Cooling Anesthesia for Intravitreal Injection

Intravitreal injections have become the standard of care for administering medications for
retinal diseases such as age related macular degeneration and diabetic macular edema. There
is considerable apprehension among patients receiving these injections, primarily revolving
around adequate anesthesia during the injection. Current methods of anesthesia involve
topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which
suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage,
as well as significant time for the onset of anesthesia.

Recens Medical has developed a novel medical device which can precisely and rapidly cool the
surface of the eye This device cools to a temperature around -5 to -10 degrees Celsius, about
the temperature of a cold ice cube, and thus has an excellent safety profile compared to
conventional ophthalmic cryotherapy units. The value of such a device is both improved
patient comfort, as well as increased efficiency and workflow for retina specialists
administering intravitreal injections.

This device has been extensively tested in animal safety studies as well as pilot human
studies and has not demonstrated any serious adverse effects and has shown anesthetic effects
comparable to current standard of care.

This dose escalation study will test various temperatures and duration of temperatures to
evaluate for safety as well as determine the optimal temperature for anesthesia during
intravitreal injection.

Inclusion Criteria:

- Men and women > 18 years old at screening visit.

- Men and women who are undergoing intravitreal injections in either one eye or both
eyes with either Lucentis or Eylea as part of their normal standard of care with a 30
gauge needle.

- Subject has received a minimum of 3 intravitreal injections in the study eye prior to
the study visit.

- Subject is willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria:

- History of presence of scleromalacia

- Preexisting conjunctival, episcleral or scleral defects

- Less than 18 years of age

- Unable to provide informed consent

- Has received less than 3 injections in the study eye

- Active severe eye disease not controlled with artificial tears and requiring Restasis
or Xiidra drops.

- History of Endophthalmitis with intravitreal injection

- History of uveitis

- History of retinal detachment in either eye

- History of vitrectomy