Alcon has made several announcements. The US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of dry eye disease (DED). Tryptyr is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. Also, Alcon launched the Unity Vitreoretinal Cataract System (VCS) and Unity Cataract System (CS). The platform offers 2 configurations, a combined console (VCS) as well as a standalone cataract system (CS). Finally, Alcon introduced the Clareon PanOptix Pro intraocular lens (IOL) for cataract patients.
Genentech annouced the FDA approved Susvimo (ranibizumab injection 100 mg/mL) for the treatment of diabetic retinopathy (DR), expanding the drug’s use beyond its current indications for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Susvimo is the first/only continuous delivery system approved for DR, requiring just 1 treatment every 9 months. Susvimo delivers a customized formulation of ranibizumab via a surgically implanted, refillable ocular device.
BVI Medical received 510(k) clearance from the FDA for its Laser Endoscopy Ophthalmic System (Leos) that is designed to lower intraocular pressure (IOP) through a minimally invasive ab interno procedure. The Leos system combines laser endoscopy with enhanced visualization capabilities and aims to improve glaucoma treatment at earlier stages of the disease and across a broad range of glaucoma types. A full US commercial launch of Leos is expected later this year, BVI said.
Luminopia, Inc. announced that the FDA cleared its amblyopia treatment for patients aged 8 to 12 years, expanding its existing label from patients 4 to 7 years old to patients 4 to <13 years old with amblyopia associated with anisometropia and/or mild strabismus. This marks the first FDA clearance for an amblyopia treatment for this age range in more than 2 decades, the company said. The FDA determined that Luminopia’s safety and efficacy in patients aged 8 to 12 years is substantially equivalent to its safety and efficacy in patients aged 4 to 7 years.
Amneal Pharmaceuticals announced the FDA approval of prednisolone acetate ophthalmic suspension, 1% sterile, which references Pred Forte. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation. According to the company, product launch is planned for Q3 of 2025.
Johnson & Johnson launched Acuvue Oasys Max 1-Day Multifocal for Astigmatism, the first and only daily disposable contact lens for people with both astigmatism and presbyopia, Johnson & Johnson said. According to the company, this contact lens provides patients crisp, clear, stable vision at all distances and in all lighting conditions, along with comfort that lasts all day. The lens is now available in the United States and Canada, and the launch of Acuvue Oasys Max 1-Day for Astigmatism is expected this summer.
Orasis Pharmaceuticals’ Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% novel, corrective prescription eye drop for the treatment of presbyopia in adults is now available to prescribe in the US. Patients have the flexibility of using 1 drop of Qlosi in each eye for improved near vision for a specific occasion or activity, and up to 2 drops per day for an extended effect, lasting up to 8 hours, the company said.
OcuSciences, Inc. announced the FDA granted marketing clearance for its OcuMet Beacon proprietary noninvasive tool for assessing retinal health. The ophthalmoscope device is indicated for infrared and autofluorescence imaging of the retina with or without the use of a mydriatic agent. The imager captures a naturally occurring fluorescence from the eye using proprietary illumination/detection technology, while software helps visualize the functional image signature.
Sight Sciences launched the Omni Edge Surgical System with TruSync technology that introduces a higher-capacity viscoelastic delivery feature (21 µL). Designed for versatility in minimally invasive glaucoma surgery (MIGS), Omni Edge reduces IOP by treating all 3 known areas of resistance in the aqueous outflow system—the trabecular meshwork, Schlemm’s canal, and the collector channels. The system is adaptable to all stages of primary open-angle glaucoma.
Bausch + Lomb launched Blink Nourish Lubricating eye drops and Blink Boost Lubricating eye drops. Both products are preservative-free, contact-lens friendly and formulated to provide hydration and comfort for dry eyes. Bausch + Lomb also launched Lumify Preservative Free redness reliever eye drops—preservative-free OTC eye drops with low-dose brimonidine tartrate 0.025%.
