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Quick Notes: February 14, 2024

Meridian receives FDA approval for the MR Q family of lasers; Study shows Vyzulta’s safety, effectiveness at reducing IOP; and more.

Ophthalmology Management February 14, 2024

  • Meridian Medical received FDA approval for the MR Q family of lasers. The lasers include: MR Q, a fully integrated ND:YAG laser combined with a precision optics LED slit lamp with a magnification range from 6x up to 40x selectable in five fixed steps; MR Q SLT, an Nd:YAG laser combined with a selective laser trabeculoplasty photo-regenerator; and MR Q supine, an Nd:YAG laser designed to treat patients in supine position, featuring ergonomic 0-210° tiltable Haag-Streit binoculars to improve the surgeons’ comfort and visual quality. The FDA approval of the MR Q line comes after Meridian received FDA approval in September 2023 for the Merilas line of lasers. 

  • A new study demonstrates the safety and effectiveness of latanoprostene bunod ophthalmic solution (Vyzulta, Bausch + Lomb) to reduce IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Based on real-world evidence, the study shows that patients who switched from another IOP-lowering therapy to Vyzulta gained an additional ~25% reduction in IOP, a significant improvement for managing this disease. This real-world retrospective chart review was performed to determine if patients with mild-to-moderate OAG/OHT who switched their IOP-lowering treatment(s) directly to Vyzulta without a washout period (a population not specifically evaluated in clinical trials) would receive any therapeutic benefits. 

  • OKYO Pharma Limited announced the FDA cleared OK-101 as its first investigational new drug (IND) application for the treatment of neuropathic corneal pain (NCP). The initial IND submission to the FDA proposed an open-label design for the clinical trial. Based on positive feedback from the FDA, the Phase 2 study is now designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients. A total of 54 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary endpoint will be measured utilizing visual analog scale pain relief scores. These protocol changes will enable a statistically valid demonstration of a true drug effect of OK-101 on NCP symptoms. The trial is scheduled to begin in Q2 2024.

  • Sylentis, a wholly-owned subsidiary of PharmaMar, obtained the results of the Phase 3 SYL10111_V (tivanisiran) clinical trial for the treatment of dry eye disease associated with Sjögren’s Syndrome. The primary endpoint was to evaluate the efficacy (signs and symptoms) and was not met. The trial was a randomized, double-masked, placebo-controlled study conducted in more than 40 hospitals in the United States and eight in Spain involving 203 patients.

  • Adverum Biotechnologies announced preliminary safety and efficacy data from the ongoing LUNA Phase 2 trial of Ixo-vec in patients with wet AMD. Sixty patients with wet AMD were enrolled equally across two dose cohorts: 2E11 and 6E10 vg/eye. Both doses demonstrated maintenance of visual and anatomic outcomes and resulted in a reduction in annualized anti-VEGF injections and the percentage of patients remaining free of annualized injections, the company says. At 26 weeks, Ixo-vec demonstrated annualized reduction in anti-VEGF injection rates of 90% (n=19) at 6E10 and 94% (n=20) at 2E11. At 26 weeks, Ixo-vec demonstrated injection free rates of 68% (n=19) at 6E10 and 85% (n=20) at 2E11. Visual acuity and anatomic endpoints were maintained at both dose levels. For more, see the study results here. 

  • Beacon Therapeutics Holdings Limited announced 12-month interim safety and efficacy results for the Phase 2 SKYLINE trial in patients with X-linked retinitis pigmentosa (XLRP). Data from males with XLRP demonstrated a response rate (defined as an improvement in retinal sensitivity, as assessed by microperimetry, of at least 7 decibels in at least 5 loci) of 63% in study eyes treated with a high dose (6.8 E+11 vg/eye) of AGTC-501. Response rates in study eyes treated with a low dose (7.5 E+10 vg/eye) of AGTC-501 were similar to the untreated fellow eyes in the high dose cohort (0% for both). In addition, patients in the high dose cohort also demonstrated a robust improvement in visual function, including mean retinal sensitivity. AGTC-501 was well-tolerated, and there were no clinically significant safety events associated with treatment. Any treatment-related adverse events were mostly nonserious and mild to moderate in severity, the company says. 

  • A study published in Thyroid examining audiometry outcomes following Tepezza (teprotumumab, Amgen) for thyroid eye disease found that long-term hearing loss is rare in those with normal audiometry at baseline following treatment with Tepezza. The study found that patients with normal range baseline audiometry on the whole maintained their hearing, while in some cases there was an effect or loss only in patients who presented with abnormal audiometry at baseline. Audiometry testing protocols by trained technicians were completed at baseline and prior to every infusion followed by 3-months and 6-months after completion. Mean thresholds at each frequency per visit, per ear, were evaluated by an independent audiologist and concluded that hearing losses in normal patients are considered highly unlikely and very rare. The published study comes on the heels of the FDA label warning update for Tepezza to include the potential of hearing loss. For more, see the study results here.

  • Eyebiotech Limited announced the presentation of Week 12 data from its first-in-human Phase 1b/2a AMARONE trial of Restoret in patients with treatment-naïve diabetic macular edema (DME) and treatment-naïve neovascular AMD (NVAMD). The data showed that Restoret was well-tolerated, with no drug-related adverse events, drug-related serious adverse events or intraocular inflammation reported. Patients with DME (n=26) received Restoret as monotherapy, manifesting a mean improvement in BCVA of +11.2 letters and a mean reduction in retinal thickness of -143 microns as measured by optical coherence tomography. Similar outcomes were observed in patients with NVAMD (n=5), who received Restoret in combination with aflibercept. Multiple monthly doses of Restoret, as both monotherapy and in combination with aflibercept, were well-tolerated.

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.