ASCRS advocacy helps protect MIGS coverage

Iridex and Sight Sciences issued press releases this week noting that five Medicare Administrative Contractors (MACs) withdrew their final local coverage determinations for MIGS, which had previously identified certain procedures for glaucoma management for possible changes to coverage. Thanks to advocacy efforts of ASCRS, the American Academy of Ophthalmology, the American Glaucoma Society, and the Outpatient Ophthalmic Surgery Society, which collaborated to provide feedback to the MACs, CMS, and Congress, Medicare coverage for procedures like cyclophotocoagulation and ab interno canaloplasty in combination with trabeculotomy will remain the same. Both companies noted the efforts by ASCRS as integral to the MACs’ decisions.

Back to top

FDA approves generic loteprednol etabonate ophthalmic suspension

Lupin announced FDA approval for its Abbreviated New Drug Application for loteprednol etabonate ophthalmic suspension. According to the company’s press release, this drug for temporary treatment of signs and symptoms of seasonal allergic conjunctivitis will be marketed as a generic equivalent to Alrex Ophthalmic Suspension (Bausch + Lomb).

Back to top

Orphan Drug Designation granted for corneal endothelial cell substitute

Cellusion received an Orphan Drug Designation from the FDA for its iPS cell-derived corneal endothelial cell substitute, CLS001, for treatment of bullous keratopathy. According to the company’s press release, CLS001 is “an alternative cell to corneal endothelial cells produced by efficiently differentiating iPS cells.” The company stated that it is advancing company-sponsored clinical trials in Japan and other global clinical trials for CLS001.

Back to top

Positive results in Phase 2 clinical trial for contact lens discomfort

Azura Ophthalmics announced positive results from its Phase 2 clinical trial evaluating AZR-MD-001 as a treatment for contact lens discomfort along with signs of meibomian gland dysfunction. According to the company’s press release, patients in the study who received AZR-MD-001, which is formulated as an ointment that includes selenium sulfide to soften keratin in blocked meibomian glands and to slow the production of keratin for increased meibum quality and quantity, gained at least 3 hours of comfortable contact lens wear and saw improvements in tear breakup time, meibum quality, and ocular surface staining. The investigational ointment was found safe and well tolerated, according to the press release. Azura is advancing AZR-MD-001 into a Phase 3 trial.

Back to top

First patient visits

In the last few weeks, first patient visits have taken place in several Phase 3 clinical trials.

• Oculis announced the first patient visit in its Phase 3 trial for OCS-01, a novel, high-concentration dexamethasone, for treatment of inflammation and pain following cataract surgery. The company expects a topline readout of the trial before the end of 2024.
• Oculis also announced the first patient visit in its Phase 3 trial for OCS-01 for treatment of diabetic macular edema.
• Stuart Therapeutics announced the first patient visit in its Phase 3 trial for ST-100 (vezocolmitide) for patients with dry eye disease.
• Nicox announced that the first patient was screened in its Phase 3b trial of NCX 470 for IOP lowering in open angle glaucoma and ocular hypertension. NCX 470 is a nitrox oxide-donating bimatoprost eye drop.

Back to top

Acquisition news

• Carl Zeiss Meditec announced that it entered into an agreement to acquire all shares of the Dutch Ophthalmic Research Center from Eurazeo SE. According to the company’s press release, this acquisition will “enhance and compliment Zeiss Medical Technology’s broad ophthalmic portfolio and range of digitally connected workflow solutions.” Further, the company stated that the acquisition would allow Zeiss to “expand its position in the vitreoretinal surgery segment.”
• MeiraGTx entered into an asset purchase agreement with Janssen Pharmaceuticals (a Johnson & Johnson company) for botaretigene sparoparvovec (bota-vec, previously AAV-RPGR) for the treatment of X-linked retinitis pigmentosa.
• Amring Pharmaceuticals, a subsidiary of Nordic Pharma Group, completed acquisition of Visant Medical, which produces the FDA-approved hyaluronic acid derivative LACRIFILL canalicular occlusive device.

Back to top

Complimentary access to video journal

The latest issue of the Video Journal of Cataract, Refractive, & Glaucoma Surgery, founded and edited by Robert Osher, MD, is online now.

Back to top

ASCRS news and events

• ASCRS Annual Meeting: Registration for the 2024 ASCRS Subspecialty Day and ASCRS Annual Meeting is open with tier 1, early bird pricing ending January 17. Learn more about this premier educational and networking event for anterior segment surgery here.
• ASCRS Podcast: Episode 6 of Ophthalmology Quicksand Chronicles—Eureka Moments! is available now. Find it here.
• ASCRS Grand Rounds: The latest installment of the Grand Rounds series, presented by Yale Department of Ophthalmology & Visual Sciences, is accessible here.

Back to top

Research highlights

• A prospective case series published in the Journal of Cataract & Refractive Surgery investigated the effect caused by YAG capsulotomies for PCO on toric rotation and cylinder power. The study included 41 eyes of 41 patients who had IOL position and power determined 1 month prior to YAG capsulotomy and 1 month after. According to the study, rotational misalignment was 4.65±2.75 degrees, on average, pre-YAG capsulotomy and 6.97±2.92 degrees post-YAG. Pre-YAG, cylinder power was 0.24±0.70 D; post-YAG it was 0.56±0.77 D. The study authors reported a significant decrease in IOL tilt (both in horizontal and vertical planes) after capsulotomy, but there was an increase in decentration. The investigators found these changes clinically insignificant but noted that it’s important to “consider that [toric IOL] misalignment may occur in patients undergoing early capsulotomy.”
• A cohort study including more than 3 million adults evaluated fall and fracture risk associated with cataract, AMD, and/or glaucoma. According to the research published in JAMA Ophthalmology, patients with these ocular conditions were matched to those without as comparators. The investigators saw an increased risk of falls during the study time period in patients who had cataract, glaucoma, or AMD compared to subjects who did not. Similarly, there was an increased risk for fractures among those with the eye diseases. The authors concluded that patients with one or more of these diseases “may benefit from improved advice, access, and referrals to falls prevention services.”

Back to top

Product news

• Reichert Technologies announced that it partnered with SBM Sistemi to distribute SBM’s imaging and dry eye assessment and treatment devices in the U.S.

Back to top

---