Pipeline

Paul Hahn, MD, PhD, shared insights on research comparing the relative efficacy of pegcetacoplan versus avacincaptad pegol in patients with geographic atrophy presented at the 2023 ASRS annual meeting.

According to the company, the therapeutic is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two phase 3 clinical trials.

Opthea’s lead biologic drug candidate OPT-302, which is under investigation for the treatment of wet AMD, received nonproprietary drug name sozinibercept, which is a critical step in the FDA approval process.

According to Tarsus Pharmaceuticals, lotilaner ophthalmic solution 0.25% is the first approved therapeutic for Demodex blepharitis, and has demonstrated efficacy across multiple clinical measures of disease.

The financing will help advance the company’s novel treatment system for glaucoma and other chronic ophthalmic diseases.

The product line will be acquired for $106.5 million, and will add another half dozen products to the company’s over-the-counter eye care product portfolio.

The company announced the Complete Letter Response from the FDA for the Biologics License Application for aflibercept 8 mg is “solely due to an ongoing review of inspection findings at a third-party filler."

Ahmad M. Fahmy, OD, FAAO, Dipl ABO, gives highlights of his AOA 2023 poster that was a pooled analysis of the Gobi and Mojave studies relevant to perfluorohexyloctane (NOV03) for dry eye disease associated with Meibomian gland dysfunction.

Over the past decade the progress in retinal disease treatments has exploded with increased numbers of approved pharmaceutical compounds, resulting in more options for treating retinal disease with intravitreal agents and more are in the pipeline.

NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17.

The two companies have announced an exclusive agreement for Polifarma to commercialize AVT06, the proposed biosimilar to Eylea, in Turkey.

This single-ingredient tear stabilizer from Bausch + Lomb and Novaliq could become the choice therapeutic for dry eye disease.

MIEBO, previously known as NOV03, is the first and only FDA-approved treatment for dry eye disease that targets tear evaporation.

Mydcombi is the first FDA-approved, fixed-combination of tropicamide and phenylephrine for the reversal of mydriasis.

The iDose TR, a micro-invasive intraocular implant designed to lower IOP in patients with open-angle glaucoma or ocular hypertension, has a PDUFA date of December 22, 2023.

According to the company, clinical trials of the ophthalmic gel showed that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure. Harrow will host several launch events at the 2023 American Society of Cataract and Refractive Surgery annual meeting being held May 5-8, 2023, in San Diego, California.

Eyecelerator kicks off today as the American Society of Cataract and Refractive Surgery will host this year’s ASCRS and ASOA Annual Meeting in San Diego, California, beginning on Friday. ViaLase Inc., Aurion Biotech among companies presenting at the annual meeting.

Data on Palatin’s formulation PL9643 indicates clinical efficacy across multiple signs and symptoms of dry eye disease without sacrificing safety and tolerability.

The medical technology company ViaLase will reveal the 2-year data from their FLigHT clinical study as well as give additional information about their pipeline at ASCRS 2023.

Euin Cheong, OD, weighs in on the Syfvore approval for geographic atrophy and how optometrists should participate in geographic atrophy care.

Allergan developed VUITY, which it noted is the first and only FDA-approved eye drop to treat presbyopia. The FDA has now approved a two-dose option.

Following the enrollment completion for Brimochol PF, topline Phase 3 data for the presbyopia candidate is expected in Q2 2023.

In Atlanta, Georgia, the OIS @ SECO Innovation Showcase highlighted the best and the brightest optometric and ophthalmic drugs, therapies, and tech we hope to see come to fruition.

Paul Smith shares an update on Orasis Pharmaceutical's CSF-1 drug and what to expect this year.

BRIM Biotechnology’s BRM421 is a first-in-class regenerative peptide and could relieve signs and symptoms of dry eye disease in as little as 2 weeks.

The Biologics License Application for aflibercept 8 mg was supported by positive data from the PULSAR study, investigating wet AMD, and the PHOTON study, investigating DME.

A PDUFA goal date of October 22, 2023 was assigned to the investigational eye drop candidate for the treatment of presbyopia.

Following the submission of the 24-month phase 3 data in November 2022, Apellis received FDA approval for intravitreal pegcetacoplan (SYFOVRE) to treat geographic atrophy secondary to AMD.