• The FDA approved Glaukos Corp.’s new drug application for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of IOP in patients with ocular hypertension or open-angle glaucoma. iDose TR is a long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is intended to address the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications. Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of the first quarter of 2024 and has established a wholesale acquisition cost for iDose TR of $13,950, per dose (or implant). In addition, Glaukos also introduced the iDose Your Dose Initiative. For every iDoseTR sold, Glaukos pledges to make available an equal number of iDoseTR units for qualifying charitable donation requests in the United States and around the globe for recipients that satisfy independent eligibility requirements.

• Carl Zeiss Meditec AG entered into an agreement to acquire 100% of the shares in Dutch Ophthalmic Research Center (International) B.V. (D.O.R.C.) from the investment firm Eurazeo SE, Paris. ZEISS says the acquisition will enhance and complement its ophthalmic portfolio and range of digitally connected workflow solutions for addressing a wide variety of eye conditions, including retinal disorders, cataracts, glaucoma and refractive errors. With the acquisition, ZEISS will expand its position in the vitreo-retinal (VR) surgery segment. D.O.R.C. also brings to the acquisition the EVA NEXUSTM platform, the core of a portfolio that comprises a dual-capable system and a full range of accessories, instruments and liquids offering a solution across VR, cataract, and combined procedures, providing a single platform for a variety of procedure types. The acquisition is expected to close in the first half of calendar year 2024. 

• Reichert Technologies, a business of AMETEK Inc., announced an exclusive partnership with SBM Sistemi of Italy to distribute SBM’s imaging and dry eye assessment and treatment devices in the United States. The Reichert-SBM IDRA is a complete system for supporting dry eye diagnosis. IDRA evaluates all the tear film layers (lipid, aqueous and mucin) and the meibomian glands to identify specific type of dye eye disease (DED) and provide personalized treatment recommendations relative to the patient’s needs. The IDRA and OS1000 ocular surface evaluation devices were designed for quick, painless and non-invasive assessment of DED. The Reichert-SBM OS1000 is an integrated diagnostic platform that combines a corneal topographer with DED assessment. The Reichert-SBM DEM100-DSLC200 is an anterior imaging camera system compatible with a wide range of slit lamps and is available with comprehensive DED assessment. The Reichert-SBM ACTIVA, is a non-invasive device that relieves symptoms caused by meibomian gland disfunction and associated evaporative dry eye.

• Clearside Biomedical completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in wet AMD. CLS-AX is a highly potent tyrosine kinase inhibitor delivered suprachoroidally using Clearside’s SCS Microinjector. The study is designed to evaluate at least 60 participants randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX is administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept is administered via intravitreal injection. The primary outcome measure is the mean change from baseline in BCVA. Secondary outcome measures include other changes from baseline in visual function and ocular anatomy, the need for supplemental treatment and treatment burden as measured by total injections over trial duration. Topline data results are expected in the third quarter of 2024.

• Amring Pharmaceuticals, a subsidiary of Nordic Group B.V. (Nordic Pharma), announced the completion of its acquisition of Visant Medical. This acquisition unites Nordic Pharma's experience in pharmaceuticals with Visant's FDA-cleared hyaluronic acid derivative LACRIFILL canalicular occlusive device, which is intended to temporarily block tear drainage by the occlusion of the canalicular system. Nordic Pharma will launch and commercialize LACRIFILL in the United States. This acquisition will enhance Nordic Pharma’s impact on the global ophthalmology market starting with the US launch of LACRIFILL, the patented therapy for DED. This is the second branded medical device Nordic Pharma will introduce in the United States. LACRIFILL received FDA 510(k) clearance and has an established CPT reimbursement code. 

• Nicox SA announced the first patient has been screened in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in IOP lowering. NCX 470, a novel nitric oxide (NO)-donating bimatoprost eyedrop, is the company’s lead product candidate in Phase 3 clinical development for IOP lowering in patients with open-angle glaucoma or ocular hypertension. The Whistler Phase 3b trial will enroll ~20 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study, which will investigate the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure. Each subject will participate in the trial for ~8 days and will provide insight into the mechanism of action of NCX 470. The trial is expected to take approximately 1 year to complete. 

• Oculis Holding announced First Patient First Visit in Stage 2 of its Phase 3 DIAMOND-1 trial evaluating Oculis’ lead product candidate OCS-01 for the treatment of diabetic macular edema (DME). DIAMOND-1 is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eyedrops in DME patients. The primary objective of the 3-month Stage 1 was to select the optimal dosing regimen (n=148). OCS-01 achieved the primary endpoint with robust statistical significance showing improvement in BCVA vs vehicle at Week 6 following the induction phase (OCS-01: 7.2 letters vs vehicle: 3.1 letters, p=0.007). The effect was sustained to Week 12 with the maintenance dose. Furthermore, 27.4% of patients in the OCS-01 group achieved ≥15-letter improvement in BCVA from baseline vs 7.5% in the vehicle group at Week 12 (p=0.009). A statistically significant decrease in Central Subfield Thickness was also observed. To learn more about the trial, click here.

• Azura Ophthalmics announced positive topline efficacy and safety results from a Phase 2 study of AZR-MD-001 in patients with contact lens discomfort who could not comfortably wear their lenses as desired and who demonstrated signs of meibomian gland dysfunction (MGD). The trial met its primary endpoint of showing a statistically significant improvement in Meibomian Glands Yielding Liquid Secretion (number of open glands). The study also met additional secondary and clinically meaningful endpoints, including significant improvements in meibum quality (measured by Meibomian Gland Score); tear stability (measured by tear break up time); ocular surface staining (measured by both fluorescein and lissamine green staining); and contact lens wear time. This is the second positive Phase 2 study of AZR-MD-001 to demonstrate statistically significant improvements across multiple sign and symptom endpoints in patients with MGD. For more, see the study results here.

• Ocugen Inc. announced the first patient has been dosed in the ArMaDa Phase 1/2 clinical trial of OCU410 (AAV-RORA), a modifier gene therapy product candidate being developed for dry AMD (dAMD). OCU410 is a potential curative therapy with a single sub-retinal injection that targets multiple pathways causing dAMD, including lipid metabolism, inflammation, oxidative stress and complement activation. This Phase 1/2 trial will assess the safety and efficacy of OCU410 for geographic atrophy secondary to dAMD and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study. Phase 2 is a randomized expansion phase in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 dose groups or to an untreated control group. 

• According to a report from Fortune Business Insights, “Intraocular Lens (IOL) Market, 2023-2030,” global IOL Market Size was valued at USD 4.24 billion in 2022 and is projected to grow USD 7.19 billion by 2030, exhibiting a CAGR of 6.9% during the forecast period. According to the report, the market is anticipated to experience growth due to a rise in cases of cataract and glaucoma. The expansion of market development is expected through increased support and favorable reimbursement policies. Additionally, the approval of new products, particularly those catering to extended depth of focus, is poised to further drive market development. For more from the report, click here.

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.