• Thea Pharma announced the FDA approval for the new drug application (NDA) of IYUZEH (latanoprost ophthalmic solution) 0.005%, the first clinically proven formulation of latanoprost available in the United States that is preservative-free, for the reduction of elevated IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). IYUZEH has demonstrated consistent IOP-lowering effects and proven tolerability across multiple trials in the United States and Europe. In randomized, controlled clinical trials of patients with OAG or OHT with mean baseline IOP of 19-24 mm Hg, IYUZEH lowered IOP by 3-8 mm Hg. 

• Amgen announced it is acquiring Horizon Therapeutics, the maker of Tepezza (teprotumumab-trbw) for the treatment of thyroid eye disease in adults and Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder in adults. The deal is valued at $27.8 billion, and Amgen expects the deal to close in the first half of 2023. 

• Harrow entered into a binding agreement for the acquisition of the exclusive US commercial rights to five FDA approved ophthalmic products from the Novartis group of companies. This transaction transfers exclusive US rights to the following ophthalmic products: ILEVRO (nepafenac ophthalmic suspension) 0.3%, NEVANAC (nepafenac ophthalmic suspension) 0.1%, VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5%, MAXIDEX (dexamethasone ophthalmic suspension) 0.1% and TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/ml. The acquisition is expected to close in early 2023.

• The FDA accepted for review Eyenovia Inc.’s NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises the company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation (mydriasis), administered via the investigational Optejet drug delivery technology. The agency assigned the resubmitted NDA a standard review with a Prescription Drug User Fee Act target action date of May 8, 2023. Eyenovia also announced that the company was awarded its California Medical Device Manufacturing license, allowing manufacturing operations to formally commence at its new facility in Redwood City, Calif.

• NIDEK launched the Fully Assisted Refraction System (FARS), an optional kit for the TS-610 NIDEK Tabletop Refraction System for performing subjective refractions that integrates the chart and refractor into a single unit. FARS is used to determine the full refractive correction based on patient response using objective data or spectacle prescription as the starting point. The kit consists of a joystick controller and the FARS application software. A Windows computer/tablet displays the test progress and times as the refraction progresses. A staff member can check progress even if they do not accompany the patient.

• NovaSight will launch CureSight, a digital therapy for amblyopia (lazy eye), in the United States beginning this month. CureSight received FDA 510(K) clearance based on a pivotal study that found the device to be non-inferior to eye patching for amblyopia treatment in children. CureSight therapy is carried out while the child watches any streamed content of their choice on a user-friendly, eye tracking-based device from their home. Treatment reports are shared via a web portal allowing eye-care providers to monitor patient treatment progress and compliance.

• Azura Ophthalmics announced positive 3-month efficacy and safety results from its Phase 2b study of AZR-MD-001 0.5% in meibomian gland dysfunction. AZR-MD-001 0.5% achieved statistically significant differences compared to vehicle in both signs and symptoms at month 3. The co-primary endpoint was achieved with significant improvements in the Meibomian Glands Yielding Liquid Secretion score, with patients experiencing an average increase of 1.8 more open glands secreting meibum from baseline (p = 0.0004), and significant improvements in Ocular Surface Disease Index score, with patients reporting an average improvement of 3.5 from baseline (p = 0.0438). For more, see the study results here. 

• Parexel, a clinical research organization providing the full range of Phase 1 to 4 clinical development services, announced a formal agreement with MyEyeDr., a vision health-care organization, to refer its patients into existing and future ophthalmology clinical trials. Parexel and MyEyeDr. are collaborating on recruitment for a diabetic retinopathy clinical trial with future plans to expand into additional therapeutic areas such as endocrinology. Parexel and MyEyeDr. will partner on recruitment of patients for a wide variety of ophthalmology indications, including macular degeneration. Under the agreement, MyEyeDr. will be part of Parexel’s Community Alliance Network. 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.