FDA approves biosimilar to treat wet AMD

Xbrane Biopharma received FDA approval for Lucamzi (ranibizumab-blrz) as a biosimilar to Lucentis for treatment of wet AMD and other ocular conditions. A commercial launch is expected in the U.S. in 2027.

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First patient dosed in Phase 1/2 study for infectious conjunctivitis

Okogen has dosed its first patient in a multicenter Phase 1/2 trial evaluating Treyegen (OKG-0303) as a possible treatment for infectious conjunctivitis. According to the company’s press release, Treyegen is composed of ranpirnase (an investigational antiviral), tobramycin, and oxymetazoline. The company noted there are no FDA approved anti-viral therapies indicated for adenoviral conjunctivitis, one of the most common causes of infectious conjunctivitis.

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First patient dosed in Phase 3 trial for investigational retinitis pigmentosa treatment

Nacuity Pharmaceuticals has dosed the first patient in its Phase 3 study evaluating NPI-001 for treatment of retinitis pigmentosa associated with Usher syndrome. The trial is enrolling up to 80 adult participants who will self-administer oral NPI-001—a formulation of N-acetylcysteine amide—or placebo to evaluate whether the treatment reduces photoreceptor loss.

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Orphan Drug Designation granted to investigational retinitis pigmentosa therapy

Octant has received an FDA Orphan Drug Designation for OCT-980, an oral, small molecule for treatment of retinitis pigmentosa. According to the company’s press release, OCT-980 is designed to correct protein misfolding that occurs in rhodopsin-associated autosomal dominant retinitis pigmentosa. The cell therapy is currently in a Phase 1/2 clinical study.

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CMS releases MPFS and ASC final rules

On November 4, the Centers for Medicare & Medicaid Services (CMS) released both the Calendar Year (CY) 2027 Medicare Physician Fee Schedule (MPFS) final rule and the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Policy Changes and Payment Rates final rule.

Physician Fee Schedule
As required by the MACRA statute, there are two separate conversion factors: one for qualifying alternative payment model (APM) participants, and one for physicians and practitioners who are not QPs. The update to the qualifying APM conversion factor for CY27 is +0.75%, and the update to the non-qualifying APM conversion factor for CY27 is +0.25%. In addition to these updates, the conversion factor also includes a –0.12% budget neutrality adjustment. However, Public Law 119-21, which CMS refers to as the Working Families Tax Cut (WFTC) legislation, provided a 1-year conversion factor increase of 2.5% for CY 2026, which will no longer be in effect for CY 2027. Therefore, this requires a 2.5% reduction in the conversion factor for 2027.

• CY27 qualifying APM conversion factor: $32.95 (down 1.83% from 2026)
• CY27 non-qualifying conversion factor: $32.63 (down 2.31% from 2026)

For ophthalmology, the estimated CY27 combined impact on total allowed charges from all changes is –3%.

The final CY27 Medicare payment for 66984 is $442.12, which represents a 4% reduction from 2026.

• Modifier -25: CMS scaled back its proposed cut for same-day E/M visits. It applies only to 0-day global procedures, not to 10- and 90-day globals as proposed. The higher-paid service will be paid at 100% and the other same-day services at 80%, instead of the proposed 50%.
• Practice expense: CMS finalized removal of the indirect practice cost index (IPCI). It will be phased out over 2 years and replaced with a stabilizer that limits annual changes to a service’s practice expense values to 5%. ASCRS estimates that once fully phased in, these changes will reduce practice expense RVUs for cataract surgery by 30% over 5–6 years.

ASC Payment System
The final ASC conversion factor is $57.721 for ASCs that meet quality reporting requirements and $56.592 for those that do not. Even with a 2.3% market basket update, CMS estimates ASC payments for eye and ocular adnexa procedures will fall 1%, and ASC payment for 66984 will fall about 2%.

Read the full ASCRS alerts on the MPFS final rule and ASC final rule.

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Company news

• Kiora Pharmaceuticals obtained the exclusive development and commercialization rights for KIO-401 outside Asia. KIO-401 is under investigation for treatment of central retinal artery occlusion.
• A new company, VisioSurgical Solutions, has launched and begun development of a surgical robot for retinal surgery.

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ASCRS news and events

• ASCRS Annual Meeting: Hotel rooms are available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location. Meeting registration opens later this month.
• ASCRS Foundation: Support the sight-restoring work of the ASCRS Foundation’s domestic charitable cataract surgery program, Operation Sight, by making a tax-deductible donation today.
• BRiCS Summit: BRiCS Summit, an initiative of ASCRS and ASOA, is back with a session at the upcoming OSN New York meeting on Sunday, November 8. If you’re attending this meeting, join moderators Nicole Fram, MD, and Matt Jensen, MBA, as they lead a panel of top surgeons and practice leaders discussing What’s in the Secret Sauce of a thriving refractive cataract practice. To attend this session, register for OSN New York taking place November 6–8 at the Sheraton Times Square Hotel in New York City.

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EyeWorld article of the week

U.S. ophthalmologists who have used the FDA-approved epithelium-on crosslinking system Epioxa (Glaukos) in the “real world” are excited to share their insights and perspectives on this new option that they think will be safer for patients, facilitate faster healing, and could potentially stop progression of keratoconus sooner. Read about it in this article.

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Research highlights

• A longitudinal retrospective study published in the Journal of Cataract & Refractive Surgery evaluated the long-term outcomes of intracorneal ring segments followed by epi-off accelerated crosslinking in patients with pediatric keratoconus. The study included 73 eyes. Overall, the authors reported that “significant improvements were observed in visual and keratometric outcomes compared with preoperative values.” More specifically, at 60 months, UDVA and CDVA improved by 0.29 logMAR and 0.15 logMAR, respectively. Mean keratometry decreased by 2.74 D in 60 months postop, and K2 decreased by 4.01 D at 84 months. There were also improvements that were sustained in refractive and corneal astigmatism. “These findings support its role as a comprehensive therapeutic approach to halt long-term disease progression and enhance visual function,” the authors wrote.
• The rates of severe vision loss (defined as a loss of ≥0.60 logMAR from preop to postop visual acuity) after cataract surgery was evaluated in a report published in the journal Eye. Using data from the Royal College of Ophthalmologists’ National Ophthalmology Database Cataract Audit from 2010 to 2024, severe vision loss occurred in 0.21% of cases (3,723 eyes). Three of these cases of severe vision loss (from two patients) occurred in the setting of immediate sequential bilateral cataract surgery; there were 2,718 cases in which ISBCS was performed. The authors reported that the highest rate of severe vision loss occurred when eyes were left aphakic (10.68%) or when there was posterior capsule rupture (3.32%). Severe vision loss rates were also higher if eyes had prior intravitreal injections, optic nerve or central nervous system problems, AMD, prior vitrectomy, diabetic retinopathy, glaucoma, or corneal pathology.

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Product news

• Harrow launched HarrowRx as a prescribing and access pharmacy platform that interfaces with electronic medical record systems. HarrowRx was created to streamline prescription of Harrow-branded products.
• Sun Pharma has been ordered by drug regulators to stop manufacturing, selling, and distributing ophthalmic products made at its facility in Assam, India, due to quality issues. The shutdown was ordered in August but was recently reported by Reuters.

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