Eyeworld

SEPTEMBER 2021 | EYEWORLD | 59 R Contact Bafna: drbafna@clevelandeyeclinic.com Waring: gwaring@waringvision.com Dr. Bafna said the drops look promising overall. For patients who want a stop gap mea- sure between glasses or contacts and a surgical procedure, he thinks these drops are a good noninvasive methodology. Dr. Bafna highlighted the eye drops under investigation, primarily in clinical trials. Some of them are based on the concept of pupil con- striction, which increases the overall depth of field. The idea is that patients will only have to apply drops once or twice a day. Presbyopia eye drops in development AGN-190584 (Allergan): AGN-190584 (pilocarpine 1.25%) was tested in two Phase 3 clinical studies, GEMINI 1 and GEMINI 2, where the primary endpoint was met. According to the company, AGN- 190584 is "an investigational optimized formulation of pilocarpine, a cholinergic muscarinic receptor agonist, which activates muscarinic receptors located at smooth muscles such as the iris sphincter muscle and ciliary muscle and is being investigated for the treatment of presbyopia as a topical, once-daily drop delivered by a proprietary vehicle." According to Allergan, "the proposed mecha- nism of action of AGN-190584 is through contraction of the iris sphincter muscle, constricting the pupil to enhance the depth of focus and improve near and intermediate visual acuity while main- taining some pupillary response to light. AGN-190584 also contracts the ciliary muscle, facilitating accommodation." MicroLine (Eyenovia): This product is a pilocarpine solution administered with the company's Optejet dosing instrument. In June 2021, the company announced results from the Phase 3 VISION-1 clinical trial, which met its primary endpoint. Nyxol (Ocuphire Pharma): According to the company, "Nyxol is a preservative-free ophthalmic solution containing 0.75% phentolamine (or 1% phentolamine mesylate), a nonselective alpha-ad- renergic antagonist that inhibits the contraction of smooth muscle of the iris." It is currently being developed under the 505(b)(2) pathway for dim or night vision disturbances, reversal of pharmaco- logically induced mydriasis, and presbyopia. The company stated, "Phase 2 trials showed reduced pupil diameter, resulting in better contrast sensitivity and visual acuity." Enrollment in the VEGA-1 Phase 2 clinical trial was completed in May 2021, and the company was issued two patents related to the product in May. CSF-1 (Orasis Pharmaceuticals): CSF-1 is meant to repurpose existing and well-studied molecules, according to the company. Two Phase 3 clinical studies, NEAR-1 and NEAR-2, were initiated in Octo- ber 2020. PRX-100 (Presbyopia Therapies): According to the company, this product is "based on discoveries combining a proprietary vehicle with unique miotic combinations, without using pilocarpine. The drops are intended to induce strong miosis to create a significant pinhole effect with a depth of field enhancement, without any associated accommodative distance blur. PRX was developed to compli- ment current treatment options (not a permanent replacement for reading glasses, contact lenses or other options) and is reversible." BRIMOCHOL (Visus Therapeutics): According to the company, "BRIMOCHOL is a proprietary pupil-modulating eye drop that combines two well-studied, FDA-approved pharmaceuticals: car- bachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Together, they produce a 'pinhole effect,' which reduces the size of the pupil so that only centrally focused light rays are able to enter the eye, thereby sharpening distant and near images while minimizing side effects. The result is clarity of vision for near tasks like reading or using a smartphone." In March 2021, the FDA accepted an Investigational New Drug application for BRIMOCHOL, and the company announced the commencement of a Phase 2 clinical trial later that month. *This is not an exhaustive list, and there may be other presbyopia eye drops in development.

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