Topline data from Phase 3 presbyopia drop trial

Visus Therapeutics, in sharing more topline data from its Phase 3 pivotal trial, announced that BRIMOCHOL PF met its prespecified FDA preliminary endpoint for binocular near visual acuity (the proportion of participants achieving a more than 15 ETDRS letter gain without a loss of 5 or more letters at distance at all time points through hour 6). It was well tolerated with no significant adverse events; no participants discontinued drop use due to adverse events, and headaches occurred in 10% of participants. According to the company’s press release, the investigational drop intended for temporary treatment of presbyopia achieved a statistically significant reduction in pupil size at all time points (30 minutes out to 10 hours), as well as a statistically significant improvement in distance vision at 8 hours. The company noted that these signs of efficacy were greater than the active controls in the trial. BRIMOCHOL PF is a carbachol/brimonidine tartrate fixed-dose combination that in the trial was compared to topical carbachol monotherapy and brimonidine tartrate monotherapy in participants who were either phakic or pseudophakic. Topline results from a second, ongoing Phase 3 trial are expected in the second half of 2023. The company plans to file an NDA with the FDA in the second half of 2024.

Back to top

Femtosecond laser for LASIK receives FDA clearance

The ELITA Femtosecond Laser (Johnson & Johnson Vision) received FDA 510(k) clearance for the indication of creating LASIK flaps. This device, according to the company, has low energy per pulse, an “ultra-fast” repetition rate, and small spot size, with the ability to create a smooth stromal bed for “effortless flap lifts.”

Back to top

Enrollment complete for hydrophobic trifocal IOL trial

BVI announced that it completed enrollment in its IDE study for a hydrophobic trifocal IOL (FINEVISION HP). According to the company’s press release, the IOL has been implanted in 539 patients for a prospective, multicenter, controlled study. As the study progresses, patients will be evaluated for safety and efficacy of the IOL with the results forming the basis for regulatory submission in the U.S.

Back to top

Early results from clinical trial for dry eye therapy

Palatin Technologies announced early results in an ARVO poster presentation for PL9643, an investigational treatment for signs and symptoms of moderate to severe dry eye disease. According to the data, improvement in signs and symptom endpoints was statistically significant. The company’s press release reports that PL9643 showed efficacy “across multiple clinical signs and reduced symptomatic ocular pain indicating that PL9643 is having a positive affect across multiple regions of the eye.” There were no adverse ocular events related to treatment from the analyses. Topline results are expected in the second half of 2023.

Back to top

FDA clears IND application for clinical trial of therapy for X-linked retinoschisis

The FDA cleared an IND application from Atsena Therapeutics for its Phase 1/2 trial of ATSN-201 for patients with X-linked retinoschisis. According to the company’s press release, this investigational therapy is delivered intravitreally through capsids that avoid some of the limitations associated with gene therapies that are delivered through AAVs. The company describes the Phase 1/2 study as an open-label, dose-escalation trial that will evaluate ATSN-201 in male patients with a diagnosis of XLRS caused by pathogenic or likely pathogenic mutations in RS1. There are currently no approved therapies for X-linked retinoschisis.

Back to top

Innovations in capsulotomy creation device

Centricity Vision announced innovations underway for its ZEPTO Precision Capsulotomy Platform for automated capsulotomy creation. According to the company’s press release, under development are the ZEPTOLINK platform and ZEPTO 5.5 mm capsulotomy technology. ZEPTOLINK is intended to integrate with any phacoemulsification system, while the 5.5 mm handpiece is being created for those who prefer a larger capsulotomy. Currently ZEPTO creates a 5.2 mm capsulotomy.

Back to top

Company acquisition news

Iveric Bio will be acquired by Astellas Pharma. The company announced the definitive agreement that will make Iveric Bio an indirectly wholly owned subsidiary of Astellas.

Back to top

ASCRS news and events

• ASCRS Annual Meeting: The ASCRS Annual Meeting begins today with ASCRS Subspecialty Day followed by the kickoff of the main program in San Diego, California.
• ASCRS Summer Meeting: The ASCRS Summer Meeting in Nashville, Tennessee, returns August 11–13. Mark your calendar. Registration is open now.
• New webinar: The latest YES Connect Webinar—Refractive Surgery 101: Pearls for Getting Started with LASIK/PRK/SMILE/ICL/RLE—is online now.

Back to top

Research highlights

• Visual outcomes and postop complications after phaco cataract surgery where there was a posterior capsule rupture and dropped lens fragments were compared to that of uneventful cataract surgery. This retrospective, comparative, non-randomized study was conducted at eight U.K. National Health Service Departments. The analysis included 175,589 eyes, 2,751 of which had a posterior capsule rupture and 519 had dropped lens fragments. According to the paper, which is published in the Journal of Cataract & Refractive Surgery, at all postop timepoints, the eyes in these two groups had significantly worse mean visual acuity compared to the eyes with uneventful surgery. More eyes in these groups also developed CME, and the odds of needing surgery for retinal detachment or for epiretinal membrane were higher as well.
• A paper published in the journal Clinical Ophthalmology sought to validate a novel technique to improve efficacy of crosslinking for post-LASIK ectasia. The retrospective, comparative study included two groups: Group 1 (n=22) received the novel technique of topography-guided PRK followed by customized PTK followed by crosslinking and Group 2 (n=10) received accelerated crosslinking. The authors reported that patients in Group 1 experienced significant improvements in most parameters and showed stability of their ectatic condition at the last postop visit (which was 17.2 months±10.2 months). Group 2 showed stability at the 2 and 3 month postop visits but one patient’s ectasia had progressed by the last follow-up visit. The authors concluded that the study validated the novel protocol.

Back to top

Product news

• Thea Pharmaceuticals issued a statement about Akorn Operating Company’s voluntary recall of certain products (Thea acquired a portfolio of ophthalmic products from Akorn in 2022), noting that none of the products it acquired from the company are impacted by the recall.
• Harrow announced that three FDA-approved ophthalmic medicines are now available through this company: ILEVRO (nepafenac ophthalmic suspension) 0.3%, NEVANAC (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX (dexamethasone ophthalmic suspension) 0.1%.

Back to top

---