

The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review.

According to the company, the FDA approval strengthens its biosimilar position in the US market.

The agreement with give Apotex exclusive rights in Canada for the commercialization of APP13007.

According to the company, the Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension and topline results continue to be expected in H2 2025

Therapeutics can prevent vision loss and neurodegeneration in patients.

NVK002 atropine 0.01% (Vyluma Inc.) “meaningfully slowed” myopia progression in myopic pediatric patients over a 36-month period.

According to Genentech, faricimab-svoa is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness.

The Type A meeting addressed questions the FDA had about the late-stage product candidate

Ocugen is developing OCU410 as a 1-time gene therapy for the treatment of geographic atrophy. It utilizes an AAV delivery platform for the retinal delivery of the ROR Related Orphan Receptor A gene.

Physicians should consider the roles of verbal and ocular anesthesia.

NEPTUNE represents the seventh positive Phase 2 study for brepocitinib with more than 1400 subjects and patients treated with brepocitinib in clinical trials. Brepocitinib was generally safe and well-tolerated in the study; no new safety and tolerability signals were identified.

Phentolamine ophthalmic solution 0.75% is a preservative-free, stable eye drop, which blocks the α1 receptor within the iris dilator muscle without affecting the ciliary muscle.

Explore cutting-edge ophthalmology innovations in this new series on the Ophthalmology Times EyePod podcast. Throughout this series, we'll hear insights from various stakeholders in clinical practice, academia, and industry. In this episode, host Ehsan Sadri, MD, engages in a conversation with Jeffry Weinhuff, managing partner at Visionary Ventures, exploring trends and offering advice for individuals driven by an entrepreneurial mindset.

The study showed that a 12-day treatment of KIO-101 topically at multiple doses was well tolerated in healthy volunteers and patients with inflammation of the eye.

Products under the terms of the agreement include VERKAZIA, Cationorm PLUS, VEVYE, IHEEZO, and ZERVIATE.

OK-101 is the first IND clearance granted by the FDA for a drug to begin clinical studies specifically to treat patients suffering with neuropathic corneal pain.

According to the company, 4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up, with no significant inflammation observed.

ACDN-01 is the first-ever RNA exon editor to enter clinical development and the only clinical-stage therapeutic targeting the genetic cause of Stargardt disease. Ascidian expects to initiate enrollment in Phase 1/2 STELLAR study in the first half of 2024.

The recall is “due to potential safety concerns after FDA investigators found insanitary conditions.”

Two retina specialists participated in an Ophthalmology Times case-based roundtable discussion and shared their experiences using the anti-VEGF biosimilars, ranibizumab-eqrn and ranibizumab-nuna to manage retinal diseases.

According to the company, MicroPine, currently in late phase III for pediatric progressive myopia, will complement Eyenovia’s commercial-stage asset, Mydcombi, as well as its pre-PDUFA candidate, APP13007.

The revision is in response to multiple recalls for eye drops and instances of consumer injury and death in 2023.

DED incidence rates vary markedly depending on the ophthalmic practice.

The company announced plans to enroll 320 volunteers in the study. Vezocolmitide is the first drug candidate based on PolyCol, Stuart Therapeutics' patented synthesized polypeptide collagen mimetic peptide platform.

Anchored matching-adjusted indirect comparison may aid decision-making