510(k) clearance granted to auto kerato-refracto tonometer

Topcon Healthcare announced that FDA 510(k) clearance was granted to OMNIA, described by the company as a 4-in-1 pretesting solution that obtains refraction, keratometry, tonometry, and pachymetry with a single device. With this clearance, the company has begun its commercial launch of the device, which it stated in a press release “enhances workflow, shortens training time, and provides reliable data even when operated by new users.” According to the press release, the device captures 20 data points in less than 1 minute.

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First patient dosed with gene therapy for Best disease

Opus Genetics has dosed its first patient in a Phase 1/2 trial for a gene therapy targeting Best disease. According to the company’s press release, Best disease causes vitelliform macular dystrophy, a rare, inherited condition resulting from mutations in the BEST1 gene. The gene therapy, OPGx-BEST1, is administered in a subretinal injection with the hope of restoring function to the retinal pigment epithelium. This ongoing multicenter, adaptive, open-label, dose-exploring study will evaluate safety, tolerability, and efficacy of the gene therapy. Initial trial data is expected within the first quarter of 2026.

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Long-term data shows therapy delays geographic atrophy progression

Apellis Pharmaceuticals announced post-hoc analysis from an extension study that included 5 years of continuous treatment of SYFOVRE (pegcetacoplan injection) for geographic atrophy secondary to AMD. According to the company’s press release, every other month dosing and monthly dosing delayed geographic atrophy lesion growth by about 1.5 years in patients with nonsubfoveal geographic atrophy, compared to sham controls. The safety profile of SYFOVRE was consistent with previously reported data.

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Lead gene therapy candidate to treat wet AMD and DME announced

Coave Therapeutics announced its lead gene therapy program for the treatment of retinal vascular diseases like wet AMD and diabetic macular edema. CoTx-101 is delivered via a “first-in-class proprietary suprachoroidal vector.” In animal studies, the vector “demonstrated unprecedented transduction efficacy of RPE and photoreceptors,” according to the company’s press release.

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FDA accepts BLA resubmission

Outlook Therapeutics resubmitted a Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), which was accepted by the FDA. According to the company’s press release, the FDA has set a new PDUFA goal date of December 31, 2025. If approved, the treatment for wet AMD would be branded as LYTENAVA.

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Company news

• Harrow completed its acquisition of Melt Pharmaceuticals, which includes its product candidates MELT-210, MELT-300, and MELT-400, all based on a proprietary, oral dissolving tablet drug delivery platform. MELT-300, according to the company’s press release is designed to deliver a sublingual, fixed dose of midazolam (3 mg) and ketamine (50 mg) for sedation. Harrow plans to have an NDA submission for MELT-300 prepared for the FDA in the first half of 2027 with the potential for approval in the first half of 2028.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13, 2026. Get involved with the meeting by submitting a case video—learn more.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.

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Research highlights

• A non-inferiority randomized clinical trial evaluated whether creating a capsulorhexis based on a manual marking system (using a lens caliper) was non-inferior to a capsulorhexis created with a digital guidance system. According to the paper published in JAMA Ophthalmology, the lens caliper was used in the manual marking group to mark with its blunt head the anterior lens capsule to guide the capsulotomy location. The digitally guided group had a ring with target diameter projected onto the eye to guide capsulorhexis creation. The main outcome was mean deviation of capsulorhexis diameter from the target diameter, with non-inferiority being within a margin of 0.2 mm. Secondary outcomes were “ratio of ideal capsulorhexis, grades of capsulorhexis–intraocular lens (IOL) overlap, off-center distance of capsulorhexis, postoperative best-corrected visual acuity, IOL tilt, and decentration.” Overall, the investigators found that manual marking was non-inferior to digital guidance. “Since the [manual marking-assisted capsulorhexis] technique does not require special equipment, it might be considered routinely in clinical practice settings if similar outcomes are obtained elsewhere,” the authors concluded.
• The 6-month efficacy and safety results of the Ophtec Artiplus multifocal iris-fixated phakic IOL were published in the Journal of Cataract & Refractive Surgery. The multicenter study took place at seven sites as a non-randomized prospective clinical trial. Patients (n=49, 98 eyes) received bilateral implantation of the Artiplus IOL. At 6 months, the authors reported mean binocular uncorrected distance, intermediate, and near visual acuity to be −0.05±0.09 logMAR, −0.02±0.07 logMAR, and 0.02±0.08 logMAR, respectively. Ninety-five percent of eyes were within ±1.0 D of target mean spherical equivalent and 77% were within ±0.5 D. The authors reported the binocular distance-corrected defocus curve was a “visual acuity of 0.20 logMAR or better over a range of +1.0 to −3.5 D.” Patients gave their experience with the lens a 3.5 on a 4-point scale, with 83% reporting spectacle independence. From an aberrations standpoint, patients reported experiencing “well tolerated” glare, halo, and starbursts at 47%, 35%, and 96%, respectively. The investigators noted that “only 2% of patients found halos and starbursts to be very bothersome.”

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Product news

• Orasis Pharmaceuticals is offering eyecare providers Starter Packs of Qlosi (pilocarpine hydrochloride ophthalmic solution, 0.4%) to increase access for patients seeking temporary correction of presbyopia symptoms. According to the company’s press release, since its launch in 2025, Qlosi is currently available by prescription and “refill rates have exceeded expectations.” There have been “no serious adverse events reported since launch.”
• Cellution Biologics introduced its AmnioPlast 1, a dehydrated monolayered human amnion membrane allograft, and AmnioPlast Double, a dehydrated, dual-layer amnion membrane allograft, both of which are intended to be applied to the ocular surface following repair or reconstruction procedures.

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