• Ocuphire Pharma announced the submission of a new drug application (NDA) to the FDA for phentolamine ophthalmic solution 0.75% (Nyxol) for the reversal of pharmacologically induced mydriasis (RM) produced by adrenergic agonist (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents, or a combination thereof. The NDA is supported by positive results from the comprehensive MIRA clinical program collectively involving over 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials,and MIRA-4 Phase 3 pediatric trial. The MIRA-2 and MIRA-3 trials successfully met their primary and key secondary endpoints, demonstrating statistically significant superiority of Nyxol compared to placebo to rapidly return dilated eyes to their baseline pupil diameter as early as 60 and 90 minutes. The positive MIRA-4 pediatric trial results support a potential broader label for Nyxol in RM to include pediatric subjects aged 3 and older.

• Lumibird Medical launched the next generation YAG/SLT laser, the Tango Reflex Neo, by Ellex. A fully integrated Q-switched Nd:YAG and frequency doubled Nd:YAG laser for anterior-segment YAG and glaucoma indications, Tango Reflex Neo features second-generation Reflex technology with True Coaxial Illumination, enhancing visualization of anterior and posterior segments. Features include Imprint, a dynamic heads-up display with real-time view of treatment settings within the binoculars, joystick control of energy settings and up to 2 mm YAG posterior offset, facilitating Premium Refractive Outcome Capsulotomies (PROcap), an alternative approach to Nd:YAG Posterior Capsulotomy. PROcap was developed to improve the geometry of capsule openings, maximize IOL protection and reduce postoperative iatrogenic floaters. 

• Visiox Pharma received notification from the FDA that the agency has completed its filing review and accepted for filing the NDA for PDP-716 (0.35% brimonidine tartrate). PDP-716 is a novel once-daily brimonidine formulation for ocular hypertension and open-angle glaucoma, that utilizes the company's patented TearAct fine resin delivery technology, which provides slow, consistent and sustained release for IOP control throughout the day. The FDA has assigned a Prescription Drug User Fee Act target action date of Aug. 4, 2023.

• CORD LLC submitted a premarket approval application to the FDA for the Model SC9 IOL for the treatment of cataracts. The SC9 lens was designed to treat cataract patients with a single focus spherical optic and a rigid structure to consistently locate the optic in a position intended to provide intermediate vision. CORD is seeking market approval of the SC9 based on the results of more than 300 patients who were followed for a minimum of one year under an approved Investigational Device Exemption.

• Lineage Cell Therapeutics announced that its partner Genentech launched a Phase 2a, multicenter, open-label, single-arm clinical study of RG6501 (OpRegen), a retinal pigment epithelial cell therapy. The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy secondary to AMD. The primary objectives of the study are to evaluate the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina and to evaluate the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. OpRegen is being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.

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