Therapeutics

According to the company, Duravyu 2.7 mg demonstrated an early and sustained anatomical improvement mirroring BCVA results with a 68 micron reduction in CST. Full topline data is anticipated in Q1 of 2025.

According to the company, the second Phase 3 LUCIA pivotal trial first patient dosing is expected by end of 2024 with topline data anticipated in 2026.

According to OKYO Pharma, OK-101 is the first drug candidate to enroll patients specifically diagnosed with neuropathic corneal pain in a clinical trial. The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients.

According to the company, its data replicate and expand upon the potential of ER-100 to improve retinal ganglion cell function and restore visual function in a nonhuman primate model of nonarteritic anterior ischemic optic neuropathy.

New research presented at the American Academy of Ophthalmology’s Cornea Subspecialty Day is part of the part of the 8-year Zoster Eye Disease Study.

According to the company, the axitinib injectable suspension achieved all primary and secondary outcomes and maintained stable visual acuity and anatomical control over 9 months.

According to the company, a $68 million Series D financing is co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC Inc. It also has secured $15 million in structured capital from Catalio Capital Management, with $10 million drawn at closing.

Marketed as Triesence, it is a preservative free synthetic corticosteroid that is approved by the FDA for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

Clobetasol is FDA-approved for the treatment of post-operative inflammation and pain following ocular surgery.

Aflibercept biosimilars have cleared several hurdles on their way to marketplace

Push to identify biomarkers for earlier diagnosis, new therapeutic targets.

APP13007, according to the company, is the first product developed using Formosa’s proprietary APNT nanoparticle formulation platform.

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.

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.”