NDA submitted for new, topical dry eye disease treatment

Aldeyra Therapeutics submitted an NDA to the FDA for topical reproxalap for treatment of signs and symptoms of dry eye disease. The submission is supported by five clinical trials, which include data showing that the drug’s activity can begin within minutes and last for up to 12 weeks of treatment. According to the company’s press release, more than 2,000 patients have been included in the studies with no significant safety concerns beyond mild, transient instillation site irritation in some cases. If approved, the company stated that this would be the first reactive aldehyde species modulator. The company’s press release also noted that reproxalap is in Phase 3 clinical trials for allergic conjunctivitis; results are expected in 2023.

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IND submitted for persistent corneal epithelial defect treatment

Kala Pharmaceuticals announced that it submitted an investigational new drug (IND) application to the FDA for KPI-012 as a possible treatment for persistent corneal epithelial defect. If accepted, Kala stated in a press release that it is on track to begin a Phase 2b clinical trial to evaluate the safety and efficacy of KPI-012 for this indication with results expected in 2024. KPI-012, according to the company, has a multifactorial mechanism of action. If this trial is positive, it would be the first of two pivotal trials to support a submission for a biologics license agreement.

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IND filed for dry eye disease treatment

OKYO Pharma filed an IND with the FDA for its development of OK-101 for treatment of dry eye disease. According to the company’s press release, the company is set to begin a Phase 2, first-in-human clinical trial with OK-101 in 2023. OK-101 is described as a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor. This receptor, the company continued, is typically found on immune cells that are responsible for inflammatory response in the eye. In animal studies, OK-101 showed anti-inflammatory and neuropathic pain-reducing activity, the press release stated.

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Study: Investigational topical drop reduces inflammation in anterior uveitis cases

Oculis announced publication of its Phase 2 data that found licaminlimab (OCS-02) reduced inflammation in patients with acute anterior uveitis. Licaminlimab is an anti-TNFα antibody, which is already approved for treatment of ocular diseases via systemic administration. According to the company’s press release, this compound has a dual mechanism of action—anti-inflammation and anti-necrosis. If approved, licaminlimab would be the first topical anti-TNFα that would be a “steroid-sparing agent” for the treatment of non-infectious anterior uveitis that also avoids systemic risks, according to the company.

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Alcon completes acquisition of Aerie

Alcon completed its acquisition of Aerie Pharmaceuticals. With this acquisition, Alcon now brings Rocklatan (netarsudil and latanoprost ophthalmic solution) and Rhopressa (netarsudil ophthalmic solution) into its product line, in addition to AR-15512, an investigational drug for dry eye disease in Phase 3 clinical trials.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, is open now!
• Annual Meeting submission opportunity: Three symposia at the ASCRS Annual Meeting are seeking video case submissions. Find more information here.
• Ophthalmology Quicksand Chronicles podcast: A new episode of this ASCRS podcast, featuring hosts Nicole Fram, MD, and Elizabeth Yeu, MD, and guest Kourtney Houser, MD, is online now (ASCRS login required).

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Research highlights

• A systematic review and Bayesian network meta-analysis published in the journal JAMA Ophthalmology sought to establish which IOLs are most effective for presbyopia correction. The analysis included 27 studies for a total of 2,605 patients and looked at studies that had trifocal, bifocal diffractive, extended depth of focus, accommodative, and monofocal IOLs. The researchers found that for near UCVA, trifocals and bifocal diffractive IOLs were the most effective; trifocal IOLs and EDOF IOLs were most effective for intermediate UCVA. The authors wrote that for distance UCVA, all multifocal IOLs were comparable to monofocal, and there was no statistical difference between multifocal and monofocal IOLs in contrast sensitivity, glare, or halo. The investigators concluded that “bilateral implantation of trifocal IOLs might be an optimal option” when presbyopia correction/mitigation is desired by the patient.
• The effect of pharmacologic pupil dilation on axial length measurements in patients with dense cataract who previously had low-quality axial length measurements without dilation was the subject of a retrospective case series published in the Journal of Cataract & Refractive Surgery. The paper included 2,076 patients who had SS-OCT, 177 of whom had low-quality measurements due to dense cataracts. Of these, 79 had repeat SS-OCT after pupil dilation with a pharmacologic agent. After pupil dilation, successful high-quality axial length measurements were obtained in 60 of the 79 patients. The authors wrote that the mean standard deviation of the axial length measurements decreased significantly, and the number of successful scans increased significantly after pupil dilation. The authors concluded that with pharmacological pupil dilation improving quality of measurements, the results “could potentially improve postoperative refractive outcomes … and reduce the need of additional [axial length] measurements by more complicated alternative means in [eyes with dense cataracts].”

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Product news

• Tafluprost ophthalmic solution was launched as a therapeutically equivalent generic to ZIOPTAN by Prasco Laboratories in partnership with Théa Pharma.

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