NDA submitted to the FDA for presbyopia drop

Tenpoint Therapeutics announced submission of a New Drug Application (NDA) to the FDA for BRIMOCHOL PF for treatment of presbyopia. According to the company’s press release, this product, if approved, would be the “first fixed-dose combination therapy from the world’s largest and longest study ever conducted in the presbyopia eye drop category.” BRIMOCHOL is a combination of brimonidine and carbachol.

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FDA issues complete response letter to dry eye NDA

Aldeyra Therapeutics announced that the FDA issued a complete response letter to the company’s resubmission of a New Drug Application for reproxalap. In the letter, the FDA stated that reproxalap “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes,” advising “at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” be completed. The company’s press release regarding the response noted FDA concerns with the data from the trial that could affect interpretation of the results. The letter did not find any manufacturing or safety issues with reproxalap, according to the company. Aldeyra expects to have a Type A meeting with the FDA to discuss the complete response letter and ongoing clinical trials of reproxalap for dry eye.

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FDA accepts BLA resubmission for bevacizumab to treat wet AMD

Outlook Therapeutics announced that the FDA accepted its Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational treatment for wet AMD. According to the company’s press release, the BLA is a Class 2 review, and the FDA set a PDUFA goal date of August 27. If approved, the company noted it would be branded as LYTENAVA in the U.S. and would likely have 12 years of regulatory exclusivity.

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One-month results in Phase 1/2 trial for treating Leber congenital amaurosis in a pediatric patient

Opus Genetics announced early, positive results from its Phase 1/2 open-label trial evaluating OPGx-LCA5 for LCA5-related inherited retinal disease in a pediatric patient. According to the company’s press release, the first pediatric patient dosed in the ongoing trial (age 16 when entered) has shown consistent improvements since the single gene-therapy injection, like that of previous adult patients treated in the same study. More specifically, a trial investigator said this patient expressed that “objects were significantly brighter” and that the patient was able to “distinguish letters and navigate with independence she had never had before.” According to the company, this trial is enrolling three pediatric patients.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California. Find the most up-to-date information on the Real-Time Program here.
• SightLine at ASCRS: This is a new day-long meeting April 24, ahead of the ASCRS Annual Meeting, for all commercial stakeholders in ophthalmology to learn about and collaborate on technologies and care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 24 from 1:00–5:30 p.m. in Los Angeles ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Tune in each week for a new video.

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Research highlights

• Endothelial cell loss occurring after different manual small-incision cataract surgery (MSICS) techniques were compared in a prospective, single-blind, randomized controlled trial published in the Journal of Cataract & Refractive Surgery. Methods of MSICS nucleus delivery investigated in the study included viscoexpression, irrigating vectis, and phacosandwich. Patients included in the study were 40 years or older with immature cataract and no systemic or ocular comorbidities that could influence corneal epithelium. Patients whose surgeries had an intraoperative complication, who experienced postop corneal haze, and/or whose pupil dilated to less than 5 mm were excluded. Thirty patients were randomized to each group. The investigators found 12.12% endothelial cell loss after MSICS overall (10.81% in the viscoexpression group, 11.3% in the irrigating vectis group, and 14.28% in the phacosandwich group). Ultimately, statistical analysis determined that the endothelial cell loss in viscoexpression and irrigating vectis techniques were comparable and significantly less than that in the phacosandwich group.
• The efficacy of epithelium-off vs. transepithelial accelerated crosslinking in younger patients with keratoconus was compared in a prospective observational study published in the journal Eye. Sixty patients (age 16–26) were evenly assigned to an epithelium-off accelerated crosslinking group or the transepithelial group. At 12 months postop, there was a statistically significant difference between the groups in terms of central corneal thickness as measured by IOLMaster (Carl Zeiss Meditec), thinnest point of corneal thickness, overall thickness, corneal thickness as measured on OCT, deformation amplitude, first applanation time, first applanation velocity, second applanation time, second applanation velocity, peak distance, high contrast acuity, stiffness parameter at first applanation, and comprehensive refraction. The authors reported that the transepithelial procedure was “slightly inferior to the epithelium-off ACXL in maximum corneal curvature but superior in improving corneal thickness and DA parameters.”

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Product news

• Qlosi (pilocarpine hydrochloride ophthalmic solution, 0.4%, Orasis Pharmaceuticals) is now available to prescribe in the U.S. for up to 8 hours of presbyopia correction.

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