Therapeutics

Glaukos Corp's iDose TR has received FDA approval for the reduction of IOP in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG) following a new drug application (NDA) submission.

According to the company, OCU410 is a modifier gene therapy product candidate being developed for dry AMD

Ophthalmology witnessed a transformative year with 12 FDA approvals. As the year concludes, there remains a robust pipeline of drugs, setting high expectations for continued advancements in ophthalmological care in 2024 and beyond.

TP-03 (lotilaner ophthalmic solution, 0.25%) was approved by the FDA in 2023 under the brand name Xdemvy for the treatment of Demodex blepharitis and s being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites.

This is just one of many times the FDA has issued a warning to companies for the sale of unapproved ophthalmic products in 2023.

ATSN-101, a gene therapy for GUCY2D-associated Leber congenital amaurosis, has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious adverse events 6 months post-treatment in ongoing Phase I/II clinical trial.

TRS01 has the potential to be the first-line treatment option for non-infectious uveitis and specifically uveitic glaucoma, according to the company.

According to the company, OCU410ST uses an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene.

Ophthalmologists should consider a few key points before writing a prescription.

Peter K. Kaiser, MD, shares a promising outlook for patients with dry age-related macular degeneration, with innovative therapies in development that have the potential not only to prevent vision loss but also improve visual acuity.

Analysis showed low-dose, preservative-free formulation of atropine is effective in slowing progression in children aged 3 to 17, living in the US and European Union.

Researchers conducted a study on 145 patients with night vision problems, testing the effects of 0.75% phentolamine ophthalmic solution. The trial demonstrated substantial improvement in visual acuity on both evaluation days.

The clinical trial will evaluate the safety and efficacy of CLS-AX (axitinib injectable suspension), a tyrosine kinase inhibitor. According to the company, topline data is expected during the third quarter of 2024.

By taking a proactive approach to treatment, ophthalmologists can identify the “silent sufferers.”

New drugs are now in the pipeline to focus on treatment of the disease.

Acanthamoeba keratitis can lead to inflammation of the cornea and result in extreme levels of pain, light sensitivity and vision loss.

BRIO-1 clinical trial sowing optimism as a potential therapeutic option.

Researchers have delved into the possibility of cell-based therapy in ophthalmology. By targeting vitreoretinal diseases, they are tackling a range of vision-threatening disorders which often result in severe irreversible vision loss.

The issuance provides patent protection in the U.S. for therapeutics incorporating the optimized ELOVL2 transgene until 2041. The patent is being prosecuted in the European Union and other countries around the globe. The company said the patent adds value to its lead program in dry AMD.

According to the company, the clinical trial will assess the safety, efficacy and tolerability of AURN001, a combination cell therapy product.

The FDA has granted temporary discretion to import erythromycin ophthalmic ointment for the treatment of newborns.

Orasis Pharmaceuticals announces approval of Qlosi, a preservative-free, low-dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials.

Orasis Pharmaceuticals CEO Elad Kedar and COO Paul Smith sat down with David Hutton to discuss the FDA approval of Qlosi, a preservative-free low-dose eyedrops for presbyopia.

The data was presented in a poster titled at the American Thyroid Association (ATA).

Ocuphire Pharma and Viatris developed the drug together for the reversal of pharmacologically-induced mydriasis (RM) produced by adrenergic agonist or parasympatholytic agents.

Preservative-free Iyuzeh, launched more than 10 years ago, currently is available in 46 countries, mostly under the brand name Monoprost, with about 1.5 million patients treated monthly, according to the company.

According to a news release, the J-code for SYFOVRE will become effective on October 1, 2023.

Sustained delivery strategy is offering hope for patients diagnosed with the disease.

Targeting the interleukin-11 receptor, LASN01 is a potential treatment for fibro-inflammatory diseases including thyroid eye disease (TED) and idiopathic pulmonary fibrosis (IPF).

TOUR006 is an anti-IL-6 antibody with a differentiated profile for the treatment of thyroid eye disease (TED).