Martin David Harp, Editor, Ophthalmology Times

Outlook Therapeutics seeks FDA clarity on ONS-5010 after a complete response letter, aiming to address efficacy concerns for wet AMD treatment.

Naureen Haroon, OD, MPH, FAAO, founder of the newly formed WHSIG, said the group's primary aim is to educate the optometric community about why certain eye conditions disproportionately affect women.

FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.

The acquisition focuses on LayerBio's OcuRing-K technology, with plans to initiate the next clinical trial.

TearCare is associated with greater health utility over time but also resulted in significant cost savings compared with CsA.

The planned acquisition of STAAR includes the EVO family of lenses (EVO ICL) for vision correction for patients with moderate to high myopia with or without astigmatism.

The solution missed the primary end point of the trial, which was complete resolution of debris after 6 weeks of twice-daily dosing.

A Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025, was assigned by the FDA.

LumiThera’s PBM is the only device that has demonstrated meaningful vision improvement compared with baseline for people living with early to intermediate dry AMD.

Aldeyra resubmits NDA for reproxalap, aiming to address FDA concerns and demonstrate efficacy in treating dry eye disease symptoms.

The generic formulation references Pred Forte, which is trademarked by Allergan.

According to the company, results showed “a meaningful clinical improvement in ocular surface health” and significance for both staining end points at day 15.

Alcon’s dry eye candidate acoltremon 0.003% is a first-in-class thermoreceptor agonist, which stimulates corneal sensory nerves to increase natural tear production to treat the signs and symptoms of dry eye disease.

Susvimo is the first and only FDA-approved, continuous delivery treatment shown to maintain vision in people with DR with just one refill every 9 months

NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop with a dual mechanism of action (nitric oxide and prostaglandin analogue).

At ARVO 2025, Mark Bullimore, MCOptom, PhD, emphasized the need for more accurate, condition-specific tools in evaluating myopic eye growth and treatment efficacy.

Hammond and his team focused on creating a reliable conversion factor between 2 widely used optical coherence tomography (OCT) systems—the TopCon Maestro2 and the ZEISS Cirrus 5000. Their work specifically looked at ganglion cell–inner plexiform layer and retinal nerve fiber layer thickness measurements, which are critical markers in glaucoma diagnosis and monitoring.

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up to 24 weeks across currently-approved indications.

A survey collected demographic data, ocular and medical history, and responses assessing knowledge of glaucoma and cataracts in the Qassim region of Saudi Arabia.

The supplemental BLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion and for broadening the dosing schedule to include every-4-week dosing across approved indications.

The announcement follows the decision to discontinue the COAST and ShORe trials in wet age-related macular degeneration after the COAST trial failed to meet its primary end point.

A Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, was set by the organization.

Pantheon Vision’s bioengineered corneal implant aims to tackle issues with the success rate of human donated tissue.

The company stated that the FDA noted at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye should be conducted.

The decision to discontinue the trials comes shortly after the announcement that COAST missed its primary endpoint.

Lab TRIACTIV is powered by “advanced cationic liposomal technology” for dry eye relief and targets all 3 layers of the tear film.

In light of trial results, the company is preparing for financial outcomes dependent on its Development Funding Agreement, warranting a reexamination of Opthea's future.

Urcosmod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune cells of the eye responsible for the inflammatory response.

ENCELTO is the first and only FDA-approved treatment for MacTel.