Opus Genetics (IRD) Investor update summary

Clinical trial results and product updates

• Positive top-line results from VEGA-3 and LYNX-2 phase III trials for phentolamine ophthalmic solution 0.75% met primary endpoints, showing statistically significant and rapid, sustained improvements in near visual acuity for presbyopia and dim light disturbances.

• 27.2% of treated participants in VEGA-3 achieved a ≥15-letter improvement in binocular DCNVA at 12 hours post-dose on Day 8, compared to 11.5% on placebo (p < 0.0001).

• Significant patient-reported benefits were observed, including satisfaction with near vision upon awakening and improvements for night driving and glare reduction.

• No evidence of tachyphylaxis was observed over six weeks, and patients will continue to be monitored for long-term safety over 48 weeks.

• FDA granted Fast Track designation for phentolamine in chronic night driving impairment, with regulatory submission for presbyopia planned for the second half of 2025.

Safety and tolerability

• Safety profile was consistent with previous studies, with no treatment-related serious adverse events.

• Most common adverse events were mild, including conjunctival hyperemia, instillation site irritation, dysgeusia, and headache in 2.6% of patients.

Pipeline and strategic initiatives

• The pipeline includes gene therapies for inherited retinal diseases using a patented AAV vector approach, targeting conditions like Leber's congenital amaurosis, Best retinopathy, and retinitis pigmentosa.

• OPGx-LCA5 program received RMAT designation from the FDA, with initial pediatric data expected in Q3 2025; OPGx-BEST1 IND filing and phase I/II trial are planned for this year.

• The Retinal Degeneration Fund is providing non-dilutive funding for the OPGx-MERTK program, supporting pre-clinical and IND-enabling studies.

• Additional pre-clinical work is ongoing for gene therapies targeting RHO, RDH12, NMNAT1, and CNGB1 mutations.

• Cash position, bolstered by recent investments, is expected to fund operations into the second half of 2026.