New World Medical launched its enhanced Streamline Surgical System, featuring a transparent tip designed to provide surgeons with improved visualization of anatomical structures throughout the procedure. The system also features ClickPulse Technology which provides controlled, targeted delivery of viscoelastic with up to 8 applications per procedure. The system is implant-free; seamlessly adapts into combined or standalone procedures; and features an ergonomic, single-use design for intuitive handling, safety, and control.
Peeq Pro announced the commercial release of its Peeq Waiva eyelid-cleaning device designed for everyday use. Built to target dry eyes, irritations, and eyelash mites, the Waiva provides a combination of gentle vibration, absorption, and a biodegradable, medical-grade sponge that cleans the eyelid area and helps reduce eyelid discomfort, the company said.
Tenpoint Therapeutics, Ltd. announced the FDA has accepted the new drug application (NDA) for Brimochol PF for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, for the drug. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application.
Aldeyra Therapeutics announced the resubmission of an NDA to the FDA for topical ocular reproxalap, an Investigational New Drug (IND) candidate, for the treatment of signs and symptoms of DED. Per FDA agreement, the only new clinical data included in the resubmitted NDA were from the recently completed dry eye chamber trial, which achieved the primary endpoint, the company said.
Ocugen, Inc. announced the FDA cleared the IND amendment to initiate a phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The trial will enroll 51 participants diagnosed with Stargardt disease. The primary objective is to evaluate the reduction in atrophic lesion size. Key secondary endpoints are improvements in BCVA and low-luminance visual acuity, compared to controls.
Selagine, Inc. announced that the FDA has granted IND clearance for immunoglobulin (IG) drops (GRF312 Ophthalmic Solution) for the treatment of patients with DED. An IG eye drop is an anti-inflammatory and immunomodulatory biologic drug generated from pooled human plasma from thousands of healthy donors.
Okyo Pharma Limited announced that the FDA has granted Fast Track designation to urcosimod for the treatment of neuropathic corneal pain (NCP), a debilitating condition characterized by persistent, severe eye pain caused by nerve damage. The Urcosimod phase 2 trial in NCP patients was designed as a double-masked, randomized, 12-week placebo-controlled trial with disease confirmed via confocal microscopy.
Harrow and Formosa Pharmaceuticals announced a licensing agreement whereby Harrow has acquired the exclusive US commercial rights for Byqlovi (clobetasol propionate ophthalmic suspension) 0.05%. Byqlovi was recently approved by the FDA for the treatment of postoperative inflammation and pain following ocular surgery. Harrow said it expects Byqlovi to be available in the fourth quarter of 2025.
AvKARE, a pharmaceutical distributor, released a voluntary drug recall notice that BRS Analytical Service, LLC is initiating a voluntary recall to the consumer level for several ophthalmic products. According to the notice, the recall has been initiated due to manufacturing cGMP deviations identified during an audit by the FDA. Visit https://tinyurl.com/5n76uek9 for more information.
Opus Genetics reported positive results from LYNX-2, its phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night-driving impairment in keratorefractive patients with reduced mesopic vision. The study met its primary endpoint of a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low-light conditions after 15 days of dosing.
Nicox SA reported the results of the Whistler phase 3b exploratory clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in IOP lowering in healthy volunteers and ocular hypertensive patients. Changes in aqueous humor flow rate trended towards significance vs placebo (p=0.072). Outflow facility was positive at 1 pm (p=0.081), significant at 3 pm (p=0.001), as was the diurnal outflow (p=0.004).
Iolyx Therapeutics reported data from its phase 2 trial of ILYX-002, a topical immunomodulator for moderate-to-severe DED associated with systemic autoimmune or inflammatory conditions. ILYX-002 produced a -1.41-point LS-mean advantage vs the vehicle control in total corneal fluorescein staining as early as day 15 (p = 0.0015), increasing to -1.78 points at day 57 (p = 0.0021). These results indicate a 36% to 44% improvement from baseline in the active arm vs 15% to 17% with vehicle control.