Regulatory Roundup FINAL

December 22, 2023 - Regulatory Roundup

Updated every Friday

The FDA has approved the New Drug Application (NDA) for a single administration per eye of travoprost intracameral implant (iDose TR) 75 mcg. According to a statement from drugmaker Glaukos the product is intended to lower IOP in patients with open-angle glaucoma.

The Phase III Diamond-1 trial to evaluate OCS-01 from Oculis is officially underway. The study team achieved first patient first visit: The drug will potentially treat inflammation and pain after cataract surgery.

Azura Ophthalmics announced that its Phase II study of AZR-MD-001, a drop for patients with contact lens discomfort and signs of Meibomian Gland Dysfunction (MGD), met its primary endpoints. Patients in the AZR-MD-001 treatment arm gained at least three hours of comfortable contact lens wear time every day with improvements in tear break-up time and ocular surface staining.

The FDA granted regenerative medicine advanced therapy (RMAT) designation to OCU400 from Ocugen. The gene therapy is designed to treat retinitis pigmentosa associated with RHO mutations.

Clearside Biomedical completed randomization for its Phase IIb Odyssey clinical trial of CLS-AX (axitinib injectable suspension), a product designed to treat wet age-related macular degeneration (AMD). The company expects to have topline results in Q3 2024, according to a company statement.

Outlook Therapeutics is making progress in the advancement of ONS-5010/Lytenava, the investigational ophthalmic formulation of bevacizumab: It submitted a Special Protocol Assessment (SPA) request with the FDA for the required additional adequate and well-controlled study of the wet AMD treatment.

Nicox has screened its first patient in its Phase IIIb trial to investigate the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 to lower IOP. The novel nitric oxide (NO)-donating bimatoprost eye drop is the company’s lead product. Nicox said it plans to enroll about 20 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study that will investigate the action of NCX 470 on aqueous humor parameters, including trabecular meshwork outflow and episcleral venous pressure. Each patient will participate in the trial for about eight days. The trial is expected to take about one year.

Clinical Observations FINAL

December 15, 2023 - Clinical Observations

Updated every Friday

Ophtec, maker of intraocular products, has launched Precizion Go, a hybrid acrylic intraocular lens (IOL) designed to provide distance and enhanced intermediate vision. It’s available in Europe, South Africa and South Korea. Professor Youngsub Eom, MD, PhD, from the Korean University College of Medicine and Ansan Hospital, performed one of the first surgeries in the marketing study. He said, “The…Precizon Go IOL…provides excellent far and intermediate vision without causing dysphotopsia and corrects the corneal positive spherical aberration according to the pupil size." See Precizion Go.

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Rich Kirkner

Rich Kirkner

Contributing Editor
rich@healthegy.com

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